News|Podcasts|February 26, 2026

ACT Brief: Data Fragmentation Risks Rise, Outsourcing Models Evolve, and FDA Pathways Face Pressure

In today’s ACT Brief, we examine how fragmented data collection continues to challenge trial quality, how hybrid outsourcing and AI are reshaping execution strategies, and why calls are growing for a risk-based FDA pathway for early-stage studies.

This is the Applied Clinical Trials Brief—your fast track to the latest insights shaping clinical operations and drug development.

In Part 3 of a recent video interview, Jonathan Andrus, co-CEO of CRIO, said fragmented data collection across sites remains a major operational risk in 2026. Variability in how sites capture and manage data continues to create downstream challenges for quality and reconciliation, while purpose-built eSource systems offer a path to reduce discrepancies and enable earlier issue detection at the point of capture.
In a new FAQ article on ACT, evolving outsourcing strategies reflect growing demand for flexibility as trial complexity increases. Hybrid models that blend full-service and functional approaches are gaining traction, alongside AI-enabled workflows that support more adaptive resourcing and closer collaboration between sponsors and CRO partners.
A recent analysis in Pharmaceutical Executive argues that US regulatory inefficiencies are pushing early-stage trials overseas despite existing authority within the FDA to address the issue. The piece calls for a risk-based pathway for low-risk studies using enforcement discretion, which could accelerate trial starts while allowing the agency to better focus resources on higher-risk oversight.

That’s all for today’s ACT Brief. Join us tomorrow for more updates shaping clinical operations and drug development. Thanks for listening.

Stay current in clinical research with Applied Clinical Trials, providing expert insights, regulatory updates, and practical strategies for successful clinical trial design and execution.

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