Featured Editorial

1. How AI Is Rewriting The Future Of TMF And Clinical Quality 10/29/2025

   Discover how AI is transforming the TMF from a reactive repository into a proactive, intelligent co-pilot for clinical trials.

2. Penetration Testing In Healthcare: Common Vulnerabilities And Programs To Address Them 10/28/2025

   Explore some of the common pitfalls witnessed in healthcare environments, as well as guidance for implementing a penetration testing program. 

3. Penetration Testing In Healthcare: HIPAA And GDPR Requirements 10/27/2025

   Learn about penetration testing requirements in the healthcare environment, including clinical research, according to HIPAA and GDPR. 

4. How The FDA, MHRA, & EMA Differ On Externally Controlled Trials 10/23/2025

   As the FDA, MHRA, and EMA release draft frameworks on externally controlled trials, sponsors face differing expectations. The U.K. leans pragmatic, the U.S. remains cautious, and Europe’s guidance is still evolving — leaving global trial planners to navigate regulatory gray zones.

5. What Sites Wish Tech Vendors (And Sponsors) Heard At SCDM But Probably Didn't 10/8/2025

   During a Society for Clinical Data Management (SCDM) panel discussion, three site-side representatives discussed the challenges clinical research coordinators have executing their clinical duties amid increasingly complex data entry demands.

6. SCDM 2025: Practical Advice From Global Regulators — Including The FDA 10/6/2025

   Discover what regulators from around the world, including the FDA, think should be top of mind for clinical data managers.

7. RWE Is Growing Up, And Here's Why That Matters 9/29/2025

   Real-world evidence is shifting from the margins to the mainstream of drug development, but data quality, trust, and regulatory clarity remain hurdles. ISPOR is helping set the standards to guide its future.

8. Powering Standards With Code: The Role Of Open Source In CDISC 360i 9/26/2025

   Discover how to implement CDISC standards in automated research data pipelines that are fast, scalable, and reliable.

9. Combining RWD And Machine Learning To Determine Meaningful Patient Populations 9/22/2025

   Combining RWD with advanced ML models offers a powerful and transformative solution to optimize patient recruitment.

10. RWD Helps Abbvie Bridge Oncology Trial Data Gaps 9/18/2025

    AbbVie Vice President of Global and U.S. Medical Affairs Oncology Svetlana Kobina, MD, Ph.D., discusses how integrating real-world data (RWD) with RCTs can fill critical data gaps.