Featured Editorial

1. 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.

2. 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.

3. 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.

4. 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.

5. 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.

6. 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.

7. RFK Jr. Wants Every American Wearing A Wearable. How Can Pharma Build A Business Around It? 9/16/2025

   The timing is now for pharma to be all-in on using wearables as their new business strategy, says Digital Medicine Society (DiMe) Director of Partnerships Smit Patel, PharmD.

8. Developing A Risk-Based Model For Computer System Validation 9/11/2025

   Consultant Richie Siconolfi explores risk factors that can be used to develop a risk-based approach to computer system validation.

9. The Dream Is EHR-To-EDC — eSource Is The Wake-Up Call 9/11/2025

   EHR-to-EDC integration promises efficiency but struggles with interoperability, compliance, and site adoption. eSource emerges as the real bridge, with case studies like MSK proving it can cut setup times, boost accuracy, and lighten site workload.

10. 3 FDA Guidance Documents That Shaped Today's Computer System Validation 9/10/2025

    Consultant Richie Siconolfi outlines three FDA guidance documents for evaluating and mitigating risks in validating computerized systems.