ACT Brief: Real-Time Trial Infrastructure Gaps, Built-In Data Security, and AI-Enabled CDMO Value

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

• A new FAQ on ACT examined the FDA's real-time clinical trial proof-of-concept studies with AstraZeneca and Amgen, finding most sponsors lack unified infrastructure and quality-by-design practices needed for continuous oversight. Protocol digitization, enterprise-level RBQM beyond study-by-study siloes, and transparent AI governance are critical investments for meeting emerging regulatory expectations for near real-time safety and endpoint visibility.
• In a new contributed article, Emma McDonald from SAS argued that clinical data security must be built into system architecture from the foundation rather than layered on afterward, reducing regulatory risk while improving team confidence and accelerating research. Well-designed cloud-native environments can often support stronger security postures than on-premise setups, and when security is designed in, it becomes an enabler rather than a constraint on research velocity.
• At BIO 2026, Anil Kane, global head of technical and scientific affairs at Thermo Fisher Scientific, discussed how AI is reshaping CDMO value creation across preclinical, clinical, quality, and supply chain operations. Biotechs should prioritize regulatory experience, quality track record, and scientific depth across modalities when selecting a CDMO partner capable of carrying programs through full development and commercialization.

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