In today’s ACT Brief, we examine what it will take to scale EHR-to-EDC connections for real-time trials, how the FDA is reimagining rare disease drug development, and why oncology real-world evidence still faces persistent data barriers.
News|Podcasts|September 24, 2026
ACT Brief: Data Provenance and Device Strategy, Cell-Gene Therapy Site Readiness, and Data Harmonization Bottleneck
Author(s)Andy Studna, Senior Editor
In today's ACT Brief, we examine why defensible trial data depends on traceability and platform ownership, what CGT site readiness requires as therapy moves to community care, and why data harmonization is AI's primary bottleneck.
This is the Applied Clinical Trials Brief—your fast track to the latest insights shaping clinical operations and drug development.
- In the
latest Beyond Compliance episode , Cecilia Xi, PhD, VP of clinical and scientific affairs at Vivalink, explained why defensible trial data depends on traceability across both time and space, tracking how raw device output moves through to final datasets. She stressed that sponsors cannot outsource accountability for their data, even when vendors do the collecting, and urged early transfer to sponsor-controlled repositories to prevent data loss if vendor relationships end. - In a
new feature article , Mark Sawicki, CEO of Cryoport, examined how cell and gene therapy site readiness now encompasses ISO 21973-aligned processes, cryogenic infrastructure, pharmacy handling, and 24/7 monitoring. As CGT access expands into community care beyond academic medical centers to reach the 80 percent of patients who cannot currently access these therapies, operational coordination and supply chain standardization become first-order priorities equivalent to manufacturing capacity. - In a
new contributed article from Pharmaceutical Executive , Partha Anbil and Satish Tadikonda examined why clinical data harmonization is the real bottleneck between AI's potential and AI's impact, with 92% of AI-powered clinical trials still relying on legacy data standards designed for humans, not machine learning. Agentic AI orchestrators that autonomously ingest data from diverse sources, detect privacy concerns, and run quality rules before analysis begins are shifting pharmaceutical companies from reactive AI tools toward AI as a genuine partner in data preparation.
That's all for today's ACT Brief. Join us tomorrow for more updates shaping clinical operations and drug development. Thanks for listening.
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