ACT Brief: Neutral Tech Adoption at Sites, Scaling Unstructured Data for eSource, and Novo Nordisk’s CagriSema NDA

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

• In part two of a video interview series, Kevin Williams of Ledger Run discusses how sponsors are evaluating new engagement systems amid concerns from site staff that trials are becoming harder to manage. Williams explains that not all new technologies are designed to immediately reduce site burden, and in some cases the initial goal is to ensure new systems do not add operational complexity at the site level. He notes that sponsors and CROs are increasingly applying a phased “crawl, walk, run” approach to technology adoption, prioritizing site neutrality before pursuing longer-term efficiency gains.
• New research on eSource adoption finds that while EHR-to-EDC workflows are expanding, scaling their impact will depend on incorporating unstructured clinical data such as notes, reports, and imaging. The study reports that more than 80% of healthcare data remains unstructured, limiting the reach of current eSource implementations, particularly in oncology and rare disease trials. Researchers highlight the role of AI and natural language processing in structuring these data, while emphasizing the need for shared validation frameworks, interoperability standards, and collaborative models among hospitals, sponsors, and technology providers.
• Novo Nordisk has announced the submission of a New Drug Application to the FDA for CagriSema. The NDA is based on results from the Phase III Redefine clinical program evaluating CagriSema for long-term weight management in adults with obesity or overweight with weight-related comorbidities. If approved, CagriSema would become the first injectable combination therapy pairing a GLP-1 receptor agonist with an amylin analogue, with FDA review expected in 2026.

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