FDA's Real-Time Clinical Trials

On April 28, FDA Commissioner Marty Makary stood at a whiteboard and announced the first real-time clinical trial. Two trials are already streaming validated signals to the agency. The platform delivering those signals is a cloud-native software company, not a legacy CRO.

Here is what most of the industry coverage has missed: the technology is not the story. The system pulls structured and unstructured data directly from electronic health records, runs FDA-defined criteria at the source, and transmits aggregated signals to the agency. Block-sequential design. Pre-agreed endpoints. No raw patient records leaving the sponsor environment.

Every other regulated industry solved this a decade ago. Financial services, hospital networks, federal agencies all run on the same architecture. The clinical trials industry kept calling eCTD and eSTAR "digital transformation," when it was really just digital paper. The real conversation is about liability, organizational design, and what happens to the CRO economy when the data layer gets unbundled from the people layer. That is what this roundtable is about.

What You'll Walk Away With

You'll understand	Specifically
What FDA actually built	The technical reality of the proofs-of-concept. Block-sequential design, aggregated signal transmission, what the dashboard FDA reviewers see in real time.
Why no large CRO led this	Innovator's dilemma economics, labor-hour P&Ls vs. SaaS economics, and why FDA chose a cloud-native software partner instead of a legacy CRO.
The liability conversation	Part 11, HIPAA, and the unsettled question of who owns the risk when a clinical trial runs on cloud infrastructure. Why this matters more than the technology itself.
What it means for medtech	RTCT is pharma-only at launch. But imaging endpoints, device performance logs, SaMD telemetry, and post-market surveillance streams map directly onto the same playbook. Sponsors who pre-invest run ahead of the regulatory pace.
The May 29 RFI as positioning	Comments on Docket FDA-2026-N-4390 are public and the record will be cited. We will discuss how non-pharma, non-oncology, and non-survival-endpoint sponsors should be making themselves visible right now.

Your Panel

Angela Johnson, PhD, MSE, RAC, PMP, CPGP

Senior Vice President, Advisory Services | Avania

25+ years directing regulatory and AI/ML programs across medical devices, biopharma, and translational clinical research. Former senior leader of GE Healthcare's machine learning and deep learning programs for medical imaging within GE's Global Research Organization, the most FDA-experienced AI medical device manufacturer in the industry. Two-time GE Healthcare AI Hackathon winner with hands-on work applying NLP to cardiac signal detection. Recipient of the 2017 American Journal of Neuroradiology Lucien Levy Best Research Article Award as a co-author of the MAGiC multicenter trial, the foundational clinical validation of synthetic MR imaging. Principal lecturer in regulatory and biotech business strategy at Northeastern University.

Acacia Parks, PhD, MBA, RAC

VP, Regulatory Compliance & Engineering | Avania

15+ years at the intersection of clinical science, regulatory strategy, and digital health product development, with deep specialization in Software as a Medical Device (SaMD), digital therapeutics (DTx), AI/ML-enabled devices, and clinical decision support systems. Former Chief Scientist at Happify Health, leading a 25-person science team across RCTs and HEOR studies. Has led multiple SaMD products through the full regulatory lifecycle from product concept to marketing authorization, and post-market compliance. Led the Digital Therapeutics Alliance US Policy Group and authored certification criteria for the inaugural DTx Certification program.

Jeremiah Perez, PhD

Principal Biostatistician, Biostatistics | Avania

12+ years designing and analyzing clinical trials and diagnostic studies, with deep methodological expertise in adaptive designs, group-sequential trials, Bayesian methods incorporating historical data, and multi-reader multi-case ROC studies for AI device validation. Former Summer Research Fellow at the FDA Office of Biostatistics (CDER), where he worked on cardiovascular safety outcome trials. Independent statistician on multiple DSMB and Data Monitoring Committees including chairperson roles, interpreting interim results for safety concerns and adaptive study designs.

FDA Just Got an AWS Tunnel.The Industry Is Calling It Revolutionary.

FDA Just Got an AWS Tunnel.
The Industry Is Calling It Revolutionary.