Newsletter | March 6, 2025

03.06.25 -- FDA Issues Draft Guidance On The Use Of AI

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What’s the real impact of the "one-and-done PI" in clinical trials? Some say it’s a major issue, while others question if it’s a concern at all. Clinical Leader Live’s expert panel—backed by research—dives into the data, debate, and potential solutions. Join this free digital event!

REGULATORY & COMPLIANCE

FDA Issues Draft Guidance On The Use Of AI To Support Regulatory Decision-Making For Drug And Biological Products

The U.S. FDA issued a draft guidance, Considerations for the Use of Artificial Intelligence to Support Regulatory Decision-Making for Drug and Biological Products, on January 6, 2025. The public comment period ends April 7.

Understanding The FDA's Push For Representation In Clinical Trials

Take action to improve diversity in clinical trials by addressing underrepresentation and ensuring equitable access to medical interventions, as emphasized by the FDA’s new 2025 guidance.

Ensure Seamless Clinical Trial Transition Across Global Markets

If you want to increase speed and reduce costs while still procuring high-quality data for your clinical trial, consider the impact of launching an early-phase clinical trial in Australia.

GxP Quality Assessment And Remediation

Ensure regulatory compliance and foster continuous improvement through the use of comprehensive GxP quality assessment and remediation services.

End-To-End Safety Solutions Designed For Success

As one of the world’s largest and most experienced safety and PV organizations, unearth how this provider is bringing extensive expertise and regulatory intelligence to every industry engagement.

OUTSOURCING MODELS

CRO Summit Chair Muses On The Future

Clinical Outsourcing Group CRO Summit Chair and seasoned biopharma CxO Jasmina Jankicevic shares her insights on the evolving landscape of CROs. 

Key Strategies For Clinical Development in Rare Cancers

Successful execution of rare cancer clinical trials requires strategic patient recruitment, innovative trial design, and specialized expertise from Oncology CROs.

Accelerating Biologics Through Development Milestones

Whether you're aiming to run a pivotal trial or multiple studies, discover how Veristat's full-service support can drive your biologic therapies from inception to market success.

Bioanalysis Solutions

Learn how a bioanalytical testing partner with comprehensive solutions and unwavering commitment to quality can help you bring safe and effective drugs to market with confidence.

Isotope Labelling

Whether you need isotopically labeled (14C/SIL) compounds for nonclinical or clinical metabolism studies and the quantification of materials in biological matrices, our expertise provides the necessary labeled materials tailored to support your studies.

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