Recent posts about publication management

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.

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.

Medical affairs leaders are ready to cut through the buzz and finally get a clear answer to “what can AI actually do for us?”

I’m Alex Reinthal, and as Vice President of Product at BP Logix, I have a unique vantage point on how AI and machine learning technologies will develop in life sciences software.

In this article, I will share my insights into the future of generative AI and machine learning. I’ll also delve into practical examples of these technologies through demonstrations of an upcoming prototype that is currently in the works for our publication management solution, PubPro.

What I'm hearing from life science leaders 

Medical affairs leaders are eager to “be the change” in their organization alongside the R&D and commercial pillars of their organizations. Part of that means being ready to embrace new technologies that can take their work to the next level. 

That's why, with the recent flurry of excitement surrounding the potential of AI to transform the life sciences industry, it’s not surprising to see many medical affairs leaders keeping their ear to the ground to determine their next steps.

"I want AI to do the work so my team can focus on strategy."
- Life sciences leader at MAPS 2024 

Discussions about how best to harness this technology, however, tend to lean theoretical. With so many buzzwords and vague aspirations floating around, conceptualizing practical applications of AI and quantifying their impact is proving to be a real challenge for medical affairs leaders. 

There is clearly enthusiasm for adopting AI-powered solutions, but medical affairs leaders need more to go on than just buzzy jargon. They need a clear answer from software vendors on how artificial intelligence will: 

1. Make their day-to-day lives easier

2. Accelerate processes and time-to-market

Practical applications of machine learning and generative AI 

At BP Logix, we view investing in AI/ML as the logical next step for workflow automation technology. As we plan out the product roadmap for PubPro, we're making sure that medical affairs teams can fully leverage AI/ML capabilities.

And what exactly do these capabilities entail? I will lay out exactly what we’re working on and explain how it’s going to simplify and speed up your publication management processes.

Machine learning

First up, let’s talk machine learning. Machine learning is a subset of AI that enables systems to learn and improve from experience without being explicitly programmed. With its ability to analyze patterns and predict outcomes, machine learning is an incredibly powerful component of process automation that helps you continuously improve efficiency and accuracy in your day-to-day work.

Advanced machine learning already exists in PubPro — it’s an integral component and administrative feature of Process Director for Life Sciences, the scientific communication platform that PubPro is built on. To build upon the product’s AI/ML features already available to administrators, we’re in the process of making these analytic tools and insights more accessible and usable to everyday users of PubPro.

Through our planned enhancements, users will be able to look at how their processes are performing at a high level, easily identify bottlenecks, and optimize their workflows based on analytics.

Generative AI

Generative AI, distinct from machine learning, refers to AI that can generate new content, from text to images, based on the data it has been trained on.

At BP Logix, we want to use generative AI to help PubPro users find the information they need more easily — and with fewer clicks.

We’re starting with Pathfinder, a LLM-powered AI assistant designed to help users with all things PubPro. Here are three examples of Pathfinder capabilities that will make life easier for PubPro users and speed up publication processes.

1. Analytical capabilities

With Pathfinder, PubPro users will be able to perform conversational searches to quickly generate summaries or detailed analyses of specific publications.

If a user requests an executive summary for a publication, Pathfinder will provide concise, relevant insights instantly that aid the user in strategic decision-making.

Video description: On the PubPro dashboard, the user opens up the Pathfinder chatbot and types in a request for an executive summary of a specific publication (via Pub ID number). Pathfinder conducts a literature analysis and generates an executive summary of this publication. Pathfinder asks the user if they would like to copy the executive summary to their clipboard, and the user says yes. This demonstrates Pathfinder’s ability to perform conversational searches, conduct literature analyses, and generate executive summaries of publications with a LLM integration.

2. Competitive research capabilities 

Pathfinder will enhance competitive research in PubPro by enabling users to efficiently query and gather specific market intelligence.

For example, if a user asks for a list of drugs in phase 3 trials for a particular condition, Pathfinder will deliver up-to-date, comprehensive data via an integration with clinicaltrials.gov.

This functionality will not only save time — it will provide a strategic advantage for medical affairs teams that want to maintain their understanding of the competitive landscape.

Video description: On the PubPro dashboard, the user opens up the Pathfinder chatbot and types in the request to aid them in competitive research. Specifically, the user asks Pathfinder to list all drugs treating ulcerative colitis currently in phase 3 trials with their study and study completion date. Pathfinder responds with four drugs that meet the user’s criteria, along with the study info and completion date. This demonstrates Pathfinder’s ability to source data about publications and journals/congresses.

3. System documentation capabilities

With Pathfinder’s ability to reference software documentation, users can ask questions about how to accomplish certain tasks within PubPro and get immediate answers.

To make this feature even more useful, our product roadmap includes plans to eventually equip Pathfinder with the power to navigate users, at their request, to key screens related to their query.

For example, if a PubPro user asks how to adjust due dates for expedited reviews, Pathfinder could not only explain how to make these changes — it could seamlessly redirect the user to the appropriate configuration menu screen to begin carrying out that task.

Video description: On the PubPro dashboard, the user opens up the Pathfinder chatbot and asks how to change due dates for expedited reviews within PubPro. Pathfinder references PubPro system documentation and responds that the setting for expedited review due dates can be found in PubPro’s System Configuration menu page. Pathfinder then asks if the user would like to navigate directly to this page. The user says yes, and then Pathfinder navigates the user to that page.

Looking to the future: Our long-term plans for generative AI

While we already have some exciting AI tools in the works for PubPro, we’re also thinking ahead to what’s next.

One use of generative AI that we’re envisioning for later down the road involves PubPro’s collaborative document editor. We want Pathfinder to help users catch errors and make suggestions for improvement. And we’re not just talking about spell check here. Eventually we could have Pathfinder checking for accuracy on a content substance level. Essentially, AI will provide you with an additional layer of review beyond manual reviewers.

For example, users could have Pathfinder review studies that they're pulling into PubPro and provide feedback. For example, Pathfinder might provide feedback like “When you look at what publications get cited the most, they have ABC characteristics in common. So, you should consider doing XYZ to your publication to make it more effective.”

Over time, this functionality will only get better and better at making sure that your publications are accurate and align with your study information.

Learn more about PubPro

Ready to see our powerful publication management software in action? Contact our team to request a free trial of PubPro.

An efficient publication management process is critical for medical affairs teams tasked with bringing a drug to market. Yet, many companies continue to rely on decentralized tools like Excel and Outlook to manage key aspects of this process. While these familiar tools might seem low-risk and affordable, they come with practical challenges that can hinder growth and compliance risks that could result in delays or penalties.

Explore the strategic dangers and day-to-day hurdles of manual publication management and learn why automation is the key to unlocking growth, innovation, and compliance in the life sciences industry.

Strategic risks of manual publication management tools

Clinging to outdated manual tools for publication management in the fast-paced life sciences industry isn't just a matter of convenience – it carries several profound strategic risks:

1. Cost escalation

Inefficiencies and errors caused by manual processes can lead to higher operational costs due to increased labor hours and rework, not to mention potential fines stemming from compliance violations. The company may also need to invest in additional resources to manage the growing complexity of the publication process.

2. Missed opportunities

Inaccurate or delayed publication submissions can lead to missed opportunities to present research at conferences, submit articles to prestigious journals, or engage with key stakeholders. These missed opportunities can impact the company's visibility, influence, and ability to drive innovation.

3. Delayed time-to-market

Inefficiencies in the publication management process can lead to delays in getting research findings published. These delays can slow the dissemination of critical information to the medical community, regulatory bodies, and other stakeholders, potentially slowing down the development and adoption of new drugs or treatments.

A study by the University of Texas at Austin found that drug approval delays can cost life science companies an average of $1 million in revenue for each day a drug remains in limbo.

4. Reputation damage

Inaccurate or delayed publications, compliance issues, and inefficiencies can tarnish the company's reputation within the industry and among peers, potential partners, investors, and patients. A damaged reputation can undermine the scientific credibility and impact of the company's work, as well as impact the company's ability to secure future funding, partnerships, and collaborations.

Tactical obstacles of manual publication management tools

These strategic risks don't exist in a vacuum; they stem from the tangible issues faced during the daily grind. Let's explore how the practical, day-to-day obstacles inherent in manual publication management tools create and amplify these strategic risks.

1. Manual data entry 

The life sciences industry thrives on precision, accuracy, and timely dissemination of critical information. However, when manual data entry becomes the linchpin of your publication management process, you introduce an element of uncertainty and inefficiency that can have far-reaching consequences.

Why is manual data entry bad news for publication management? There are two key reasons:

• Increases risk of error: Manual data entry and copying and pasting between tools increase the risk of errors. Even small mistakes in data entry can have serious consequences when it comes to the accuracy of publications.
• Poor use of resources: Manual processes and tools are resource-intensive and consume valuable time and labor. Rather than research professionals spending excessive time on time-consuming administrative tasks (such as entering data into Excel spreadsheets or manually consolidating review feedback from multiple reviewers), this time could be better spent focusing on higher-value research tasks such as analyzing data, strategizing, and contributing to the content itself.

LimFlow, an early-stage life sciences company specializing in treatments of critical limb-threatening ischemia (CLTI), was grappling with just this very challenge.

"If we had ten reviewers providing feedback on a single publication, that meant there were ten versions of the publication that needed to be reconciled," LimFlow's Director of Medical Affairs explains. "Manually combing through each version and reconciling all the feedback into one cohesive document requires a lot of time and effort on our part."

To solve this problem, LimFlow implemented PubPro, a publication management system that enabled multiple reviewers to work on the same document simultaneously.

2. Lackluster process visibility

Process visibility is vital at all levels of the medical affairs department — from the tactical day-to-day level of managing the back-and-forth of publication review to the bird's eye 10,000-foot view that provides leaders with insights and data to make informed strategic decisions.

Let's dive into the hallmarks and risks of a publication management process that lacks visibility:

• No automated workflow routing: Reviewing and approving publications often involve multiple rounds of feedback and revisions. Manual tools lack automated workflows for routing documents to the right stakeholders, resulting in delays and potential oversights in the review process.
• Rudimentary or non-existent version control: Managing versions of documents becomes challenging without a centralized system to track changes and maintain version history.
• Creates data silos: Manual tools are often isolated from other systems used within the organization, leading to data silos and duplication of efforts. Information can be scattered across different files, folders, and email threads. These data silos make it difficult to keep track of important details such as publication status, deadlines, and author contributions.
• Limited process insights: Managers and stakeholders need visibility into the publication pipeline to make informed decisions and allocate resources effectively. Manual tools offer limited reporting and analytics capabilities, making it difficult to assess the progress of different publications.
• Limited scalability: As a life sciences company grows and handles more publications, the limitations of manual tools become more pronounced. Managing a larger volume of publications with manual tools becomes increasingly challenging and inefficient. 

3. No auditing features

Compliance is king in highly regulated industries like life sciences. Publication management processes that lack auditing capabilities pose serious risks:

• Compliance violations: Regulatory bodies such as the FDA have strict guidelines for publication and data reporting. Non-compliance with regulatory requirements, industry standards, and internal processes can result in serious legal and financial consequences. Excel and Outlook do not provide the necessary security measures and audit trails to ensure compliance with industry regulations.
• Data security risks: Decentralized tools lack the security measures of dedicated software solutions, increasing the risk of data breaches and loss of sensitive research data.

Why automated publication management solutions matter

While Excel and Outlook have their uses, relying on them for complex publication management in the life sciences industry is a recipe for setbacks and missed opportunities. The practical challenges of version control, auditing, data entry, process visibility, and workflow routing all have tangible impacts that can result in cost escalations, missed opportunities, delayed time-to-market, and reputation damage.

To overcome these challenges and reduce business risks, life sciences companies should ditch the use of manual, decentralized tools and invest in a dedicated publication management software solution such as PubPro.

PubPro is an automated publication management system equipped with outstanding version control, robust auditing features, automated workflows, and analytic tools that offer several key benefits:

• Enhanced efficiency: Streamlined workflows and reduced data entry tasks free up time for high-value activities, accelerating publication timelines.
• Error reduction: Automated data entry and version control mitigate human error, ensuring accurate and reliable publications.
• Seamless collaboration: Dedicated software fosters smooth collaboration, allowing stakeholders to access, review, and contribute to publications in a centralized environment.
• Risk mitigation: Compliance features and alerts ensure adherence to industry regulations, minimizing the risk of fines and reputational damage.
• Resource optimization: By automating manual tasks, companies can reallocate resources to research, development, and innovation.

From Excel to excellence

By embracing the power of specialized software solutions like PubPro, life sciences organizations can not only streamline their publication management processes but also advance scientific knowledge and improve patient outcomes.

Request a demo of PubPro today. 

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.

One-size-fits-all solutions don't work when it comes to publication management software.

That's why PubPro from BP Logix offers organizations unparalleled configurability. Built on our low-code Process Director for Life Sciences platform, 80% of the solution already built and the remaining 20% configured within days to your company's specific requirements.

Here are four recent improvements we’ve rolled out on PubPro that make it easier than ever to configure and use the solution according to your organization's SOPs.

1. Automated reviewer assignments

PubPro's automated reviewer assignments feature makes it easy to ensure that the right people review your publications.

When authors submit new publications, PubPro automatically assigns the appropriate reviewer based on criteria such as subject matter expertise or workload.

These automated reviewer assignments help streamline the review process and ensure that publications are always in the right hands.

2. Updated user interface

PubPro's new look is sleek and user-friendly. Our updated interface is more intuitive and straightforward to use than ever, ensuring your team can easily navigate the system and complete tasks efficiently.

3. Role-specific dashboards

PubPro's role-specific dashboards allow users to quickly see the tasks and activities most relevant to their role.

Whether the user is an author, reviewer, or administrator, PubPro's dashboard is tailored to their specific function. For example, here's a peek at a reviewer's dashboard and workflow:

4. Variable user deadline settings

With PubPro, you can configure different turnaround times for reviewers based on your publication's unique requirements. This ensures that everyone works according to the same deadlines and that your publication stays on track.

Don't settle for "one size fits all"

Configurability is vital when it comes to choosing publication management software.

PubPro allows your organization to easily tailor processes to meet specific needs, from automated reviewer assignments to variable user deadline settings.

Contact us today to learn how PubPro can level up your publications team.

A medical affairs leader at LimFlow explains why they turned to BP Logix for a powerful publication management solution that delivers the same core functionality as competitors at a more cost-effective price point.

When I stepped into a leadership role at an early-stage life science company, I knew I’d wear many hats. I also knew I’d need to be strategic about where I devote my energy if I wanted to stay focused on the big picture.

Finding technology that speeds up the more time-consuming parts of my job was a priority for me because it would help LimFlow bring our life-changing therapy to patients and providers faster.

At LimFlow, we’re dedicated to improving the lives of patients suffering from critical limb-threatening ischemia (CLTI). This severe form of peripheral arterial disease (PAD) restricts blood flow to the legs, feet, and toes, which can lead to tissue damage and even amputation.

The LimFlow System is a minimally invasive procedure that improves blood flow by creating a bypass around blocked arteries. Our unique approach to treating this debilitating condition offers new hope to those who have been told amputation is their only option.

One of my top priorities as a medical affairs leader at LimFlow is to ramp up our publications and build out our department. However, we faced significant challenges with our publication management process that hindered our ability to achieve these goals. As a smaller company, we struggled to find an affordable and accessible solution for automating our publication management process.

Here's how we’re overcoming those challenges by partnering with BP Logix.

Our publication review challenge

One of the biggest challenges of our publication review process was how much time we had to spend managing feedback from multiple reviewers. If we had ten reviewers providing feedback on a single publication, that meant there were ten versions of the publication that needed to be reconciled.

Manually combing through each version and reconciling all the feedback into one cohesive document requires a lot of time and effort on our part, and it increased the chances of errors creeping into the process.

To make matters worse, we were relying on email exchanges to facilitate the entire review process, which resulted in a lot of inefficient back-and-forth communication between the reviewers and our team.

Pouring so much time and manual effort into managing publication reviews meant pulling my attention away from other opportunities for growing the company, building our brand, and establishing a reputation within the industry. Overall, our publications were taking longer to produce, and we couldn't share important research as quickly as we would have liked.

To ensure our new medical affairs department can keep pace with the company’s growth goals, I knew we’d need to find a publication management solution that could free our team from tedious, time-consuming busy work.

Evaluating solutions

During our search for a publication management solution, we initially considered Pubstrat, a well-known option in the industry. However, after reviewing the pricing, it became clear that it was not feasible for our budget.

That’s when we decided to take a closer look at PubPro from BP Logix.

While larger companies with bigger budgets might be able to justify the cost of solutions like Pubstrat, we found that PubPro offered the same basic functionality at a much more reasonable price point — making it an excellent fit for the needs of a smaller, early-stage company like ours.

What really stood out to us during the evaluation and sales process was the BP Logix team's willingness to accommodate our needs. They worked with us to develop a solution that fit within our budget while still meeting our functionality needs. We appreciated the level of personalized attention we received. It was clear that BP Logix was invested in helping us succeed.

Implementing PubPro

Working with BP Logix has been an incredibly positive experience so far. They have made implementation a smooth, seamless process, working with us every step of the way to ensure that the solution meets our needs.

The functionality we're most excited about are the collaborative document authoring tools. We expect this to be a game-changer for us, as it will streamline the publication review process and reduce the amount of manual effort required to reconcile multiple reviewers’ feedback.

With the ability to have multiple reviewers working on the same document simultaneously, our medical affairs team will be able to save so much time:

While PubPro is a newer product, we're excited about the potential for future features and capabilities. We know that BP Logix is invested in listening to customer feedback and using it to shape the product roadmap.

We look forward to the continued development of PubPro, and we're confident that it will be a valuable asset for our team as we continue to grow and develop our medical affairs department.

Pharmaceutical organizations must constantly evolve in order to stay competitive in the market and compliant with regulations.

Recent years have seen significant change in the role of medical affairs teams in the pharmaceutical industry. COVID-19 accelerated these changes. As a result, many medical affairs departments now face a pressing need to meet shifting expectations.

Technology is in a unique position to alleviate some of the growing pains that medical affairs teams experience as they take on greater responsibilities. Process automation, in particular, can play a valuable role in streamlining and improving the efficiency of medical affairs workflows.

With process automation solutions, medical affairs leaders can:

• Deliver actionable insights to key decision makers
• Reduce administrative overhead to enable team members to spend more time on stakeholder engagement
• Digitally engage HCP’s and KOL’s increasing the capacity of the team to engage these key stakeholders
• Streamline collaboration across departments to speed up the new drug development
• Contain costs, by introducing new efficiencies

The role of process automation is becoming more critical as the field of medical affairs continues to grow. In this article, we’ll walk through why and how medical affairs is changing (including the role played by the COVID-19 pandemic), and dive deep into how technology must adapt to meet the needs of this growing sector.

How medical affairs is changing

Historically, medical affairs provided support to the research and commercial pillars of pharmaceutical and medical device companies, but that's changed drastically over the past decade.

These organizations are faced with increasing regulatory pressures, rising drug development costs, and a faster-paced competitive market. To meet the increasing market demands, medical affairs departments are facing greater expectations and workloads without a proportionate increase in budgets. 

To address this challenge, companies are turning to process automation solutions to help medical affairs teams do more with less. By automating routine tasks and optimizing resource utilization, medical affairs teams can focus on delivering high-quality, credible information to physicians and patients in a timely and efficient manner.

Medical affairs is brought to the table earlier in the drug development process to foster more seamless collaboration with other departments and contribute to strategic decision-making.

COVID-19's impact on medical affairs

The changes to the medical affairs industry have been in the works for the past decade, but the COVID-19 pandemic galvanized the situation further by rewriting the script on (a) how pharma develops and brings drugs to market, and (b) how the HCP/MSL engagement model functions.

Developing and bringing drugs to market

When we talk about how the pandemic changed the way drugs are developed and brought to market, there’s no way not to mention the impact that Operation Warp Speed (OWS) had on the time-to-market speed for pharmaceutical products.

OWS was initiated by the United States government in spring 2020 to help accelerate the development and distribution of testing, vaccines, and therapies for COVID-19.

In addition to saving millions of lives and helping gain better control over the pandemic, the operation demonstrated that it was possible to move pharmaceutical products through the development and approval process much faster than previously thought.

Of course, developing a vaccine to combat an active pandemic is a unique situation. Most drugs do not warrant emergency use authorization, nor are they backed by the whopping $10 billion budget granted to Operation Warp Speed by the CARES act.

Even so, it’s an incredibly valuable case study for medical affairs teams and their colleagues to consider in medical planning. The process for developing and approving drugs often takes between 10-15 years. Imagine a pharmaceutical market that reduces that timeline estimate by half.

That's not only a game changer for patients – it's a competitive advantage for businesses in the pharmaceutical industry.

While the conditions for developing drugs under a pandemic are not replicable for most other drugs, investment in automation technology can emulate some of these fast-paced outcomes. Upgrading medical affairs software with automated solution can not only help teams move faster and more efficiently, but they also provide a better experience for users.

Shifts in the HCP/MSL engagement model

The first year of the pandemic marked a significant increase in digital engagement interactions between healthcare providers (HCPs) and medical science liaisons (MSLs).

Due to pandemic-related travel restrictions, MSLs were now conducting the vast majority (or in some cases, all) of their work remotely.

This new mode of working meant that they could easily engage with multiple HCPs in a single day.

But how did HCPs feel about this change?

According to a June 2020 EU5 report, 55 percent of HCPs said they preferred transitioning to virtual engagements with MSLs. However, only 30 percent of HCPs expressed satisfaction with the quality and value of these digital interactions.

These stats illustrate that the demand for digital MSL engagements is there, but there is still work to be done to ensure these experiences are useful for HCPs.

In the white paper, “Beyond the Field: Evolving Field Medical Engagement and Talent for the Future,” the Medical Affairs Professional Society (MAPS) suggests that the increase in digital MSL engagement presents a golden opportunity for the medical affairs industry to take steps to improve their processes:

“The move to virtual conferences and meetings, where data is not consumed in real-time, has highlighted an opportunity for the industry to revisit compliance, review and approval processes to keep pace with information needs. The timing and consumption of information changes significantly when it’s available online for a clinician to download at their convenience. […] This amplifies the need for the accurate and accelerated review/approval of materials to accommodate the speed that data is consumed virtually.”

The most effective way for pharmaceutical organizations to grasp this opportunity and satisfy the needs of KOLs is to prioritize technology investments that can improve the quality of digital engagements.

Oversight and compliance challenges 

Another critical way medical affairs is changing comes down to compliance and oversight. As scientists and pharmaceutical leaders seek innovative treatments as quickly and safely as possible, the regulatory environment grows more complex by the day.

A significant reason for this complexity has been the outgrowth of pharma applications to more technical, niched scientific areas. Today, pharmaceutical companies are making important advancements in the realms of biologics, mRNA technologies, gene therapies, and more.

These advancements necessitate greater scientific rigor and oversight for medical affairs processes across the board – which is important for safety and validation, as well as for ensuring the sponsoring organization can remain competitive and reduce their legal risk.

The challenge is that as regulations grow more robust and complex, an organization’s SOPs must evolve to meet those requirements. This is another area in which technology must play a critical role.

Investing in purpose-built technology can lessen the challenge of updating SOPs to match the complexities of the moment, as well as help teams work faster because automation makes it easier to meet compliance requirements and check for debarments.

Medical affairs technology needs are also changing

In addition to the impact of COVID-19 and the pharmaceutical industry’s ever-changing regulatory requirements, medical affairs faces greater pressure to provide better customer experiences (CX) and user experiences (UX) to physicians, payers, regulators, journals, and congresses that must access and review drug information digitally.

There are a variety of different tools and technologies that medical affairs professionals can use to improve efficiency and productivity both within their organization and outside of it. These technologies range from custom applications to licensed outsourced solutions, but choosing the right ones is not always simple.

Pharmaceutical companies face three main challenges when researching and selecting technologies:

1. Identifying functionality that can evolve with them

With how quickly medical affairs teams are growing and changing, it’s imperative that the technology they use can evolve with them. That is why any technological solutions under consideration should:

• Meet the emerging needs of the medical affairs professionals.
• Offer the flexibility to customize solutions within its architecture.

For example, in our discussions with medical affairs leaders about their publication planning systems, one of their primary motivations for seeking out a new technology is frustration with the functionality of their existing solutions, including out of date user interfaces, failure to keep up with changing business or regulatory requirements, and insufficient customer support. These incumbent solutions are often longstanding in the industry but have grown complacent, neglecting to prioritize innovative improvements.

As the role of medical affairs grows more complex and wider in scope, these mission critical teams are chafing against the confines of technology that can no longer meet their needs and expectations.

That is why our team of process automation experts created a new publication planning solution, PubPro.

PubPro is designed to improve the speed and efficiency of publication planning processes for medical affairs and medical communications teams. Customers can reduce their publication planning costs by as much as 50%, in addition to solving high stakes compliance issues.

2. Overcoming the perceived burden of switching technologies

Another major hurdle to overcome involves all the perceived barriers associated with switching technologies.

When an organization has used the same system for managing a process for many years, it can feel daunting to make a switch to a new solution. Even if the new solution promises outstanding improvements in efficiency, accuracy, and user experience, organizations may feel tethered to their existing systems and processes for "sunk cost” reasons or they may rationalize that it’s simply “not the right time to shake things up.”

There may also be concerns about the transition itself. Will the implementation and training period cause disruptions to critical projects? How difficult will it be to migrate from the old system? How challenging will it be to train employees on the new system?

The fact is, medical affairs leaders do not have the luxury of taking their time to onboard software slowly, which is why technology partners must prioritize delivering a fast and seamless transition to their customers.

3. Ensuring seamless integration with existing technology

One of the functions of a medical affairs team is to help connect various departments at their organization with external stakeholders, such a HCPs, KOLs, and patients.

In order for medical affairs teams to work effectively, the organization's data must be able to move seamlessly across departmental and organizational boundaries while maintaining privacy and compliance standards.

That is why it is imperative that technology buyers at these organizations ensure they are making investments that can easily integrate with existing tools and legacy systems. The end result should be a streamlined, cross-functional workflow that provides clear visibility into any bottlenecks.

The ideal choice of technology to meet these needs should provide multiple options to enable single sign-on and multiple formats for exchange with the existing technology platforms.

Maximizing competitive advantages

With how rapidly the medical affairs landscape is changing, it’s important for pharmaceutical leaders to bring in technologies that can match the gait of this fast-paced growth and be ready to adapt quickly to new developments and requirements.

Ready to level up your medical affairs team? Contact our team of process automation experts to learn more about implementing one of our process automation solutions at your organization.

With all the hard work that goes into the complex and delicate process of medical innovation, the last thing pharmaceutical and biotech companies want is to see publications delayed by an incomplete or unnecessarily lengthy debarment check process.

The good news is that new technologies can now automate and introduce new efficiencies into checking for debarments. 

Let’s dive into a comprehensive refresh about what debarment checks are, how they work, and how to work them into your pharmaceutical publication processes so that you can more readily identify the advantages of refreshing your company's approach to this regulatory responsibility.

What is an FDA debarment?

In regulatory terms, a debarment is when an individual, organization, or any affiliates are excluded from conducting business with a federal agency.

In the case of the Food and Drug Administration (FDA), there are two types of debarments that apply to the development, approval, or regulation of food and pharmaceutical products:

• Mandatory debarments are the result of a felony conviction for the individual in question. These debarments are typically permanent.
• Permissive debarments usually result from an individual's misdemeanor conviction or a conviction of accessory or conspiracy charges. Corporations can also be debarred for a period of time for direct or indirect violations of FDA law. Permissive debarments can last up to several years.

The FDA maintains a list of individuals who have been convicted of felonies (permanent debarment) and misdemeanors (permissive debarment) related to the development, approval, or regulation of a pharmaceutical product.

What are the business risks of collaborating with debarred individuals?

Working with debarred individuals or entities could have serious ramifications on the development of pharmaceutical products. For example, if a debarred individual is found to have contributed on the planning or development of a new pharmaceutical drug or device, the company and team associated with the project could face fines, delays, and potentially even the temporary debarment of organizations that have neglected to terminate debarred individuals in their employ.

Failure to identify the engagement of debarred individuals or entities can have serious repercussions on the publication and on the company at large. Fines can reach levels of $250K per debarred individual or $1M per organization.

Consider how the failure to screen for or terminate a debarred person would impact your competitive edge in the market. Years of hard work and investment could be jeopardized by a few bad faith collaborators.

With so much at stake, how do medical affairs teams in the pharmaceutical industry ensure they are working above board? By performing thorough debarment checks.

The importance of debarment checks

A debarment check ensures that you have not hired debarred individuals or contracted with debarred entities at any point in the process of bringing a drug to market. When applying to the FDA for approval of a drug, medical affairs professionals at pharma and biotech companies are required to certify that they have not and will not engage in such a hire.

Regular debarment checks are necessary to avoid regulatory penalties, not to mention the bad press or approval delays that could also result for your business if you fail to catch a debarment issue.

When it comes to publication management, the debarment check protects your company against liabilities financial, reputational, and even social. Thorough and regular checks help medical affairs professionals avoid costly fines, protect against damage to company credibility, and prevent go-to-market delays. They also protect consumers and help to maintain the integrity of the FDA as it works to protect consumers as well. When debarment checks work as advertised, it benefits everybody.

Ensuring ongoing compliance with the FDA debarment list

Of course, with the FDA debarment list being continuously updated, ensuring compliance requires ongoing debarment checks. This does not mean that the process has to remain laborious, or turn into a cost that you “just have to eat.”

This is where automation comes in. With the power of low-code automation, medical affairs professionals can build a solution designed with their complex SOPs and compliance requirements in mind — all without having to spend an unreasonable amount of time and money on manual or outsourced debarment checks. 

Automated debarment checks in publication management

The benefits of automation in the publication management process, including debarment checks, are numerous.

First, consider the sheer number of administrative tasks that medical affairs teams need to complete to support the development and approval of a new drug, in compliance with regulations both domestic and international. 

Extending to debarment checks and beyond, smart automations that fit to your existing processes and workflows are sure to introduce new efficiencies that save time and money, resulting in better margins on R&D as well as greater speed-to-market.

PubPro by BP Logix was created with these specific goals in mind. With PubPro, medical affairs directors and managers can:

• Manage publication process timelines, including via metrical data for identifying efficiencies and bottlenecks
• Intelligently route and approve tasks
• Collaborate across document authoring, to conduct quality checks and manage feedback
• Customize reviewer assignments
• Resolve high-stakes compliance gaps, including debarment checks and training verifications
• And more!

This robust automation system produces many efficiencies, including ensuring compliance more quickly, so that you and your team can focus less on administrative work and more on the remainder of the publication management process. PubPro can conduct automated debarment checks for not only the FDA database, but also the OIG (Office of Inspector General) and SAM (System for Awards Management) databases.

Improve compliance and speed up your publication process with PubPro.

Contact us today to learn more about our solution built for medical affairs teams.

Heavily regulated industries inherently have a lot of rules. The biotech and pharmaceutical industries are no exception. Adhering to complex regulations requires significant amounts of administrative work to ensure that the proper directives are being followed. Extensive regulations also present significant risks of hefty fines for noncompliance. Failed clinical trials also present a significant risk to pharmaceutical companies and can cost billions a year. 

Getting a new drug to market involves an infinite number of variables, many of which influence who needs to sign off on content development and research projects. This leads to a very complex process that, if done manually, can be very inefficient.

While eliminating steps in the approval process can lead to losses, waiting for approvals that delay a new product’s launch can be equally costly. Streamlining the approval process improves time to market while reducing risks. An effective business process automation strategy is key to a much more efficient approach.  

Research concept approval

The process of getting a clinical trial approved and budgeted often requires the collection and organization of significant amounts of data. Researchers must submit information on the type of study, the objective of the study, the subject of the study, and use case descriptions. This data needs to be accurately and completely documented for researchers to have any chance of obtaining the resources to move forward. Automating this process with digital forms that enforce requirements can ensure all the necessary application data is present, mitigating the risk of delays or bad clinical studies moving forward. 

Once the data is collected, the proposal needs to be vetted and approved. Who needs to approve the project and in what order is often driven by several variables. Whether a project is studying a molecule or a device may dictate whether legal, medical, or regulatory experts need to approve it. Significant efficiencies can be realized by incorporating these rules into an automation system that defines the approval path.

Pharma Content Approval Processes

Once research is completed or drugs are ready for the market, the process of disseminating information and data on these advancements requires significant scrutiny. 

Scientific Publication Review

Once new findings from research studies are ready for publication, an extensive review process is initiated. Reviewers may include third-party experts and professionals with diverse backgrounds. The appropriate protocol depends on the type of product being studied, the country or region the data is being published, or the type of data being presented. For example, some products may require review by a minimum number of statisticians or lawyers. Finding the right resources and routing the document efficiently to each expert for their review is a complex process that can easily be held up or delayed. Automating the routing process based on these variables can eliminate the manual process of designing workflows for each individual project. 

Marketing Content Review

Publishing marketing content also requires multiple levels of approval before it can be made available to the general public. But, marketing content comes with an additional level of complexity and risk. 

Marketing content can be delivered through a variety of channels and in different forms, leading to a much more complex approval process. Video is created for TV or the internet, web copy and brochures also need to be created to publicize the benefits of a new drug or device. Content can also be developed for different markets that speak different languages. All this content is required to go through a specific approval process and each of these variables dictates the appropriate path. 

Managing the approval process through multiple levels including legal, medical, marketing, and patent review slows the process of getting products to market. But, it is vital marketers get this approval process right. Ineffective management of the process can lead to misleading messaging reaching the public resulting in significant penalties. For example, publishing content that overemphasizes the benefits of a new product that is not balanced with acknowledgments of side effects and risk factors can result in hefty fines. In 2012 GlaxoSmithKline was fined $3 billion and Abbott paid $1.6 billion for miscommunicating information in direct to consumer advertising

Automation

Automating the approval process provides many benefits. Rules and variables can be used to automatically route content to the appropriate reviewer. By digitizing and automating the process, sophisticated systems can not only ensure content is signed off on by the appropriate authorities but can also calculate the most efficient route to final approval. For even greater efficiency, leading platforms can also create parallel paths so reviews can happen simultaneously on a single document. 

Time to market is a competitive differentiator in the pharma space but shortcuts can be costly. A solid automation strategy can streamline the approval process, reducing risk and increasing competitiveness.