Clinical Research & Clinical Trial Management | Project Owner

From study-specific data collection and fragmented systems to a research platform supporting clinical trials, routine care and longitudinal research. 1. The traditional clinical research model Clinical research has traditionally been organised around a defined study and a specific research question. A medicinal product or treatment is investigated according to a protocol, with specified eligibility criteria, patient populations, endpoints, assessments and observation periods. Depending on the research question and development stage, this may involve Phase I, II and III clinical trials, randomisation, control groups and double-blind designs. Patients are recruited, data are collected, results are analysed and conclusions are drawn. Once the study is completed, its formal research activities come to an end. This model has been fundamental to the development and approval of medicines. It provides a controlled framework for assessing safety and efficacy. However, it also creates a separati...

When health advice becomes advertising, who is responsible for protecting the consumer? A November 2025 article in Regulatory Focus by Angela Clausen and Sabrina Göddertz examines influencer marketing of food supplements in Germany and the challenges it creates for consumer protection. The authors highlight three recurring problems: advertising that is not clearly identified, health claims that may not comply with EU rules, and dosage recommendations that can expose consumers to unnecessary risks. Their review also points to a practical enforcement problem: national authorities often struggle to monitor the volume and speed of social-media content. The regulatory framework already includes EU rules on food information, health claims and digital services. The challenge is making these rules effective in an online environment where influencers can reach large audiences, promote their own products and communicate directly with consumers. The authors call for stronger EU-wide regulation, ...

A Project Management Song from the Multiverse.  What do you do when a project is three weeks behind schedule?  https://www.youtube.com/shorts/GpSIOkmdrq0 Song on Suno AI :  https://suno.com/song/0b5c5257-8860-4cf9-914e-71d4af68fb46 New Physics of Project Management [Verse 1] Milestone slipping, three weeks behind Budget alarms going off down the line “Cut the scope,” they say - but wait, don’t touch the plan There’s a new physics now - reverse it if you can [Chorus] Time machine in the multiverse Make your project green, erase the curse Don’t touch the scope, don’t touch the cost Just shift the timeline - nothing’s lost [Verse 2] Dashboards are golden, the invoice looks clean On paper we’re winning, right on the scene But somewhere out there, real time still flows And the deadline’s waiting - no matter what the chart shows [Chorus] Time machine in the multiverse Make your project green, erase the curse Don’t touch the scope, don’t touch the cost Just shift the timeline - ...

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...