Newsletter | November 20, 2025

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

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FEATURED EDITORIAL

How The FDA, MHRA, And 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.

INDUSTRY INSIGHTS

The Strategic Advantage Of eCOA And IRT

The future lies in unified, interoperable eCOA–IRT solutions that streamline operations, improve data integrity, and enhance patient and site experience.

Why Use Scorecards To Make Vendor Selection Decisions

Scorecards enable structured, unbiased vendor selection by transforming complex clinical trial decisions into transparent, data-driven evaluations — ensuring operational excellence and regulatory compliance.

Responsible Use Of AI In Healthcare: Work In Progress

Delve into the transformative role and potential benefits of artificial intelligence (AI) in healthcare and learn why it's crucial to carefully consider and plan for the responsible use of AI.

Investigator Databank And DQS: Welcoming New Consortium Members

Join the Data Query System consortium to access a comprehensive, collaborative platform that enhances clinical trial feasibility, site selection, and investigator engagement.

Accelerating Data Cleaning

AI-enabled clinical trial technology enables faster processing of large data volumes, thereby enhancing workflows, easing the burden on busy trial teams, and protecting patients.

The EMR Interoperability Dream vs. Clinical Research Reality

Seamless Electronic Medical Record access promises accelerated trials and regulatory-grade evidence, but incomplete, unstructured data requires hybrid strategies to bridge gaps.

Mitigating Risk And Complexity In Cell & Gene Therapy Trials With IRT

CGT pioneers require supply chain partnerships that mitigate trial risk and complexity. Explore how to optimize pre-trial and pre-screening activities and reduce trial cost and risk with an IRT solution.

SOLUTIONS

A New Digital Health Solution For Long-Term Cough Monitoring

Real-World Data And Real-World Evidence

Streamlining eCOA For Modern Clinical Trials

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