How fragmented systems are quietly slowing down clinical research, and why most organisations don't realise it yet

Walk around Alderley Park, or any of the lab clusters that make up the North's life sciences scene, and you'll find two kinds of company at very different stages of the same problem. The university spinout with a promising molecule or device, about to run its first trial. And the growth-stage company five years on, running trials across several sites, that assumed the operational headache would ease with scale. It rarely does. It just changes shape.

Both groups end up in the same place: more systems than people to run them.

This isn't an abstract problem. Sites must requalify against different sponsor-specific systems and criteria for every new study, and without consistent, shared standards, that process stays fragmented and duplicative (Buse et al., 2023).

How it usually starts

The CRO supplies an EDC for data capture, because that's what they use. Your own team wants budget and site tracking somewhere they control, so a separate CTMS gets set up. The Trial Master File needs a home, and the CRO's eTMF doesn't talk to your systems, so a third platform holds the documents. Recruitment runs through a fourth tool, because that's what was available when you needed it fast. Three months in, whoever's coordinating the trial has a personal spreadsheet tracking which consent form lives where, because none of the four systems agree.

Nobody made a bad call here. Each tool was the right choice at the moment it was chosen. For a two-person operations team at an Alderley Park spinout, or a slightly bigger team at a growth-stage Manchester or Liverpool biotech, that patchwork isn't a minor inconvenience. It's a second, unpaid, full-time job.

Where the days actually go

A monitor visit slips by three days because the eTMF upload and the CTMS sign-off happened in different systems and nobody caught the mismatch until the visit itself. A safety query gets logged once by the CRO and once by your own team, and the two versions drift apart within a week. The enrolment number you report to your board doesn't match the number in the CTMS, and now you're explaining a discrepancy instead of progress, on a trial where every week matters before the next funding round.

Why growing out of it doesn't happen on its own

The common assumption is that this eases once you're past the spinout phase, once you've made a proper operations hire. Usually it doesn't. More studies mean more sponsor-mandated systems layered on top, not fewer, and the two-person problem becomes a five-person problem, still reconciling numbers across tools that were never built to share data. Bigger pharma sponsors absorb that with dedicated headcount. Most of the North's biomedical and medtech companies don't have that slack, and won't for a while.

It looks different depending on where you sit

Spinouts and growth-stage companies feel this as a staffing squeeze. CROs running trials for several of these companies feel it as a lack of standardisation: each sponsor arrives with its own EDC, CTMS and document conventions, and the same monitor relearns a different system stack for every study in a week. University hospitals and academic sites feel something closer to the spinout's version, minus the option to hire their way out of it: a trial often runs on whatever the funder, sponsor or CRO mandates, layered on top of the trust's own systems, and the research nurse coordinating it is doing so alongside clinical duties, not instead of them.

Fewer, connected systems beat more, separate ones

The fix isn't adding a fifth tool. It's collapsing the four into one. When data capture, site and budget management, documents and monitoring sit in a single environment, that consent form has one home, not four possible ones. The enrolment number your coordinator sees is the same one your board sees, because there's only one number to look at.

That's the direction platforms like ResearchManager's Clinical Research Suite are built for: consolidating the full trial pathway, from data capture to site and document management, into one digital environment rather than a collection of tools bought separately as the need arose. For a Northern biomedical or medtech company taking its first or fifth study through to completion, for a CRO trying to standardise across sponsors, or for a research team balancing a trial alongside clinical care, that's less a nice-to-have and more a question of where the hours go.

Curious what this looks like for your own trial setup? Get in touch with Hans at hans@myresearchmanager.com.