News|Podcasts|June 30, 2026

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

In today's ACT Brief, we examine what the FDA's real-time oversight initiative demands of sponsors, why clinical data security must be designed in rather than layered on, and how AI is reshaping CDMO workflows and asset 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.

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

Related to this article

September 21st, 2026

ACT Brief: Patient-Site Trust and AI Role, Platform Approach to Scale, Gene Therapy for Pediatric Disease

In today's ACT Brief, we examine what patient-site relationships need most at DPHARM, how platform-based AI scales across workflows, and FDA's approval of a gene therapy for a rare childhood syndrome.

September 18th, 2026

ACT Brief: Patient Voice as Methodology, AI System Bottlenecks, Regulatory Convergence on Patient Input

In today's ACT Brief, we examine what genuine patient voice requires beyond buzzwords, why AI's next bottleneck is system integration not models, and how regulators across three jurisdictions are formalizing patient input requirements.

September 17th, 2026

ACT Brief: Expedited IND Pilot Launch, Operating Model Importance, and Readiness Prediction

In today's ACT Brief, we examine FDA's expedited pathway for first-in-human trials, why operating model design matters more than sourcing strategy, and how early readiness signals predict trial risk.

September 16th, 2026

The Human Side of Clinical Trials: How Measuring Readiness at Training Predicts Trial Risk Before It Shows Up in the Data

This episode of The Human Side of Clinical Trials, hosted by Brian S. McGowan, PhD, FACEHP, chief learning officer and co-founder of ArcheMedX, Inc., and Kelly Ritch, chief operating officer of ArcheMedX, Inc., explores why training completion metrics like attendance and quiz scores fail to capture true study readiness, and how measuring both competence and confidence can reveal trial risks before enrollment even begins.

September 16th, 2026

ACT Brief: Epilepsy Trial Feasibility and Family Realities, CRO Partnerships and Strategic Value, and Cortisol and GLP-1 Response

In today's ACT Brief, we examine what families with rare epilepsy teach about trial feasibility, how preclinical CRO partnerships are evolving beyond transactional services, and why cortisol dysregulation limits GLP-1 effectiveness in diabetes.

September 15th, 2026

ACT Brief: Endpoint Selection and Patient Engagement, Execution Infrastructure Before AI, and Real-World Data Quality Gaps

In today's ACT Brief, we examine how shifting patient engagement to endpoint selection improves trial data quality, why execution infrastructure must precede AI deployment, and addressing missing baseline data in real-world oncology research.

September 14th, 2026

ACT Brief: Epilepsy Trial Endpoints, Lab Orchestration and Scientific Intent, and Systems Over Point Solutions

In today's ACT Brief, we examine why seizure reduction misses what families want from epilepsy trials, how lab coordination requires connecting data to intent, and why healthcare needs orchestration rather than more tools.

September 11th, 2026

ACT Brief: Patient Voice in Protocol Design, AI-Informed Recruitment Workflows, and Engagement Maturity Beyond Performative

In today's ACT Brief, we examine genuine patient partnership in trial design, how AI enables informed recruitment while preserving clinician relationships, and moving patient engagement beyond performative gestures.