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FDA Crackdown on Trial Design: What July’s CRLs to Replimune and Capricor Mean for Sponsors

July 25th 2025

Complete Response Letters recently issued by the FDA signal heightened scrutiny of trial design and reinforce the agency’s shifting regulatory expectations for sponsors and CROs.

 Empowering the Workforce of the Future: The Trends and Training That Will Drive the Future of Drug Development
Empowering the Workforce of the Future: The Trends and Training That Will Drive the Future of Drug Development

July 15th 2025

Obsolete Trial Marketing Guidelines and Missing Processes Hurt Patient Enrollment
Obsolete Trial Marketing Guidelines and Missing Processes Hurt Patient Enrollment

July 8th 2025

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Rewiring Clinical Research: AI-Augmented Data, Processes, and People

June 26th 2025

Clinical Trials as a Competitive Edge: Strategic Considerations
Clinical Trials as a Competitive Edge: Strategic Considerations

June 16th 2025

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