Best of September 2025: Top 5 Insights In Clinical Trial Technology

#1 - 3 FDA Guidance Documents That Shaped Today's Computer System Validation

There are three FDA guidance documents that allow the regulated industry to take risks in validating computerized systems.Understanding the history of such guidance can help industry contextualize today’s approach to computer system validation (CSV).

#2 - A Guide To Electronic Data Capture (EDC)

EDC systems are designed to support a wide range of clinical research while ensuring compliance with global regulatory standards, revolutionizing data management in clinical trials.

#3 - How To Pick The Perfect ePRO/eCOA For Your Trial (And Everyone In It)

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? Here’s a practical, field-tested framework for getting that decision right.

#4 - Driving Site Activation: How Sponsors Can Enable Research-Naïve Clinical Trial Sites

Clinical trial capacity in the U.S. is heavily concentrated, and technology is playing a critical role in enabling a shift to expanding site networks and alleviating the burden on sites and patients.

#5 - The Dream Is EHR-To-EDC — eSource Is The Wake-Up Call

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.