Recent posts about medical affairs

The medical device industry is facing mounting pressure to adopt more rigorous publication management practices as regulatory requirements evolve. The International Society for Medical Publication Professionals (ISMPP) reports how current publication practices, largely shaped for the pharmaceutical industry, often fall short in addressing the unique needs of medical device companies.

While pharmaceutical companies have embraced robust publication planning models, medical device companies have lagged behind, but this is quickly changing as regulatory bodies demand higher standards of data reporting and transparency.

In light of these shifts, medical device companies need to rethink how they approach publication planning and dissemination. One potential solution? Embracing automation to streamline publication efforts and optimize resources.

Let’s dive into the unique publication management challenges that medical device companies face and discover how automation can help.

The unique challenges of medical device publication management

Medical device companies operate in a landscape vastly different from their pharmaceutical counterparts. While the pharmaceutical industry has established a standard approach to publication planning, the medical device sector presents several unique challenges that make this one-size-fits-all approach difficult to implement.

Challenge #1: Diverse medical device product portfolios

Medical devices range from simple surgical tools to highly complex implantable technologies, resulting in a product portfolio that’s far more diverse than that of pharmaceuticals. According to the World Health Organization, there are over 2 million medical devices available globally. This diversity means medical device companies may find it impractical to create publication plans for every product, especially for lower-priority or legacy devices.

How automation helps: Publication automation software can manage multiple publication plans across a diverse range of products, ensuring that even lower-priority devices receive adequate attention. With automation, companies can scale their publication efforts without overwhelming their internal teams.

Challenge #2: Shorter development timelines

Medical devices often have much shorter development timelines compared to pharmaceuticals — typically ranging from 3 to 7 years. This compressed timeline means there is less opportunity to gather and publish key data during development, and the focus tends to shift toward late-stage or post-market publications. Additionally, while pharmaceuticals can demonstrate safety and efficacy with shorter follow-up periods, certain medical devices (e.g., orthopedic implants) require years of post-market data collection to truly prove their long-term safety and effectiveness.

How automation helps: By automating data collection and publication workflows, medical device companies can ensure they are publishing relevant data throughout the device lifecycle — whether it’s pre-market, post-market, or during long-term surveillance. Automation helps keep up with fast-paced development timelines by streamlining the publication process.

Challenge #3: Limited resources and smaller budgets

The medical device industry typically operates with significantly smaller budgets compared to the pharmaceutical sector. This disparity often means medical device companies have smaller, multifunctional teams handling a range of responsibilities — including publication planning, regulatory submissions, and marketing communications.

How automation helps: With smaller teams, medical device companies can benefit from automation to handle repetitive tasks, streamline workflows, and free up resources for more strategic initiatives. Automation reduces the need for large, dedicated publication teams while ensuring consistency and quality across all publications.

How automation improves medical device publication processes

As medical device companies are increasingly expected to adopt more formal publication planning practices, automated publication solutions can provide critical support in overcoming the unique challenges they face.

1. Centralized data management

Automation software allows companies to collect, store, and manage data from multiple sources — preclinical studies, clinical trials, and post-market surveillance — within a single platform. This centralized approach makes it easier to access and use relevant data for various publications, ensuring that nothing is overlooked.

2. Task automation for multi-stakeholder input

Publication planning for medical devices often involves collaboration between different stakeholders. Manually managing these inputs can be time-consuming and error-prone. Task automation ensures that specific responsibilities and deadlines are automatically assigned to the right individuals, preventing bottlenecks and reducing the risk of missed input.

3. Real-time collaboration

Traditional publication processes can suffer from delays as documents are manually passed between reviewers. Automation platforms allow for real-time collaboration, enabling multiple stakeholders to provide input simultaneously without sacrificing version control or creating confusion. Real-time collaboration features speed up the review process and reduce delays, ensuring that publications are completed efficiently and accurately.

4. Audit trails and transparency

Regulatory bodies require transparency in how data is collected, reviewed, and published. This often involves detailed documentation of every step in the publication process, from data gathering to final approval.

Publication management software that offers built-in audit trails can track every action taken during the publication process, from edits to approvals. This ensures complete transparency and reduces the risk of regulatory non-compliance.

Long-term benefits of automating publications

By embracing automation, medical device companies can do more than just meet regulatory requirements — they can also position themselves for long-term success by delivering lasting benefits, such as:

• Maximized resource allocation: Automation helps medical device companies prioritize their publication efforts, allowing them to focus on high-priority products while ensuring that all necessary publications are completed. This optimizes resource allocation, even for smaller teams with limited budgets.
• Consistent publication output: Rather than reacting to the latest clinical trial results, automation helps medical device companies consistently publish data throughout a product’s lifecycle. This ensures a steady flow of information to HCPs and regulatory bodies, helping to build trust and maintain market presence.
• Stronger relationships with HCPs: Healthcare providers rely on published data to make informed decisions about which medical devices to adopt. By using automation to streamline publication efforts, medical device companies can ensure timely, transparent data dissemination that strengthens relationships with HCPs.

The path forward for medical device publications

As the medical device industry adapts to evolving regulatory demands, adopting publication automation software can help streamline processes, reduce inefficiencies, and ensure that all publication activities are aligned with best practices. By embracing automation, medical device companies can overcome many of the challenges they face — maximizing resource efficiency, improving regulatory compliance, and consistently delivering high-quality publications.

For medical device companies looking to bridge the gap between complex product portfolios and rigorous publication management, automated publication management software, like PubPro, is the key to success.

In the life sciences industry, even the best-laid plans can be derailed by circumstances beyond a company’s control.

Regeneron Pharmaceuticals faced such a challenge on August 20, 2024 when the U.S. Food and Drug Administration (FDA) issued a Complete Response Letter (CRL) delaying the approval of linvoseltamab, the company’s promising treatment for multiple myeloma. This delay wasn't due to the drug's efficacy or safety profile — elements typically within the control of medical affairs teams — but rather stemmed from issues at a third-party manufacturing facility, a factor entirely outside of Regeneron’s direct control.

This situation highlights a crucial reality for medical affairs professionals: external factors can disrupt even the most meticulously executed plans. Despite having little to no control over these disruptions, medical affairs teams are often at the forefront of managing the fallout.

This article explores the types of challenges that can arise in such situations and discusses how strong communication and risk management strategies can help mitigate the impact of these external disruptions.

How external disruptions impact medical affairs

1. Regulatory delays due to manufacturing issues

In Regeneron’s case, the FDA’s decision to issue a CRL was driven by findings during a pre-approval inspection at a third-party fill/finish manufacturer. Despite Regeneron’s internal teams executing their roles effectively — achieving strong efficacy data and preparing a robust submission — the regulatory approval process was stalled due to external manufacturing issues.

• Impact on Medical Affairs: Medical affairs teams, while not directly involved in manufacturing, must manage the consequences of such delays. This can include adjusting timelines for product launches, re-aligning communication strategies with healthcare professionals (HCPs), and ensuring that any information about the delay is accurately conveyed to stakeholders.
• Key Takeaway: Proactive communication with regulatory bodies, HCPs, and internal stakeholders is critical. Medical affairs teams should be prepared to explain the nature of such delays, emphasizing that the drug’s efficacy and safety remain uncompromised, while managing expectations around new timelines.

2. Impact on product launch timelines

The delay in regulatory approval inevitably impacts product launch timelines. For a company like Regeneron, which was positioning linvoseltamab as a competitor in the blood cancer market, the delay not only postpones potential revenue but also affects market strategy, competitive positioning, and relationships with HCPs and patients who might have been awaiting this new treatment option.

• Impact on Medical Affairs: Medical affairs teams must navigate the reputational risks associated with delayed launches. HCPs, patients, and other stakeholders may express frustration or lose confidence in the company, regardless of the reason for the delay.
• Key Takeaway: Strong communication strategies are essential. Medical affairs teams should provide clear, transparent updates to all stakeholders, including details on revised launch timelines, to maintain trust and manage expectations.

3. Reputational risk and communication challenges

Regeneron’s situation also underscores the reputational risks that arise when external factors cause delays. The company now faces the challenge of maintaining its reputation as a leader in the oncology space while managing the perception of its manufacturing capabilities.

• Impact on Medical Affairs: Medical affairs teams are often the first line of defense in protecting the company’s reputation. They must ensure that all communications — whether with HCPs, patients, or the media — are consistent, accurate, and reinforce the company’s commitment to patient safety and product quality.
• Key Takeaway: Crisis communication plans should be in place to quickly address and mitigate reputational damage. Medical affairs teams should work closely with public relations and marketing departments to ensure that all messaging aligns with the company’s values and commitments.

4. Dependency on external partners

Regeneron’s reliance on a third-party manufacturer is a common scenario in the pharmaceutical industry. While outsourcing can be cost-effective and efficient, it also introduces risks that are largely out of the control of internal teams.

• Impact on Medical Affairs: Medical affairs teams must manage the consequences of issues that arise from external partnerships. This includes responding to delays or quality concerns that were not caused by internal processes but still impact the company’s ability to deliver on its promises.
• Key Takeaway: Robust risk management strategies are crucial. Medical affairs teams should regularly assess the risks associated with external partnerships and develop contingency plans for potential disruptions. This includes having alternative communication strategies and being prepared to address any concerns raised by HCPs or patients.

Mitigating the impact: The role of communication and risk management

The Regeneron case highlights the importance of strong communication and risk management strategies in mitigating the impact of challenges that are beyond the control of medical affairs teams. Here are some key strategies:

Proactive communication

• Regularly update stakeholders about potential risks and any steps being taken to mitigate them.
• Ensure that messaging is clear, consistent, and aligned across all channels.

Crisis management planning

• Develop crisis communication plans that include protocols for dealing with delays, regulatory setbacks, and other disruptions.
• Conduct scenario planning exercises to prepare for various challenges that could arise from external factors.

Strengthening external partnerships

• Build strong relationships with external partners, emphasizing the importance of maintaining high standards and clear communication.
• Regularly review and assess the performance of external partners to identify potential risks early.

Risk assessment and contingency planning

• Continuously assess risks associated with external dependencies and develop contingency plans to address potential disruptions.
• Ensure that these plans include clear roles and responsibilities for the medical affairs team in managing the fallout from any issues.

Mastering the response to external challenges

The Regeneron case serves as a reminder that even the most well-executed strategies can be derailed by factors beyond a company’s control. For medical affairs teams, the key to managing these challenges lies in strong communication, proactive risk management, and the ability to adapt quickly to changing circumstances. By implementing these strategies, medical affairs teams can help mitigate the impact of external challenges, protect their company’s reputation, and maintain the trust of HCPs, patients, and other stakeholders.

While medical affairs teams may not be able to control every aspect of the drug development and approval process, they can certainly control how they respond to challenges — and in doing so, play a critical role in the success of their organization.

During clinical drug trials, ensuring patient safety and maintaining regulatory compliance is of paramount importance.

Even promising results can be accompanied by complexities and challenges associated with adverse event (AE) management, as demonstrated in Avidity Biosciences’ recent Duchenne muscular dystrophy (DMD) trial.

With the increasing complexity of clinical data and the heightened scrutiny from regulatory bodies, the need for a robust and efficient adverse event management process has never been more critical.

The challenges of adverse event management in clinical trials

Clinical trials, by their very nature, involve the administration of investigational treatments to patients, which can lead to unforeseen adverse events. These events must be meticulously tracked, analyzed, and reported to ensure patient safety and regulatory compliance. However, the traditional methods of managing AEs — often reliant on manual processes, spreadsheets, and fragmented data systems — are no longer sufficient to meet the demands of modern clinical research.

In the case of Avidity Biosciences, their DMD trial highlighted the importance of managing adverse events with precision and speed. According to Fierce Pharma, two patients dropped out of the trial after experiencing treatment-emergent adverse events — including one case of anaphylaxis.

The complexity of these events and the need for rapid, accurate data interpretation underscore the importance of having a streamlined AE management system in place.

The role of automation in enhancing safety and compliance

Enter automation. By integrating automated tools into the AE management process, clinical trial teams can significantly enhance their ability to monitor, manage, and report adverse events.

MIRador, a cutting-edge medical information request (MIR) management solution, is designed to address these exact challenges, offering a suite of features that streamline AE handling and ensure compliance with regulatory standards.

1. Streamlined data collection and triage

One of the primary benefits of automation in AE management is the ability to streamline data collection and triage processes. MIRador’s automation capabilities allow clinical teams to gather AE data from multiple sources—including patient records, clinician reports, and laboratory results—and consolidate it into a single, centralized platform. This not only reduces the risk of data fragmentation but also ensures that all relevant information is captured accurately and promptly.

Automated triage features enable the system to prioritize AEs based on severity and urgency, ensuring that the most critical events are addressed first. This is particularly crucial in scenarios like Avidity’s trial, where swift action could mean the difference between life and death for patients experiencing severe reactions.

2. Accelerated analysis and reporting

Time is crucial in clinical trials. MIRador’s advanced analytics tools allow for the rapid analysis of AE data, helping clinical teams identify patterns and potential safety signals more quickly than traditional methods. This accelerated analysis not only improves decision-making but also facilitates timely reporting to regulatory authorities, a key factor in maintaining compliance.

For any trial, the ability to quickly analyze and address adverse events, such as the anaphylaxis case in Avidity’s trial, is critical for patient safety and regulatory adherence. The ability to generate standardized reports at the click of a button ensures that all necessary documentation is prepared and submitted on time, reducing the risk of regulatory penalties.

3. Enhanced compliance and risk mitigation

Compliance with regulatory requirements is non-negotiable in clinical trials. MIRador’s automation features include built-in compliance checks that ensure all AE management processes adhere to the latest regulatory guidelines. This is particularly important in the context of adverse event reporting, where even minor deviations from protocol can result in significant fines or delays in trial progress.

By automating these compliance checks, MIRador helps clinical teams avoid common pitfalls, such as incomplete documentation or missed reporting deadlines. Additionally, the system’s audit trails provide a transparent record of all actions taken, offering an extra layer of protection in the event of an audit or investigation.

Safeguarding patient safety and trial integrity with MIRador

The complexities of clinical research, as seen in the Avidity Biosciences trial, highlight the importance of effective adverse event management. By leveraging automation through tools like MIRador, clinical trial managers, medical affairs professionals, and compliance officers can enhance their ability to manage AEs, ensure patient safety, and maintain regulatory compliance.

MIRador’s suite of features — streamlined data collection and triage, accelerated analysis, and enhanced compliance — empowers clinical teams to manage AE challenges effectively. This approach safeguards the integrity of trials and contributes to the development of safer, more effective treatments for patients.

As clinical research evolves, integrating automation into AE management processes will become increasingly important. By adopting solutions like MIRador, life sciences organizations can ensure that their trials are conducted with the highest standards of safety and compliance.

Ready to learn more about automating your adverse event management process and ensuring your trials are conducted with the highest standards? Request a demo of MIRador today.

As the life sciences industry evolves, medical affairs teams are left wondering why software solutions haven't kept pace with their needs. Despite increased competition in the field, developers seemingly fall short in coping with the whirlwind of information assets in as highly regulated industries as the life sciences.

"We're well into the 2020s, but medical affairs departments are still relying heavily on brute force communication," said Michelle Chernock, founder and CEO at Leaders in Medical Affairs. "They still have too many files stored on desktops, constantly struggle with version control, and rely on relationships to ensure processes are completed and that information flows to the right place at the right time."

Chernock stressed that the lack of centralization of processes is a "major obstacle" within medical affairs. Pharma professionals often resort to clunky manual tools that can be redundant and, at worst, unable to integrate with each other when tasked with updating or streamlining processes for functions like:

• Publication management
• Medical, legal, and regulatory reviews
• Grants committee work
• Deck development
• Training

The three typical approaches to medical affairs software

Software for medical affairs departments often boils down to three options: utilizing large, expensive, and complex software systems, cobbling together multiple smaller tools, or outsourcing their entire medical communications workflow.

Each of these paths comes with significant drawbacks, leaving teams stuck between complexity and chaos. Let's explore each one:

1. Large, expensive, and complex software

Enterprise-level software solutions like iEnvision and PubStrat represent one end of the spectrum.

These platforms are comprehensive and robust, offering features for content creation, regulatory review, submission, security, compliance, and scalability. However, their benefits are often overshadowed by their high costs and steep learning curves, requiring extensive user training.

Additionally, their rigid structures may not adapt well to specific workflows, and their limited integration capabilities can create data silos, leading to inefficiencies. These vendors also often lack a partnership approach, providing minimal support beyond standard service agreements.

2. Multiple smaller tools cobbled together

On the other end of the spectrum, some teams opt for a piecemeal approach, combining multiple specialized tools for different tasks. This approach might involve using Veeva for document management, separate software for reference management, and manual tools for collaboration.

While this method can reduce costs and leverage familiar tools, it introduces significant inefficiencies and risks. Manual data transfer, juggling multiple systems, and frequent context switching can be time-consuming and error-prone.

Additionally, the lack of centralization hinders collaboration and visibility, and integrating these disparate systems can be complex and expensive, often leading to incomplete solutions that fail to scale efficiently.

3. Outsourcing all medical communications

Outsourcing medical communications to specialized agencies is another alternative. These agencies bring expertise in scientific writing, regulatory compliance, and effective communication with healthcare professionals and patients.

Outsourcing can be cost-effective, scalable, and efficient, allowing organizations to focus on their core competencies.

However, it also involves loss of control over project timelines and communication styles, potential challenges in maintaining internal knowledge, confidentiality concerns, and integration issues between internal and external teams.

Real-life case study on the challenges of medical affairs software

Peter Herout experienced these challenges firsthand as Associate Director of Scientific Communications at Esperion Therapeutics, a company focused on cardiovascular disease prevention medication. After first joining the company, Herout encountered significant issues with their publication management software, including a steep learning curve for users.

"The software was also slow – maybe because of the complexity of it, or the interface," added Herout. "It’s not efficient to wait for the program to respond to searches or uploads."

To top it off, the software provider offered poor customer service and slow response to problems encountered with the system, causing further delays.

"Clunky systems that are not user-friendly and require too much non-productive effort lead to internal users delaying or avoiding tasks," Chernock explains. "In some cases, data in disconnected software systems can become unreliable (e.g. a zip code is changed in one system and not in others). This lack of data integrity adds to the frustration of users who can no longer rely on their software as a source of truth."

In the case of Esperion, Herout sought a more user-friendly interface that would guide users through workflows with clear prompts. They also desired secure links that would allow reviewers to access tasks without the constant need to log in.

For Herout, the ideal solution should act as a central hub for all communication activities, fostering collaboration and efficiency while being adaptable to the specific needs and standard operating procedures (SOPs) of each organization.

"I wanted a solution within which multiple different types of reviews can occur," Herout explained, "whether it be for publications, standardized response documents, investigator-initiated study protocol review, etc."

It would also need to balance the powerful functionality of enterprise systems with the user-friendliness of smaller tools.

"It primarily comes down to resources/cost and are all of the components or functions applicable to the company’s needs," Herout said. "A lot of bells and whistles may not be needed and complicate workflow."

Finding a happy medium

It’s clear that the current landscape of medical affairs software is fraught with challenges. Teams often must choose between expensive, complex systems or inefficient, piecemeal solutions. Outsourcing is another option but comes with its own set of issues.

The industry is ready for "happy medium" software solutions that offer robust functionality while remaining user-friendly and adaptable to specific organizational needs. These solutions would not only streamline operations but also enhance collaboration, efficiency, and overall productivity in medical affairs.

When Esperion Therapeutics began evaluating options to replace their publication management software, they focused on five key selection criteria that were crucial for sourcing a "happy medium" solution. This criteria was instrumental in guiding their decision to ultimately select PubPro.

Let’s explore those five criteria:

1. Usability

Esperion’s previous system was cumbersome and difficult to navigate, leading to inefficiencies and frustration among users. PubPro was chosen for its intuitive interface, which minimized the learning curve and allowed users to quickly adapt to the new system.

Features like role-specific dashboards and deep linking, which enables secure, password-free access for external stakeholders, were particularly appealing. This user-friendly design was critical in streamlining Esperion’s processes and reducing the time and effort required to manage their publications.

2. Configurability

The inability to customize their previous software to fit Esperion’s specific SOPs was a major pain point. PubPro stood out for its high level of configurability, allowing Esperion to tailor the system to their unique workflows without the need for extensive development work. This flexibility ensured that the software could evolve alongside Esperion’s needs, making it a long-term solution that could grow with the company.

3. Integration capability

Esperion needed a solution that could seamlessly integrate with their existing tech stack. PubPro’s strong integration capabilities addressed this need, enabling a more cohesive and efficient workflow. By eliminating data silos and reducing manual data entry, PubPro significantly improved the overall efficiency of Esperion’s publication management process.

4. Reporting and analytics

Effective tracking and reporting were essential for Esperion to monitor project progress and ensure compliance. PubPro’s robust analytics tools provided real-time data and customizable reports that allowed Esperion to maintain visibility over their publication processes. This capability was crucial in helping them identify bottlenecks, optimize workflows, and make data-driven decisions.

5. Responsive support

A key factor in Esperion’s decision to move away from their previous vendor was the lack of responsive customer support. PubPro, on the other hand, offered a high level of customer service, including quick response times and effective problem resolution. This support was vital during the implementation of PubPro, which was completed in under three months, and continues to be an important aspect of Esperion’s positive experience with the platform.

Striking the right balance, setting a new standard

Esperion’s publication management software choice exemplifies the "happy medium" that medical affairs teams have been seeking — a solution that not only keeps pace with the evolving demands of the industry but also effectively manages the complexities of highly regulated environments like life sciences. By addressing the shortcomings of traditional software options, Esperion enhanced usability, configurability, integration, and support.

As the industry continues to evolve, Esperion’s story stands out as a model for how software can and should meet the needs of modern medical affairs teams.

Level up your medical affairs team

Want to learn more about how PubPro transforms publication management processes? Read Esperion’s full customer story or contact BP Logix to request a free PubPro demo.

The world of drug development is evolving rapidly, and nowhere is this more apparent than in the realm of accelerated approvals.

Established in 1992 in response to the HIV/AIDS crisis, the FDA's Accelerated Approval pathway has been a critical tool for getting life-saving drugs to patients faster than ever before. However, recent controversies, such as the approval of the Alzheimer's medication Aduhelm in June 2021, have highlighted the need for stricter regulations around accelerated approvals.

To address this issue, the FDA is proposing new requirements for drug companies to conduct confirmatory studies and provide greater transparency around the results.

Let’s explore the implications of these new requirements and how publication management software solutions like PubPro can help with potential challenges.

FDA drug approval woes: How we got here

The FDA's Accelerated Approval pathway has come under fire in recent years due to concerns about the quality of evidence used to support accelerated approvals as well as the lack of timely follow-through on confirmatory studies afterwards.

Let's talk about one of the most recent controversies.

Imagine a new drug comes onto the market that promises to change the game for Alzheimer's patients. Sounds great, right? But what if the evidence supporting this drug's approval was shaky at best, and the price tag was exorbitant? That's exactly what happened with Aduhelm, which received accelerated approval from the FDA in 2021. This drug removes sticky amyloid plaque from the brain, but because there was no proof that the ability to remove this plaque slows the deterioration of patients' mental faculties, insurers refused to cover its $56,000-per-year price tag.

The controversy surrounding Aduhelm brought the Accelerated Approval pathway into the spotlight and sparked a national conversation about the need for stricter regulations.

A recent report by NPR found that a staggering 42% of confirmatory drug studies required after accelerated FDA approval were either delayed for more than a year or hadn't even started yet.

This highlights the crucial importance of the FDA's new requirements for drugmakers to ensure timely and effective completion of these studies, as well as improved reporting to increase transparency around the pathway.

The role of technology in meeting new FDA requirements

While the FDA's new regulations for accelerated drug approvals are necessary, they pose a challenge for life science companies that must comply with them. These companies are now required to ensure timely and effective completion of confirmatory studies, as well as improved reporting to increase transparency around the pathway. These new requirements can be time-consuming and laborious, but luckily technology can alleviate some of these challenges.

Enter PubPro, a publication management solution that can help life science companies comply with the FDA's new requirements for accelerated drug approvals in two key ways:

Benefit #1: Ensure timely and effective completion of confirmatory studies

The FDA now has more leverage to hold drug companies accountable for their promises about conducting confirmatory studies as a condition of accelerated approval. Drugmakers must ensure they are completing their studies in a timely and effective manner or face potential consequences such as fines or even loss of approval.

PubPro can help drugmakers manage and automate this process, allowing them to easily track confirmatory studies and ensure they meet their regulatory obligations. Here are some of PubPro's key publication management features that can help:

• Automated reviewer assignments ensure that the right people are assigned to review and provide feedback on the necessary documents.

• With its collaborative document editor, PubPro provides a centralized platform for reviewers and authors to communicate and make revisions in real-time, reducing the time it takes to consolidate and implement revisions.

• PubPro's automated reminders and notifications ensure that confirmatory studies are conducted and completed on time, preventing delays and noncompliance.

With these tools, drugmakers can streamline their confirmatory study process and stay on top of their regulatory obligations, ensuring that they comply with the FDA's new requirements and avoid potential consequences.

Benefit #2: Prove compliance and simplify reporting for confirmatory studies

The FDA's new transparency requirements mandate that drugmakers promptly report their confirmatory studies' results, which poses a challenge because drug companies must ensure they can meet these reporting requirements while also ensuring compliance with the FDA's regulations.

PubPro helps alleviate this challenge by providing companies with the tools they need to easily track and manage these reports in a timely and compliant manner. Here's how:

• PubPro's audit tracking abilities allows drugmakers to provide evidence of compliance with FDA requirements, demonstrating that they follow the necessary procedures and processes.

• With PubPro's configurable reporting, drugmakers can generate comprehensive reports for proving compliance, making it easy and quick to ensure all requirements are met.

With these features, PubPro simplifies the reporting process, allowing drug companies to ensure compliance with the FDA's transparency requirements while reducing the time and effort needed to do so.

Streamline publication management with PubPro

PubPro is the ultimate solution for life science companies struggling to comply with the FDA's new requirements for accelerated drug approvals.

By automating key tasks and streamlining the publication management process, PubPro ensures life science companies can stay on top of their regulatory obligations and maintain positive relationships with the FDA.

Stay on top of new FDA regulations

Get in touch today to learn more about how PubPro can help your life science company comply with the new FDA requirements and ease the burden of compliance efforts.

An adverse event report (AER) is a self-initiated medical report detailing an undesirable clinical outcome associated with a medication or medical device. The reports fall under the umbrella of medical information requests (MIRs), as both are initiated by providers or consumers and are then directed at pharmaceutical companies or medical device manufacturers.

AERs are typically generated by physicians, though manufacturers or consumers may also submit them. Regardless, adverse event reporting is critical to patient safety and the refinement of medications. Without the information provided by AERs, manufacturers would be unable to track the frequency of unfavorable events or monitor the severity of unintended clinical outcomes.

By leveraging adverse event reports, manufacturers can continuously improve their products, protect consumers, and remove potentially dangerous medications from circulation. However, although virtually every entity in the life science and healthcare industry understands the importance of adverse event reporting, many struggle to efficiently manage their AERs.

As part of our efforts to expedite adverse event reporting, we have identified some common forms of adverse events, outlined the challenges associated with their AER submission, and provided some strategies to circumvent these roadblocks. Care providers and other entities in the life science and healthcare sectors can use the insights below to promote compliance and expedite reporting.

Types of adverse events

Any unintended and undesirable clinical outcome caused by an administered medication can be categorized as an adverse event. Some of the adverse events that warrant an AER include the following:

• Unexpected or harmful side effects brought on by drugs or medical devices

• Overdoses or accidental exposure to unnecessary medications

• Issues related to product quality, purity, or potency

• Cases of medical errors or problems related to product labeling or packaging

• Environmental or occupational exposure to chemicals or other substances

• Incidents that fall into the above categories should be classified and documented via an adverse event report in most instances.

Failing to file an AER promptly and efficiently can expose a provider and their organization to significant liability while endangering patients and hindering manufacturers’ ability to improve their offered medications or devices.

Reporting unexpected or harmful side effects is particularly important and time-sensitive. Such occurrences must be reported as soon as possible to relay the information to the Food and Drug Administration (FDA) and the product manufacturer.

When filing reports, providers must differentiate between side effects that were explicitly harmful to the patient and those that were simply unexpected. For instance, suppose a provider prescribes a new headache medication to some patients. One patient reports nausea and vomiting, whereas another finds the drug improved their sleep quality.

While the pharmaceutical company needs to know about each incident, reports are documented using distinct processes. Therefore, both outcomes should be properly reported; the negative effect through an AER and the positive result via a medical information request form.

The challenges of adverse event reporting

Adverse event reporting is a relatively straightforward process: Providers should promptly report any undesirable clinical outcome caused by a medication or device. Despite its relative simplicity, however, the reporting process is muddled due to a wide range of confounding factors, including the following:

Regulatory compliance

Adverse event reporting is a tightly regulated process, and companies that fail to adhere to these strict ordinances can incur hefty penalties and lawsuits. Additionally, non-compliant organizations will likely suffer long-lasting reputational damage, which could negatively impact consumer trust for years.

Unfortunately, a single governing body does not set adverse event reporting regulations. While the FDA does establish many AER protocols, companies must also contend with their state-specific regulations. Navigating a single set of regulatory guidelines can be challenging enough, so keeping up with multiple sets of continuously evolving requirements is undoubtedly even more difficult.

Data silos

Far too often, adverse event data is stored in multiple systems across different departments. When data is scattered and stored on disparate software solutions that don’t properly communicate, the details surrounding adverse events will get lost in the shuffle.

Data silos hinder the proper documentation of AERs and make it challenging to submit or manage any medical information requests. Organizations in such scenarios often struggle to track and analyze adverse event information, much less report it within established time constraints.

Therefore, businesses must proactively work to eliminate data silos while maintaining their AER and MIR compliance. Doing so will also promote better organizational efficiency and improved collaboration among team members.

Adopting a modern, fully-integrated reporting solution is the most practical way to tear data silos down. A platform like BP Logix’s MIR solution facilitates the seamless tracking and analysis of all outstanding medical information requests, including adverse event reports. Organizations can ensure they meet regulatory requirements and preserve their reputations.

Managing large volumes of data

Adverse events include a broad array of harmful and unintended clinical outcomes. As a result, organizations are bound to rack up a large volume of AERs, and keeping up with that data can prove quite challenging.

Entities not adopting streamlined data management workflows will struggle to respond to AERs within established time constraints, leaving the door open to compliance violations and penalties.

As part of their data management protocols, organizations must also be able to categorize and prioritize their AERs. More significant adverse events, such as hospitalization, need to be addressed before less pressing ones.

Responses must be timely

Delays in adverse event reporting can be highly detrimental to an institution’s reputation. More importantly, they can pose a serious risk to patients. The longer potentially dangerous or compromised batches of medication remain in circulation, the higher the chances are for a severe event, such as permanent injury or death. Even a single negligence-related death or injury can expose an organization to significant legal repercussions.

For instance, let’s say that a physician’s patient is hospitalized due to a severe reaction to a medication. The physician does their due diligence, immediately submitting an AER to the manufacturer, but that manufacturer does not have a means of prioritizing its AERs. Instead, it processes them in the order they were received, which means the original AER is not responded to for upwards of 30 days. During that time, two dozen other patients are hospitalized.

The above example might seem somewhat hyperbolic, but it illustrates the dangers of adverse event reporting delays in that they magnify an organization’s risk. Therefore, life science entities must make every effort to expedite their reporting and response processes.

Complex processes

Generating and responding to AERs can be an incredibly involved, complex process. Even a single AER may require input from multiple stakeholders, such as regulatory bodies, internal teams, and healthcare providers. The process becomes even more complicated when patients are directly involved in adverse event reporting.

While there is no way to remove stakeholders from the equation, organizations can facilitate better collaboration and information sharing by breaking down communication barriers between these entities. When stakeholders can efficiently provide and relay their insights, the reporting process becomes streamlined.

How to overcome these challenges

Adverse event reporting is an intricate procedure that involves dealing with several different hurdles. Still, although there is no singular solution for overcoming these challenges, organizations can simplify and expedite their AER processes by proactively eliminating points of friction.

Specifically, companies striving to facilitate more efficient adverse event reporting should do the following:

Establish clear internal procedures and guidelines.

Though they may seem obvious, some organizations do not have clear, repeatable processes for adverse event reporting. When reporting guidelines are unclear and easy to follow, errors are bound to occur.

Any organization interested in revamping its AER management strategies should reevaluate its internal procedures and guidelines, gathering feedback from employees that submit or receive AERs. Doing so will help stakeholders make meaningful improvements to existing protocols.

Use a centralized adverse event reporting system to eliminate silos/improve visibility

Adverse event reporting will always be an organizational pain point if data silos exist. In light of such, organizations must replace their antiquated, disparate reporting systems with a centralized alternative. Aggregating all adverse event reports into a single platform allows businesses responsible for processing or responding to AERs to promote better visibility and improve compliance.

Adopting a unified database will improve AER visibility, eliminate data silos, and promote enhanced medical information request management. Addressing MIR and AER management is critical to compliance within the life science and healthcare verticals. An organization that succeeds at both will be able to foster trust among its consumers and providers while also avoiding any regulatory penalties.

Implement process automation to reduce errors

Deploying a centralized AER management database is a significant step toward better efficiency and compliance. Still, if adverse event reporting workflows continue to rely on manual inputs, they will always be plagued by human errors. Organizations tasked with AER management should implement process automation tools like BP Logix’s MIR solution to combat errors and further mitigate risks.

Our dynamic platform enables entities to automate traditionally tedious, manual processes, in turn freeing up AER management teams to tackle more dynamic tasks while simultaneously reducing the frequency of errors and mitigating their risks. BP Logix’s MIR solution integrates into an organization’s existing reporting system and can be tailored to meet the needs of nearly any healthcare or life sciences entity.

Leverage predictive analytics to identify trends

When AERs are dispersed across an entire team, detecting and tracking trends among them can be tricky. The longer a concerning pattern of adverse events goes undetected, the more likely it is to result in reputational damage and patient harm.

With that in mind, companies must incorporate data analytics software into their AER management workflows. Analytics and machine learning tools can detect trends as soon as they emerge, allowing stakeholders to use real-time data to guide decision-making processes.

Provide training and support to employees

Although workflow automation technologies can improve reporting efficiency, employees will always be the backbone of any AER initiative. Adverse event reporting will remain a challenge without talented, well-trained, confident workers.

Therefore, decision-makers must invest in employee training and upskilling efforts to turn AER management into an organizational strength, all of which must be designed with the employee in mind.

Generally speaking, it is best to avoid long, tedious training blocks and break down programs into smaller, easier-to-digest sessions. Such an approach can improve information retention and help team members get the most out of each training session.

Ensure compliance with regulatory requirements with regular audits

The abovementioned strategies should significantly improve an organization’s adverse event reporting processes. Still, organizational leaders must ensure compliance with regulatory requirements by conducting regular audits and process reviews. These reviews will reveal which tactics are working and what shortcomings still exist within the AER management strategy of the business.

If possible, organizational leaders should outsource audits to ensure objectivity. Using a third-party auditing firm can also provide additional insights, as the outside source may be able to offer a fresh perspective on old business challenges.

Modernize adverse event reporting

While many challenges are associated with adverse event reporting, your organization must navigate each to ensure compliance and preserve its reputation within the healthcare community.

You can create a dynamic strategy to facilitate streamlined reporting by leveraging the adverse event reporting tactics outlined above. When you pair that strategy with BP Logix’s robust MIR management solution, you can further expedite your reporting processes and achieve ongoing compliance.

BP Logix’s platform includes a suite of automation and visibility tools designed to help you track MIRs and adverse events throughout the reporting process. You can prioritize time-sensitive requests and avoid reporting mishaps that expose your business to fines or other penalties. Additionally, our solution reduces instances of human error and facilitates complete reporting of adverse events.

If you are ready to rethink how you manage adverse event reporting, explore BP Logix’s MIR solution to learn more.

Medical information request management is undoubtedly one of the most important functions of medical affairs teams that operate within the life sciences space.

Be that as it may, processing medical information requests (MIRs) has, historically, proven to be a challenging, tedious, and time-consuming task that ties up essential resources and exposes pharmaceutical entities to compliance issues, which can lead to fines, reputational damage, and other penalties that threaten profitability and business continuity.

Fortunately, organizations that produce pharmaceuticals and medical devices can mitigate these risks by implementing a versatile information request management system (IRMS) solution. Modern IRMS software empowers organizations to rethink how they handle medical information requests, promote efficiency, and facilitate compliance.

With that said, there is a sizable number of IRMS software solutions on the market today, which can make it difficult for life science entities to find the right platform for the needs of their organization. To help expedite your search, we’re walking through some must-have features and attributes to look for when exploring IRMS software for your company.

What are medical information requests?

MIRs are self-initiated, unsolicited requests made by a healthcare professional and submitted when a clinician or other healthcare professional needs to obtain technical, scientific, or medical information about a product that is not readily available in its instructions for use (IFU) or initial prescribing information.

There are several different types of MIRs, including adverse event reports (AERs), product complaints, general requests for information, and notifications about potential off-label effects or uses. Due to the broad scope of MIRs, it is important that all inbound requests are quickly reviewed, categorized, and assigned to the appropriate medical affairs team members.

Why manual MIR processing falls short

Medical information requests are commonly received via shared inboxes and subsequently tracked via spreadsheets, but any organizations that have used or are currently using such an approach can attest to its inefficiency.

When multiple team members are using the same inbox to receive and process inbound requests, it is all too easy for MIRs to slip through the cracks. Similar issues arise when medical affairs personnel are tracking dozens of MIRs at once, with spreadsheets that are scattered about their organization’s network.

For instance, let’s say that your team uses both spreadsheets and a shared inbox. When the medical affairs team returns to the office on a Monday morning, they have several dozen new MIRs in the joint inbox, which means that each team member is assigned to handle a specific type of request (adverse events, general requests, etc.).

As each staff member begins filtering out the requests that fall under their purview, the individual that is tasked with responding to general MIRs accidentally moves an AER to their personal inbox. They don’t notice their mistake until the following day, at which time they reroute it back to the shared inbox. However, since the message is already showing as “read,” the team member tasked with handling AERs does not see the message for several days, resulting in a delayed response to a time-sensitive MIR.

When your organization bases its MIR processing protocols around such antiquated technologies and procedures, even if they’re detail-oriented, talented medical affairs teams are bound to make these sorts of mistakes on occasion. Even a single oversight can lead to serious financial consequences and set the stage for irreparable damage to your organization’s reputation. Therefore, automating the MIRs of your life sciences entity with IRMS software should be a top priority.

Automating MIRs with IRMS software

Manually handling MIRs only serves to bog down medical affairs teams and limit their productivity. Additionally, inefficient manual MIR processes diminish the experience of healthcare professionals and their patients, creating compliance headaches and making it nearly impossible for teams to respond to requests in a timely manner.

Fortunately, organizations in the pharmaceutical and medical equipment sectors can circumvent these issues by adopting IRMS software.

These technology suites include tools that enable medical affairs teams to automate traditionally manual, tedious MIR-related tasks, such as report intake and analysis. The most robust IRMS software solutions also assist with categorizing, prioritizing, and responding to medical information requests, thereby streamlining every touchpoint of MIR processing.

With IRMS software, medical affairs teams will no longer be inundated with a seemingly endless list of pending MIRs. Instead, they can effortlessly respond to each request, generate detailed reports, relay information to healthcare professionals, and ensure compliance with relevant regulatory requirements.

Benefits of an IRMS software

The benefits of IRMS software are significant and far-reaching. By implementing such a solution, organizations in the pharmaceutical and medical equipment industries can achieve the following:

Improve efficiency

Using inefficient processes, like using a shared inbox to receive requests or leveraging spreadsheets to track outstanding MIRs, sets the stage for delayed responses and missed deadlines, which can cause frustration among healthcare professionals, endanger patients, and diminish trust in an organization.

An IRMS software solution can improve end-to-end MIR processing efficiency by providing medical affairs teams with the tools and technology they need to maximize productivity. They can automate intake processes, categorize and prioritize inbound MIRs in seconds, and distribute each request to the appropriate staff member, making missed requests and delayed responses a thing of the past.

Enhance compliance

The pharmaceutical and medical device sectors have long been, undoubtedly, some of the most tightly regulated industries. In recent years, state and federal authorities have enacted even more stringent regulations, which not only raise the bar for compliance but also include severe penalty schedules for violators.

IRMS software can help ensure compliance with state and federal regulations by facilitating timely, transparent, and efficient responses to medical information requests. Upon receiving a request, medical affairs teams can quickly begin processing the MIR and conveying the appropriate information to the submitting healthcare professional.

Furthermore, IRMS software supports additional compliance by providing teams with analytics tools they can use to monitor and improve the efficiency of their MIR processes.

Facilitate better data management

Tracking medical information requests with spreadsheets creates data silos and leads to a lack of MIR visibility. In other words, MIRs can end up overlooked, misplaced, or outright lost, and when that happens, medical affairs teams are bound to provide delayed responses or relay inaccurate or otherwise incomplete information to those requesting it.

Transitioning to a centralized IRMS software solution will facilitate better, more transparent data management. Medical affairs teams, compliance personnel, and decision-makers will be able to easily view how many MIRs are in the pipeline, what the status of each request is, and other important factors. They can then use that information to ensure that response deadlines are met while also monitoring the efficacy of MIR processes.

What to look for when choosing an IRMS solution

Investing in an IRMS solution is a major decision that will have a profound impact on patient and healthcare professional experiences. The platform that your team chooses to implement will also affect compliance, which is why you must carefully evaluate each prospective IRMS software before settling on a solution.

Therefore, as you search for IRMS software for your organization, you should consider a wide range of factors and attributes that include the following:

Customizability

While the general process of responding to MIRs is relatively standardized, the needs of every medical affairs team are unique. Therefore, it is important that you select IRMS software that can be tailored to align with your team’s structure, objectives, and needs.

The ideal IRMS software or platform for your organization will allow you to customize several aspects of the user experience. Specifically, you should choose a solution that allows you to modify workflows, create custom data fields, and augment the dashboard to provide a more seamless user experience.

User-friendliness

Speaking of the user experience, the best IRMS solutions are exceptionally user-friendly, though it’s important to note that some options out there are clunky, tedious to use, and downright complicated.

If you implement IRMS software that falls in the latter camp, you will experience diminished employee buy-in and a reduced return on your investment.

On the other hand, when your new platform is intuitive and easy to use, your team will experience a shallower learning curve, be more accepting of the software change, and will embrace the tools you provide them with. On a broader scale, adopting user-friendly IRMS software will decrease your time to value and boost your ROI.

Integrations

One of the biggest challenges associated with traditional MIR management is a lack of data visibility. When your medical affairs team uses disparate software to manage its MIRs, visibility is poor, and errors occur far too often.

With that in mind, tearing down data silos and promoting total MIR visibility are both vital if you want to streamline your medical information request management processes, and to achieve those goals, you need an IRMS software solution that seamlessly integrates with your existing technology stack.

Before you commit to a solution, though, make sure it is compatible with your customer relationship management (CRM) software and other database systems, as well as your email and collaboration tools. Such a solution will be able to share vital data with your other systems and empower your staff to optimize productivity.

Compliance

Your IRMS software should also support your compliance efforts. Choose a solution that provides various compliance and governance tools so that you can closely monitor and regulate your medical information request management processes. In particular, you should use IRMS software that features audit trails, permission controls, and a notification system that updates you on the latest regulatory changes so you can ensure adherence.

Reporting and analytics

Implementing an appropriate IRMS software solution and modifying your medical information request processing protocols will help promote compliance and improve efficiency.

However, it is important to closely monitor the efficacy and performance of your MIR processes on an ongoing basis, and selecting an IRMS solution that provides robust reporting and analytics capabilities will help you do exactly that. You can leverage the insights from these reports to identify potential pain points, further promote efficiency, and deliver a frictionless experience for healthcare professionals.

Security

In addition to responding to MIRs in a timely manner, your organization is also tasked with protecting sensitive medical data. Failing to do so can lead to severe reputational damage and hefty civil penalties.

Unfortunately, antiquated MIR management tools, such as shared inboxes and spreadsheets, not only leave the door wide open to security breaches but also increase your exposure to cyber threats.

A modern, cloud-based IRMS solution can support your cybersecurity strategy and help you avoid these challenges. Maximize your security by choosing a platform that offers features such as user authentication, access controls, and encryption, as each of these will help you ensure the confidentiality and integrity of the information you manage.

Transform your MIRs management processes with MIRador

Without the right tools in place, your medical affairs teams will become overwhelmed by the complexity and sheer volume of MIRs that they receive. If your pharmaceutical entity wants to position your teams to succeed while simultaneously promoting compliance, you need IRMS software.

Investing in an IRMS software solution can help you streamline the medical information request management process and unlock other benefits, including:

• Better data management
• Enhanced compliance
• Improved efficiency
• Optimized visibility

However, if you want to get the most out of your investment and expedite time to value, it is critical that you select a solution that is customizable, user-friendly, and robust.

MIRador provides the tools and capabilities your medical affairs team needs to facilitate compliance and optimize overall MIR handling efficiency.

When discussing our IRMS software, a senior pharmaceutical executive had the following to say:

“Every company does MIR differently. Some companies have dedicated medical information teams, while small to midsize companies might not have a dedicated person in that role. Having established best practices and a technological foundation for collecting and processing this information is critical. Any organization that is looking for a medical information solution should consider BP Logix as an option.”

If you would like to learn more about the purpose-built solution that was delivered for this executive, and many other entities in the life sciences space, book a call with BP Logix today.

Medical information requests (MIRs) are a crucial part of the healthcare and life sciences industry, allowing healthcare providers to obtain the information they need to provide the best possible care for their patients. However, without an efficient MIR management process, delays and inaccuracies can jeopardize patient safety, regulatory compliance, and a company's reputation.

In this guide, we'll explain what MIRs are, why they matter, and share best practices for handling them. We'll also cover the benefits of using a centralized management strategy and process automation tools, such as BP Logix's MIR solution, which can alleviate common MIR management challenges and ensure prompt, accurate, and compliant handling.

Whether you're a medical affairs professional, healthcare provider, or pharma executive, this guide will help you navigate the complex world of medical information requests. Already well-versed in MIRs? Skip ahead to MIR management best practices!

Types of medical information requests

MIRs can take many forms:

• Adverse event reporting

• Product information requests

• Medical inquiries

• Clinical study data

• Off-label information

• Product complaints

Let's delve into what these MIR types entail and what role they play in the lives of healthcare providers, patients, and medical affairs teams.

Adverse event reporting

Adverse event reporting is a critical component of medical information requests. In this type of request, healthcare providers submit information about any undesirable or unexpected health events experienced by patients while using a particular medication or medical device. These events could range from mild side effects to severe allergic reactions or even fatalities.

For instance, imagine a patient is prescribed a new medication and then experiences an adverse health event that they suspect is caused by the medication. The healthcare provider would then create an adverse event report to submit to the company that manufactures the medication. This report would contain detailed information about the patient, the medication, and the adverse event experienced.

Pharmaceutical companies must carefully track and promptly respond to all adverse event reports they receive. Failure to do so can have severe consequences, including patient harm, regulatory sanctions, and reputational damage. Effective management of adverse event reporting is essential for maintaining patient safety and ensuring that products remain compliant with regulatory requirements.

Product information requests

Product Information Requests (PIRs) are a common type of MIR that medical affairs teams handle. PIRs seek general information about a product such as its indications, dosages, contraindications, and clinical trial results.

For example, a physician might request PIRs to understand whether a medication would be a suitable option for their patient with a specific condition. Another provider may want more information on a medication than what is listed on the label.

Handling PIRs requires the ability to provide comprehensive information about the product to healthcare providers while ensuring regulatory compliance. It is essential to handle these requests efficiently as they could impact providers’ decision-making process and, ultimately, patient outcomes.

Medical inquiries

Medical inquiries are a specific type of medical information request that requires a detailed response from a medical affairs team. These requests are often initiated by healthcare providers seeking guidance on a specific medical issue or question related to a product.

Let's say a provider inquires about the appropriate dosage for a patient with a specific medical condition, or the potential drug interactions of a product with other medications. As with other types of MIRs, it is important for companies to respond to medical inquiries in a timely and accurate manner to provide healthcare providers with the necessary information to make informed decisions.

Clinical study data

Clinical study data requests are another common type of MIR. Healthcare providers may request access to detailed clinical study data, such as results from clinical trials, to help them make informed decisions about treatment options for their patients.

For instance, a physician may request clinical study data on a new medication before prescribing it to their patient. This request may include information about the drug’s safety, efficacy, and potential side effects.

Handling clinical study data requests requires companies to provide accurate and comprehensive data while adhering to regulatory requirements for data privacy and protection.

Off-label information

Off-label information requests are a specific type of MIR that requires companies to respond to requests for information about the use of a product outside of its approved label indications. These requests could include information about the potential benefits and risks of using a product off-label.

Let's say a healthcare provider inquires about using a medication to treat a condition not listed on its label indications. In these cases, companies must ensure that their responses are accurate and do not promote the off-label use of their product.

Handling off-label information requests requires companies to carefully evaluate the information they provide and ensure that their responses comply with regulatory requirements.

Product complaints

Product complaints are a type of MIR that companies use to collect and address customers' concerns about their products. These complaints can range from product quality to issues with packaging, labeling, or other components of the product.

Imagine a patient files a complaint about a medication they took because they believe it's causing them harm. A company must investigate the complaint thoroughly and respond in a timely manner to address any issues with their product.

Handling product complaints requires companies to have an effective complaint management process in place to investigate and address concerns raised by patients.

Why medical information requests matter

MIRs have a significant impact on providers and patients, as well as medical affairs professionals and the organizations they represent. As such, it is essential for life science companies to establish clear MIR submission protocols and develop an efficient system for processing incoming requests.

While larger companies often have a dedicated team to handle MIRs, smaller organizations may have limited resources and rely on a smaller team to manage these requests. Regardless of the size of the organization, it is crucial to handle MIRs efficiently and respond to them promptly in order to:

• Ensure regulatory compliance

• Keep patients safe

• Manage company reputation

• Maintain competitive advantage

• Continuously improve

Let's take a closer look at why mastering medical information request management is vital in these areas:

Regulatory compliance

Pharmaceutical and medical device companies have a legal obligation to provide timely, accurate information about their products to the general public, patients, and healthcare professionals. Failure to comply can result in severe consequences, including legal actions, fines, and damage to your company's reputation.

The Food and Drug Administration (FDA) mandates this reporting and outlines pharmaceutical companies' responsibilities in its authoritative guide, “Responding to Unsolicited Requests for Off-Label Information About Prescription Drugs and Medical Devices.”

Under these guidelines, pharmaceutical companies must respond truthfully to unsolicited medical information requests. Misleading information and off-label promotion of product uses are prohibited in these responses, and the company must maintain detailed records of all MIRs and their responses.

Regulatory requirements for MIRs are becoming increasingly stringent. Non-compliant organizations risk penalties and other punitive measures. By ensuring regulatory compliance, you protect your business continuity and profitability.

Patient safety

Prompt and accurate responses to medical information requests are crucial to ensuring patient safety. When healthcare providers have access to the information they need about medications and devices, they can make informed decisions that promote positive health outcomes.

However, when pharmaceutical companies are slow to respond to MIRs, patient safety can be compromised. Providers may be hesitant to prescribe a particular medication, potentially resulting in delayed or inadequate treatment for patients.

MIRs also provide healthcare providers with a way to report concerns or adverse events, which pharmaceutical companies can use to improve products and protect patients from the risks associated with faulty devices or medications. By prioritizing the efficient management of MIRs, companies can maintain a strong focus on patient safety and improve overall healthcare outcomes.

Reputation management

In today's age of social media and online reviews, negative news can spread rapidly, potentially harming a pharmaceutical company's reputation. To stay ahead of any rumors or concerns, it's crucial to respond quickly and effectively to medical information requests.

Swift, accurate responses to MIRs can help put out any potential fires before they spread too far. This proactive approach can help maintain public trust and protect a company's reputation from the fallout of adverse events.

On the other hand, slow or inaccurate responses can have the opposite effect, damaging public trust and causing patients to seek out competitor products. Mishandling MIRs can ultimately lead to decreased product usage and revenue loss.

Competitive advantage

In the fiercely competitive industry of life sciences, companies must go the extra mile to maintain an edge over their rivals. Responding to medical information requests promptly is an excellent way for companies to gain a competitive advantage.

A streamlined MIR process shows healthcare providers that a company is transparent, trustworthy, and patient-focused. These factors are crucial in building long-term trust and relationships with providers and patients.

By developing an efficient MIR process, pharmaceutical companies can help providers make informed decisions about prescribing their products. This proactive approach can alleviate prescription hesitancy and increase the likelihood of a provider choosing their product over a competitor's.

Ultimately, having an efficient and effective MIR process can set a company apart from its rivals and contribute to its long-term success.

Continuous improvement

In order to provide better outcomes for patients, life science organizations must be able to stay ahead of the curve. This is another area in which MIRs shine — they can provide valuable insights that may help companies innovate and drive continuous improvement in their products.

For example, imagine there is a medication indicated for pain relief that could also help patients overcome sleep issues. By bringing this information to organizational decision-makers, the company could obtain funding to explore other uses for the medication — ultimately helping them stay competitive in the market, generate more revenue, and improve patient outcomes.

Best practices for handling medical information requests

Managing medical information requests can be challenging, but life science companies can simplify the process and promote transparency by following a few established best practices.

Specifically, organizations tasked with handling medical information requests should:

1. Develop a clear, standardized process

The first step to mastering medical information request management is developing a clear and standardized process.

A well-designed process will act as a blueprint for the medical information team to follow and should cover the intake, response, tracking, and record-keeping aspects of MIR. It should also align with FDA guidelines to guarantee compliance and prevent any monetary repercussions.

Without a clear process to follow, the medical information team may miss key steps in the process, leading to delays in responding to requests, inaccurate information, and even noncompliance with FDA regulations. Inconsistent processes can also lead to confusion among team members, making it difficult to track and manage requests efficiently. A standardized process is essential for ensuring that all medical information requests are handled promptly, accurately, and in compliance with regulations.

To create a robust and comprehensive process, it's essential for decision-makers to gather feedback and input from the people who are most familiar with the day-to-day management of medical information requests. This feedback can help ensure that the process is clear, comprehensive, and easy to follow for all team members. The end result is a well-designed process that meets the needs of the organization while also ensuring compliance and efficiency in managing MIRs.

2. Create a dedicated medical information team

All organizations, regardless of size, should establish a dedicated medical information team to manage MIRs. This will ensure that requests are promptly and efficiently processed, and nothing falls through the cracks. If responsibilities are delegated to other teams, such as sales or marketing, it can lead to delayed responses, compliance issues, and damage to a company's reputation.

Creating a dedicated MIR team will require effort, but the benefits will be worthwhile. This team will be better equipped to handle requests, maintain compliance, and ensure that information is communicated transparently.

While some smaller companies may not have the resources to create a dedicated medical information team, there are ways to overcome this challenge and still manage MIRs effectively.

One option is to assign MIR responsibilities to a small group of individuals within the organization who have transferrable expertise and knowledge to handle these responsibilities.

Another option is to harness process automation to help streamline MIR management and reduce the need for a large team. Automated systems can be used to track and manage requests, respond to routine inquiries, and flag urgent requests for immediate attention. This can help smaller organizations manage MIRs more efficiently while maintaining compliance and ensuring prompt responses to healthcare professionals.

3. Use a centralized system to manage MIRs

Managing medical information requests through email or shared files can be risky and cause unnecessary confusion. Without a centralized system to manage MIRs, time-sensitive requests can get lost or overlooked, leading to delayed responses and a risk of noncompliance. This can cause friction among healthcare providers and ultimately damage the organization's reputation.

Additionally, managing MIRs without a standardized process can create confusion among team members about their roles and responsibilities, leading to inconsistent responses and inaccurate information being disseminated to healthcare providers.

Implementing a centralized system to manage MIRs will simplify the process, prevent any mishaps, and ensure that all requests are responded to promptly. Storing MIR data in a single location will help the MIR team leader oversee the management of requests and verify that the team responds to them appropriately based on their priority and urgency.

4. Implement a prioritization system

Pharmaceutical companies should prioritize MIRs to ensure that urgent requests are handled before routine inquiries. Developing a prioritization system will help the medical information team manage their workload and address requests based on their urgency.

For instance, consider a medical information team that receives two MIRs on the same day: one is a routine inquiry about dosage information, while the other reports a potential adverse event associated with one of the company's products. In this scenario, the team should prioritize the adverse event MIR, addressing it promptly to mitigate potential risks to patient safety. MIRs that are of equal urgency should be handled based on the order they are received.

Having a clear prioritization system in place ensures that the team is efficiently managing their workload while addressing the most pressing issues first.

5. Monitor MIR response performance

Want to ensure that your medical information request management program is continuously improving? Consider monitoring the the performance of your organization's MIR responses. You can gain valuable insights to make data-driven decisions by tracking metrics like response times, request volumes, and other relevant data points.

For example, let's say a pharmaceutical company notices an increasing trend of requests regarding potential off-label uses of their product. By monitoring this trend and analyzing the data, the company can conduct further research into the potential off-label uses, test the product's efficacy in those areas, and potentially apply for FDA approval for new indications.

This type of data-driven decision-making leads to product innovation, new opportunities in the market, and increased revenue.

On the other hand, neglecting to monitor MIR response performance could lead to missed opportunities for growth and potential noncompliance with regulatory requirements. For example, let's say a pharmaceutical company receives an MIR regarding the use of their product in a specific patient population. Monitoring MIRs may help the company identify potential gaps in how they are labeling or indicating their product. Failing to address these gaps puts the company at risk for being noncompliant with FDA regulations, resulting in fines, penalties, and PR nightmares.

By monitoring MIR response performance, companies can avoid regulatory issues and protect their reputation from negative PR. The insights gained from monitoring response performance can also help companies continuously improve their MIR process as a whole by allocating resources more effectively and going the extra mile to meet the needs of healthcare providers and their patients.

Automating your centralized MIR system

Implementing the best practices and centralizing your MIR system is essential for compliance and efficient management of medical information requests. However, not all centralized systems are equal, and rudimentary ones such as shared email inboxes lack the tools and management capabilities necessary to ensure compliance.

To meet FDA requirements for adverse event handling and auditing, it's crucial to route inquiries to the appropriate team members. Failing to do so can result in difficulty obtaining treatment approvals and even revocation of previously approved treatments, as demonstrated by the cases of chloroquine phosphate and hydroxychloroquine sulfate.

To ensure compliance and efficient MIR management, consider implementing a powerful management system that includes sophisticated process automation tools. Leveraging tools such as BP Logix’s MIR solution enables you to tap into the power of predictive analytics, facilitate centralized data management, automate workflows, and integrate your database with existing systems.

Process automation tools not only streamline your MIR system but also reduce manual errors, speed up response times, and enable proactive management of requests, leading to a more efficient and compliant system.

Optimize MIR management with BP Logix

Medical information requests are a critical aspect of the healthcare industry, with the potential to influence patient outcomes, regulatory compliance, and revenue generation. As such, it's imperative to have a robust and streamlined process in place to manage them effectively.

By embracing process automation and optimization tools, you can revolutionize your approach to MIRs and achieve a more efficient and compliant management system. With BP Logix's MIR solution, you can leverage cutting-edge predictive analytics, centralized data management, and customizable workflow automation to streamline your MIR process and reduce the risk of errors and compliance issues.

Our advanced platform also enables seamless integration with existing systems and workflows, making it easy to adopt and implement into your existing infrastructure.

With BP Logix's MIR solution, you can ensure that your organization is equipped to manage MIRs effectively, promote compliance, and protect your reputation in the healthcare industry. Contact us today to learn more and take the first step towards optimizing your MIR management process.