ACT Brief: eSource Moves Toward AI-Enabled Validation, Outsourcing Models Shift Toward Flexibility, and Robust Trial Design Becomes Mission Critical

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

• A new ACT FAQ outlines how EHR-to-EDC integrations are reducing manual transcription and improving data accuracy, while artificial intelligence is increasingly used to support quality checks and monitoring under human oversight. However, long-term scalability will depend on validation frameworks, regulatory alignment, and collaboration across sponsors, sites, and vendors to ensure AI-enabled workflows can be trusted and adopted at scale.
• A new ACT contributor article highlights growing adoption of the functional-service provider model, which allows sponsors to retain strategic oversight while leveraging CRO expertise to improve efficiency and resource allocation. Success depends on treating CROs as strategic partners, with strong communication and shared planning helping organizations transition without disrupting study timelines or quality standards.
• Finally, a new industry perspective emphasizes how adaptive trial designs and simulation-based planning allow sponsors to build flexibility into protocols and respond to real-world variability. By anticipating uncertainty early and adjusting designs as data emerges, sponsors can protect statistical integrity and improve the likelihood of achieving primary endpoints when outcomes matter most.

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