Featured Articles

1. Real-World Evidence Revisited 4/6/2026

   Explore how the latest regulatory updates transform real-world data into a credible evidentiary pathway. Learn the new standards for data reliability and hybrid study design.

2. General Wellness Isn't A Vibe Anymore: What The 2026 FDA Update Means 4/6/2026

   The FDA’s 2026 guidance has put an end to "wellness by disclaimer." Learn how new standards for wearables and apps impact study design, participant safety, and the evolving ethical role of the IRB.

3. Clinical Decision Support Software: Clear Expectations For Research Oversight 4/6/2026

   The FDA’s 2026 CDS guidance signals a shift to settled policy. IRBs must now demand greater transparency regarding automation bias and clinician independence to accurately assess study risk.

4. The FDA's Final BIMO "Processes And Practices" Guidance 4/6/2026

   Gain a clear roadmap for investigators, sponsors, and IRBs. This shift toward transparency replaces regulatory guesswork with predictable standards for every partner in the research ecosystem.

5. What Does The FDA's 2025 Safety Reporting Guidance Mean For You? 4/6/2026

   New FDA guidance aligns IND safety reports with unanticipated problems, shifting the focus from administrative definitions to proactive participant protection and trial integrity.

6. Clinical Research Update: The New FDA Form 1572 is Available 3/5/2026

   Stay current with the latest FDA investigator filing updates. Learn when to transition to the new version and how to maintain compliance without unnecessary administrative re-work.

7. FDA Updates Guidance For Written IRB Policies 3/5/2026

   Explore how updated FDA and HHS guidance harmonizes regulations, streamlines IRB operations, and strengthens oversight for complex clinical trials.