Why setting up a clinical trial still feels like starting from scratch every time
Why setting up a clinical trial still feels like starting from scratch every time
Ask a study manager how their last trial began, and the answer is rarely “we picked up where the last one left off.” Even organisations that have run dozens of studies tend to start each new one the same way: contracts negotiated from scratch, systems configured from zero, processes documented as if for the first time. The UK research system has made real progress on one part of this problem. The National Contract Value Review (NCVR) and its model agreements replaced site-by-site contract negotiation with a standardised national approach, cutting the costing and contracting stage of study set-up from around ten months to six (Nicholson, 2023). That's a genuine improvement, but it also exposes how much of the rest of study set-up still gets rebuilt every time.
What standardisation actually covers
NCVR and the model Clinical Trial Agreement address one specific layer: the cost and contract terms between sponsor and site. That layer once required independent negotiation with every site on every study, and removing that duplication was worth the effort. Unmodified use of the model agreements now removes site-by-site review almost entirely, a principle the Health Research Authority describes as enabling “no local contract-value negotiation” (Nicholson, 2023). But NCVR covers costing and contracting only. It doesn't extend to the systems and processes a research team uses to actually run a study day to day.
The parts nobody standardised
Every new study still typically needs its own data capture setup, configured for that protocol, and its own local habits for tracking who signed what and when. The Trial Master File is a partial exception: ICH-GCP and the TMF Reference Model standardise what it must contain, but not the system used to build and maintain it. This duplication isn't anecdotal. In an HRA survey of 521 people working across UK health and social care research, 59% reported unnecessary duplication or steps in study set-up, and commercial sponsors rated the process's efficiency lowest of any group (Health Research Authority, 2025). None of that sits within reach of a national contracting standard.
What reusable infrastructure changes
The alternative isn't another national standard to negotiate. It's treating the operational layer of a study the way NCVR treats the contractual layer: built once and reused, not rebuilt every time. A modular, configurable platform lets a team reuse the same data structures, document workflows and user permissions across studies, adjusting only what a new protocol requires. What used to take weeks of local configuration becomes a matter of adapting an existing environment rather than assembling a new one. The result isn't just faster set-up. It's a research organisation that gets structurally faster with every study it runs, because the infrastructure underneath the work is reusable rather than disposable.
At ResearchManager, this is exactly the gap our platform was built to close. Our Clinical Research Suite is designed as reusable infrastructure, not a one-off build: the same modular, configurable environment carries over from study to study. If starting from scratch feels familiar in your organisation, we're happy to see if we can help.
Find us at my-researchmanager.com/en/ or contact Hans (hans@myresearchmanager.com).
References
Health Research Authority. (2025). Study set-up at site: our survey results. HRA. https://www.hra.nhs.uk/planning-and-improving-research/improving-research/our-work-part-ukcrd-streamline-and-reform-study-set-/study-set-up-at-site-our-survey-results/
Nicholson, A. (2023). Blog: How NCVR has helped accelerate study set up in the UK. Health Research Authority. https://www.hra.nhs.uk/about-us/news-updates/blog-how-ncvr-has-helped-accelerate-study-set-uk/
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