Featured Editorial

1. 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.

2. 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.

3. 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.

4. 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.

5. 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.

6. How To Pick The Perfect ePRO/eCOA For Your Trial (And Everyone In It) 9/8/2025

   Choosing the right ePRO/eCOA platform isn’t about comparing feature lists. It’s about asking: Will this work for patients, for sites, and for the trial as a whole?

7. How AI Can Accelerate Clinical Trials' Probabilities Of Technical And Regulatory Success (PTRS) 8/21/2025

   AI expert Kelly H. Zou, Ph.D., explores how the technology can drive R&D successes, including clinical trials.

8. Ask An Expert Before Shredding Your Mobile Device CAPEX 8/14/2025

   Tasked with buying your company's mobile devices and not sure where to start? Discover the questions you should ask and the information you need to know before consulting an expert.

9. Synthetic Control Arms: When Data Stands In For Patients 8/14/2025

   Synthetic control arms replace traditional control groups with carefully matched historical or real-world data, offering an option for rare diseases, ethical constraints, or when high-quality datasets exist. They can speed access to treatments, but success depends on rigorous data matching, upfront planning, and early regulatory engagement.

10. FDA's Elsa May Prompt Pharma To Rethink Regulatory Filings 8/13/2025

    AI expert Pradeepta Mishra of Beghou Consulting explains why pharmaceutical companies need to quickly evolve their regulatory strategies, authoring procedures, and governance frameworks in light of the FDA's new Elsa generative AI pilot.