Process Debt in IIS Approvals: Why Medical Affairs Needs Control
Medical Affairs just revised your IIS review protocols. Perhaps oncology studies now need a different review structure. Maybe compliance thresholds ...
Plain Language Summaries: How AI Helps Medical Affairs Scale
Learn how Medical Affairs teams using governed AI tools are able to meet increasing plain language summary (PLS) expectations without scaling budgets.
Shadow AI in Life Sciences: The Compliance Gap Nobody Talks About
Why ungoverned AI tools are filling the gaps your workflow platform left behind.
How to Close Pharma's Collaboration Gap
Why Medical Affairs, Clinical, Regulatory, and Commercial still can't align and what infrastructure actually solves it.
IIS Concept Review Process: Email Isn't Infrastructure
When was the last time you searched through email threads to find an IIS approval status? If you're like most Medical Affairs professionals, it was ...
Rapid Regulatory Shifts: How Medical Affairs Can Keep Up
Medical Affairs teams used to have weeks or months to respond to regulatory changes. Now they often only have days (or sometimes just hours).
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. ...
