ePRO/eCOA Featured Articles

1. FDA's Draft Guidance On Bayesian Methods: Strategic Implications For Small Biotechs 3/4/2026

   The FDA draft guidance on Bayesian methodology represents a major validation of statistical innovation in clinical development. Jessica Cordes summarizes the latest from the FDA and offers advice for small biotechs.

2. How Regulatory Convergence Is Rewriting Clinical Data Management 2/22/2026

   Regulatory shifts toward structured, digital clinical trial protocols are reducing manual interpretation, enabling risk-based oversight, and supporting more efficient, transparent, end-to-end trial execution.

3. Sponsor-Provided Source Templates: Your Questions Answered 2/6/2026

   See how centralized eSource improves trial operations through faster startup, better data quality, and real‑time protocol guidance. An expert Q&A offers practical tips for sponsors, sites, and CROs.

4. 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.

5. Following Up: Your Top Questions From Our EHR-To-EDC Integration Webinar Answered 10/23/2025

   We’ve compiled this follow-up with detailed answers to remaining questions, organized by theme to help you explore topics and advance the conversation on seamless EHR-to-EDC integration.

6. 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.

7. Driving The Next Wave Of Innovation In Clinical Data Management 10/2/2025

   To better accommodate growing clinical data volume and decentralized trials, many organizations are activating AI-enabled trial tools to enhance workflows and ensure real time data review.

8. 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.

9. Paving The Way For Sites To Use Their Own Tech 7/17/2025

   The DTRA has released a detailed playbook to help clinical research sites use their own validated technology in sponsor-led trials. The "Bring Your Own Technology" (BYOT) model aims to reduce tech overload at sites, improve efficiency, and preserve regulatory compliance — starting with eConsent as its first use case.

10. Feasibility/Site Selection Process Ripe For Improvement 4/1/2025

    One key to a more effective feasibility process is more transparent communications and collaboration between sponsors, CROs, and sites. Sponsors must provide clear information to each site to enable a more accurate recruitment assessment, and sites must properly digest the information to give an accurate projection. But how?