ACT Brief: eSource Standardization Advances, Digital Protocols Gain Momentum, and Rare Disease Trial Risks Intensify

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

• In Part 2 of a recent video interview, Jonathan Andrus, co-CEO of CRIO, said eClinical platforms are evolving toward protocol-driven eSource tools that standardize data collection at the site level. By translating study protocols into structured templates with built-in validation and edit checks, sponsors can improve data quality at the point of care while still allowing flexibility for site-specific workflows.
• In a new contributed article from IQVIA, insights from the 2026 SCOPE conference highlight a broader shift from document-based processes to connected, data-centric ecosystems. Advances such as digital protocols, interoperable data standards, and cross-sponsor data sharing are enabling more efficient study start-up, improved site selection, and more reliable patient experience data across the trial lifecycle.
• Roche has discontinued its Phase II SHIELD DMD study evaluating satralizumab, underscoring increasing execution risk in rare disease trials. Despite no new safety or efficacy concerns, limited recruitment and challenges generating regulatory-grade data led to the decision, highlighting how operational feasibility and evidentiary expectations are becoming key determinants of trial viability.

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