Newsletter | December 2, 2025

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

Clinical Tech Leader

TOP 5 INSIGHTS IN CLINICAL TRIAL TECHNOLOGY
NOVEMBER EDITION

#1 - How The FDA, MHRA, & EMA Differ On Externally Controlled Trials

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.

#2 - Following Up: Your Top Questions From Our EHR-To-EDC Integration Webinar Answered

This follow-up article distills the top unanswered questions from CRIO’s EHR-to-EDC integration webinar, offering clear guidance on implementation, data quality, compliance, and future-ready site technology. Learn how these models can reduce site burden and transform clinical data workflows.

#3 - Penetration Testing In Healthcare: Common Vulnerabilities And Programs To Address Them

Penetration testing is becoming essential for healthcare organizations as recurring vulnerabilities continue to expose patient data and regulatory risk. Read this article to learn the most common pitfalls and how to build an effective, compliant penetration testing program that actually strengthens security.

#4 - Reframing Vendor Selection: Beyond Price And Past Relationships

This article explains why RFPs should be strategic communication tools—not just budget exercises—and how structured, transparent processes lead to better vendor selection and trial outcomes. Discover how Clin.AI helps sponsors build stronger RFPs, compare bids intelligently, and choose partners who can truly deliver.

#5 - How The TMF Demonstrates Patient Safety And Rights In DCTs

Donatella Ballerini argues that in decentralized clinical trials, the TMF is no longer just a compliance archive but a powerful record of how patient safety, rights, and trust are protected throughout the study. See how the TMF can evolve into a true patient-centric safeguard in modern DCTs.