Why UK Clinical Trial Units (CTUs) Are Ditching Paper TMF Systems

Clinical Trial Units (CTUs) have long supported universities and hospitals in delivering the research that transforms healthcare. Managing data, documentation, and process was their bread and butter - and for years, paper systems got the job done.

Until they didn’t.

How paper systems reached their limit

As trials became larger, more complex, and increasingly digital, the paper model of compliance started to creak. Tracking document versions, chasing wet signatures, and updating regulatory binders became a daily battle - a system built for a different era.

“In the clinical trial world, if it isn't documented, it didn't happen. In a paper-based system, you have to keep every single piece of paper - every email that comes in has to be printed. Our Trial Master Files were typically 50 or more lever arch files long."

 Julie Errington, Clinical Trials Analyst/Coordinator, NCCPG

The breaking point

Then came COVID-19, and everything stopped:

“Everyone was working from home - you couldn’t print, we didn’t go into the office for 18 months. People were literally booking time to go in and just print and file. We were burning through boxes of paper for days. It just wasn’t sustainable.”

Julie Errington, Clinical Trials Analyst/Coordinator, NCCPG

That moment exposed what many CTUs already knew: manual systems were holding research back - and the digital tools they had wouldn’t survive much longer in a future of hybrid work.

COVID may have been a catalyst for change. But the problems with maintaining a manual process now stretch way further than the pressure of a shift in working patterns.

The research workforce is shrinking

Rising trial complexity, staff shortages, and expanding regulatory demands mean CTUs must now deliver more, faster, and often with no increase in resources.

The UK’s clinical research workforce has shrunk in both absolute and relative terms, creating new pressures on CTUs to modernise and automate their operations.

Meanwhile, the government’s target to reduce trial setup times to 150 days or less has introduced a new operational imperative: speed. The drive for efficiency is being felt across the sector.

New financial pressures are emerging

The financial stakes are high: clinical trials contribute £7.4 billion annually to the UK economy, and generate around £1.2 billion for the NHS.

But CTUs are being asked to extend their financial and strategic value. NHS England now advises boards to treat research as a source of income, with oversight of “research delivery and the income it generates.”

New regulation is coming soon

The UK’s clinical trials regulation reform, due to be implemented soon, promises faster approvals, proportionate oversight, and a more agile, risk-based approach. But these reforms also bring additional expectations for transparency, data reporting, and digital record-keeping.

In this new regulatory environment, paper systems and partial digitisation will no longer be enough. CTUs need the tools to work in a digital-first ecosystem - where audit trails, approvals, and data integrity are built into daily workflows.

Why CTUs struggle to find the right eTMF solution

The move to digitise with clinical trial management software and electronic Trial Master File (eTMF) systems may feel inevitable, but for many UK CTUs, finding the right solution is anything but straightforward.

Small, agile teams are often overwhelmed by platforms designed for global pharmaceutical companies and CROs. These systems are built for high-volume, commercial drug development - not for academic units.

As one clinical trial lead at a major university research unit told us:

“We are not a CRO running cut-price, commercial drug trials. We need flexibility. Every trial we conduct looks a little different - one might be repurposing an existing drug, another comparing surgical techniques, or even designing a digital application. Systems that force a single rigid structure for every study restrict us rather than liberate us.”

CTUs need digital systems that help them set up and manage their Trial Master Files in ways that fit their workflows, while maintaining full GCP and MHRA compliance.

They must be able to document every step of their process - from risk assessments and consent forms to clinical data and training records - with complete data integrity and traceability built in.

Big eTMF vendors can support this on paper, but they often do it in ways that add layers of bureaucracy, slow teams down, and require months of training to get right.

Instead, CTUs need flexible software that non-coders can configure and operate :

• Intuitive workflows that make it easy to launch new studies and structure digital documentation
• Consistent digital forms approved remotely, and fully compliant with MHRA Annex 11 — recording who signed, when, and why.
• Document and record control built on ALCOA+ principles of data integrity
• Audit-ready design, so MHRA inspectors can instantly reconstruct the decision-making process and see exactly what was approved, by whom, and when.

The complex platforms sold to CROs are often overwhelming for small and agile CTUs. However, achieving and maintaining this level of document control can be challenging with a self-built SharePoint solution.

A flexible digital solution for CTUs

Into this mix comes the Cognidox platform - an eQMS system now being adopted by CTUs around the country to meet the need for flexible, cost-effective trial management software.

Clients such as the Newcastle Cancer Centre Pharmacology Group (NCCPG), which runs multi-site clinical trials, have used Cognidox to build digital forms and workflows that have helped them move seamlessly from paper-based to fully digital documentation.

They’ve accelerated their working process while improving compliance capabilities:

Importantly, the Cognidox platform can be used during inspections to instantly locate and retrieve records. Its powerful search and indexing tools allow inspectors - and CTU teams - to find the exact document, version, or approval trail they need within seconds.

As more CTUs move to digital systems, solutions like Cognidox will be vital to help meet rising regulatory and commercial demands.

Simon Roberts, Sales Director at Cognidox, is seeing this shift gather pace across the UK.

"Many of the UK’s 52 CTUs are still operating on paper or partly digital systems. The transition to eTMF solutions is inevitable, but every unit is trying to strike its own balance between compliance, cost, and culture. Over the next couple of years, that shift will accelerate, and we are here to help meet those needs."

Simon Roberts, Sales Director, Cognidox

For CTUs, the direction is clear. As trials grow more complex and oversight tightens, digital systems that deliver flexibility, control, and affordability will shape the future of clinical research.