Newsletter | November 26, 2025

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

SPONSOR

Clinical trials drive medical progress, and SCOPE brings the community together to advance them. Returning February 2–5, 2026, in Orlando, SCOPE builds on 2025’s record 4,500+ attendees, 630 speakers, and 300 exhibitors. The 2026 program features 30 tracks, new additions in Market Access, Safety, and Therapeutic Areas, major awards, and expanded coverage of AI, patient-centric design, site engagement, and trial operations. SCOPE unites global leaders shaping the future of clinical research. www.SCOPEsummit.com

TRIAL MANAGEMENT

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.

Accelerate Drug Development With Master Protocols

Through careful planning, aligned incentives, and an open, adaptive mindset, master protocols become powerful engines for accelerating therapies to market—particularly in high-need therapeutic areas.

Ensuring The Efficacy Of Probiotic Products

Without proper handling and packaging, the efficacy of probiotics can be compromised at any point in the packaging, storage, and transportation process, impacting shelf life and effectiveness.

Intelligent Trials AI Guide

Clinical trials face rising complexity, recruitment challenges, and high dropout rates. Standardized data and predictive modeling can improve decision-making, site selection, and operational efficiency.

Central IRB Services

Get fast, reliable IRB review for multisite studies backed by expert oversight and responsive support with streamlined submissions, frequent meetings, and dedicated client managers.

Shorten Start-Up Times For Your Clinical Research

SuiteSuccess allows CROs to unify applications to improve visibility and oversight in one software platform. Automate inefficient manual processes and deliver more quickly and more profitably.

SPONSOR

Spotlight the Best in CRO Partnerships—Share Your Voice!

Help shape the future of CRO excellence! Take part in the 2025 CRO Leadership Awards Survey, conducted by Tufts CSDD and Clinical Leader. Your confidential feedback will determine the top CROs in project management, services, culture, and more. Winners will be celebrated through Clinical Leader events—don’t miss your chance to spotlight outstanding collaboration in our industry!

DECENTRALIZED TRIALS

Bridging Community And Central Hospitals With Japan's DCT Model

Regulatory support and improved DCT infrastructure, as well as a uniquely Japanese approach to site relationships, are advancing the DCT landscape in Japan.

Leveraging AI In HEOR: Innovation In Evidence And Outcomes

Stay at the forefront of digital innovation in healthcare and understand how artificial intelligence is revolutionizing Health Economics and Outcomes Research (HEOR).

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