FDA Accelerated Approval Guidance: How Automation Ensures Compliance
The FDA’s Accelerated Approval Program was created to fast-track life-saving drugs for serious diseases, allowing life science companies to bring new ...
Webinar Recap: Streamlining Medical Affairs Operations with Technology
In recent years, medical affairs has evolved from a regulatory requirement to a service organization, providing services across functions in ...
Automating Publication Management for Medical Device Companies
The medical device industry is facing mounting pressure to adopt more rigorous publication management practices as regulatory requirements evolve. ...
Navigating Uncontrollable Challenges in Medical Affairs
In the life sciences industry, even the best-laid plans can be derailed by circumstances beyond a company’s control.
Boost Clinical Trial Safety With Automated Adverse Event Handling
During clinical drug trials, ensuring patient safety and maintaining regulatory compliance is of paramount importance.
Medical Affairs Software: Stuck Between Complexity and Chaos
As the life sciences industry evolves, medical affairs teams are left wondering why software solutions haven't kept pace with their needs. Despite ...
Practical Applications of AI/ML in Medical Affairs
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 ...
Process Automation: The Meaning of Complexity
Business processes are the lifeblood that keeps organizations thriving. Yet, not all processes are created equal. Some are straightforward and ...
How Manual Tools Fall Short for Regulatory Affairs Processes
Efficient processes are critical for regulatory affairs teams aiming to bring new drugs to market. However, many organizations still depend on ...
