ICH E6(R3): Transforming the Future of Clinical Trials with Enhanced Efficiency, Safety, and Innovation—A Commentary

Clinical Researcher

The International Council for Harmonization E6(R3) Good Clinical Practice guideline was recently updated to enhance patient safety, optimize clinical trial efficiency, and improve data integrity within clinical research. The authors of this commentary believe these modifications will have a positive impact on how clinical trials are conducted by increasing participant involvement, while maintaining data integrity and compliance.

Driving Clinical Data Transformation Through Strategic Sponsor and CRO Collaboration

Clinical Researcher

For sponsors and contract research organizations (CROs), trial complexity is increasing due to novel protocol requirements and greater demands on data volume and variety, among other factors. Meanwhile, the research and development product pipeline doubled from 2013 to 2023. Sponsors are increasingly leaning on CRO expertise for newer therapeutic areas, technology infrastructure, evolving regulatory expertise, change management, and more.
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Bridging Sponsors and Sites: The Changing Role of the CRA

Blog

With a focus on prioritizing patient and investigator needs, the traditional sponsor-contract research organization relationship is evolving to include sites as part of the partnership matrix. This, combined with the increasing adoption of Functional Service Provider delivery models, has made determining the right balance of control and accountability for each party a critical factor in successful outsourcing partnerships.  

HHS Budget Cuts Threaten the Future of Clinical Trial Innovation

Blog

As Chief Clinical Trial Officer at Florence Healthcare, Catherine Gregor has the privilege of collaborating with research sites, sponsors, and CROs on the frontlines of clinical trial operations. Every day, she witnesses the dedication and innovation required to bring new treatments to patients swiftly and safely. However, the recent announcement of significant workforce reductions at the U.S. Department of Health and Human Services (HHS) poses a substantial threat to this progress.