Newsletter | December 12, 2025

12.12.25 -- FDA Vs. MHRA Vs. EMA: Differences In Externally Controlled Trials

TRIAL MONITORING

Mastering The Monitoring Visit: Key Tips For Site Success

The ACRP Atlanta Chapter recently hosted a Lunch-n-Learn session on “Mastering the Monitoring Visit: Key Tips for Site Success.” The conversation highlighted the shared goal of CRAs and CRCs: ensuring compliance, protecting data integrity, and making monitoring visits a collaborative — not adversarial — experience.

Fixing The Monitoring Model: Flexible Resources For Trial Success

Discover how flexible, site-focused monitoring strategies are transforming clinical trials by improving communication, enhancing compliance, and resolving challenges before they impact study success.

Monitoring Application: A Flexible Technical Solution

This dynamic, system-agnostic approach to modernizing clinical trial monitoring supports targeted oversight, as well as sampling at the subject, visit, and form levels.

CLINICAL DATA MANAGEMENT & ANALYTICS

FDA Vs. MHRA Vs. EMA: Differences In 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.

A New Take On The Evolving Role Of AI In Clinical Trials

Artificial intelligence is shifting from promise to practice in biopharma. Zhong Lu, director of data science and AI at Novartis, outlines how AI is evolving the clinical trials process end-to-end.

How AI-Enhanced CAPA Systems Actually Work

Learn how AI can accelerate root cause analysis, predict quality risks, and streamline CAPA without compromising compliance or overwhelming your team with practical strategies.

Unlock Efficiency And Compliance With Data Modernization Solutions

For life sciences leaders and professionals, this piece offers a practical framework to turn data management into a driver of efficiency, compliance, and innovation.

Clinical Analytics Use Cases For AI

Automating FDA data validation rules and analyzing audit trail data can significantly reduce fraud and predict areas of concern. Discover how these advancements can transform your clinical trials.

Future Of AI Analytics In Chronic Pain And Neurological Research

This presentation explores how digital health tools and AI diagnostics are transforming clinical research, driving accurate evaluations and faster therapy development for chronic pain and neurological disorders.

Why SSO Integrations Matter For Sites And Sponsors

Multiple logins slow down site staff. Seamless SSO integrations reduce friction, eliminate extra steps, and help coordinators stay focused on trial execution — not portal management.

Drug Development Strategy And Analytics

Read how IQVIA Biotech can help develop a strategy that will effectively translate into trial execution and avoid costly amendments down the road.

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  • Clinical Sites | Patient Centricity | Patient Recruitment (Monday)
  • Clinical Trial Technology (Tuesday)
  • Decentralized Trials | Trial Management (Wednesday)
  • Outsourcing Models | Regulatory & Compliance (Thursday)
  • Clinical Data Management & Analytics | Trial Monitoring (Friday)

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