Clinical Research & Clinical Trial Management | Project Owner

On August 25, 2026, FDA's Center for Devices and Radiological Health (CDRH) released a discussion paper seeking public feedback on a regulatory framework for generative AI-enabled medical devices, products built on LLMs and foundation models that produce open-ended, variable outputs and can evolve after deployment. Unlike traditional software, these devices can't be exhaustively tested against a fixed set of inputs and outputs, so FDA is proposing a competency-based approach modeled loosely on how human clinicians are trained and credentialed: a two-stage process combining large-scale "device benchmarking" (testing safety, clinical proficiency, and generalizability against prespecified criteria) with "clinical confirmation" (real-world or clinically representative evidence, ranging from retrospective case review to full prospective trials).  Risk would be assessed via a proposed two-axis framework,  plotting a device's activity level (from passive infor...

Who Actually Funds Hypnosis Research, and Why Isn't Pharma at the Table? A year ago, this blog looked at what's happening in clinical hypnosis research , real trials, registered on ClinicalTrials.gov, showing measurable effects on pain, sleep, and anxiety. Revisiting that ground a year later raises a different question, one the original post didn't ask: who is actually paying for this? The answer, almost without exception, is: not the pharmaceutical industry. And the reason isn't scientific doubt about whether hypnosis works - the evidence base, while still developing, is genuinely there. The reason is economics. The pattern is consistent, and it's not a coincidence Look at the sponsor field on almost any hypnosis RCT and a pattern repeats. The chronic-pain hypnosis trial in cancer survivors cited in our original post was funded by NIH grants through the National Institute of Nursing Research and the National Center for Complementary and Integrative Health, ...

How Many Software Systems Does One Clinical Trial Actually Need? Ask someone outside the industry to guess how many software systems a single clinical trial runs on, and they'll probably say two or three: something to collect patient data, something to manage the study. Ask someone who actually staffs a site, and the answer is closer to twenty. This isn't exaggeration. It's documented, repeatedly, across multiple independent industry surveys. And once you start counting, the financial and human cost of that sprawl becomes hard to ignore. The inventory: what actually runs a trial A realistic multi-site trial typically touches systems across at least six layers: Core eClinical systems EDC (Electronic Data Capture) for patient-level data collection CTMS (Clinical Trial Management System) for enrollment, site performance, milestones, budgets RTSM/IRT for randomization and drug supply management eTMF for trial master file / regulatory document repository eConsen...

Ask most people in clinical research whether a trial protocol is confidential, and the answer comes fast: "Of course it is." Ask a regulator, and the answer is more precise: parts of it are, and increasingly, large parts are not. This distinction matters for far more than curiosity. It shapes how project teams can share documents with vendors, how patients and advocacy groups can review what a trial actually involves, and, as explored in an earlier piece on this blog about protocols and generative AI , what can safely be uploaded into an AI tool in the first place. This article stays deliberately narrower: not the AI question, but the underlying regulatory one. What does the law and GCP framework actually say is public, and what stays behind closed doors? Confidentiality has a formal definition: it's narrower than people assume. ICH's Good Clinical Practice guideline doesn't treat "the protocol" as a single confidential object. It defines confiden...

1. A rapidly growing multi-billion-dollar market Clinical research represents a major and growing sector of the life sciences industry. According to Grand View Research, the global Clinical Trials Market was valued at USD 89.0 billion in 2025 and is projected to reach USD 158.4 billion by 2033 , representing a compound annual growth rate (CAGR) of 7.7% . Within this broader ecosystem, the global eClinical Solutions Market was estimated at USD 11.5 billion in 2025 and is expected to grow even faster, reaching USD 35.1 billion by 2033 with a projected CAGR of 15.1% . References Market (USD) 2025 2026 (Estimate) 2033 Forecast CAGR (2026–2033) Source Clinical Trials Market $89.0 B $94.0 B $158.4 B 7.7% Grand View Research eClinical Solutions Market $11.5 B $13.1 B $35.1 B 15.1% Grand View Research The comparison highlights an important trend. While the clinical trials industry ...