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Managing clinical trial documents manually can be a major headache. From consent forms to sample tracking logs, sites are under pressure to digitise their paperwork. They need to save time, reduce risk, and simplify audits, while ensuring they’re always watertight on MHRA and FDA compliance. But how can they manage that balance?
Here’s how one UK university transformed their clinical trial document management - keeping regulators happy, their team productive, and their budgets intact.
In 2021, the Newcastle Cancer Centre Pharmacology Group (NCCPG) were looking to create a more frictionless documentation process to reduce time spent on admin and audit preparation.
The team faced a number of pressures as they worked out how to bring their clinical research documentation into one digital hub:
- Existing IT could not support FDA and MHRA requirements
- A cyber-attack in 2020 had compromised access to internal electronic systems,
- Post-Covid hybrid working was slowing down approval processes.
- Automation was needed to rationalise the way they worked
- Most eTMF (Electronic Trial Masterfile) solutions were expensive and inflexible
Cognidox offered a practical and flexible solution
The NCCPG needed a single, flexible system that could serve as:
- An Electronic Trial Master File (eTMF) and Electronic Investigator Site File (eISF)
- An Electronic Laboratory Notebook (ELN)
- A Document Control System for managing controlled forms and SOPs
After a demo of the Cognidox Document Management System — already widely used across the med tech sector — the team saw its potential.
Cognidox offered a powerful yet easy-to-configure platform that enabled real-time version control, decentralised collaboration, and full GCP compliance. It provided a single digital hub for documentation, simplifying audit prep and ensuring inspection readiness.
Crucially, Cognidox delivered all this at a fraction of the cost of traditional clinical trial software—without compromising compliance or control.
How to manage clinical trial documents electronically
Using the Cognidox platform NCCPG staff could easily customise forms, create the file structures and impose document controls that could meet GCP guidelines. With the new tools, they quickly digitised their:
- Investigator site file
- Case Report Forms (CRF)
- Electronic lab books
- Accountability logs
- Risk assessments
- Equipment calibration
- COSHH forms
- Training forms
- Instrument logs
- Clinical trial data
How NCCPG used Cognidox to manage clinical trials
1. Completion of clinical trial data by remote data entry
Registering patients for clinical trials with paper forms can be time-consuming and laborious.
Managing and sharing data without the right digital tools risks losing information and compromising security.
With Cognidox the NCCPG were able to structure and manage their electronic Investigator Site File (eISF) using bespoke forms and workflows to capture required data.
2. Ensuring GDPR Compliance through Data Segregation.
The team runs trials across multiple locations throughout the UK, with separate and secure log-ins for each user and private work spaces for each site to complete forms and make other submissions. Each location has its own private digital workspace so data cannot be misfiled or viewed by anyone outside of the workspace.
3. Document organisation (including electronic Trial master files/Investigator Site files)
Cognidox’s sub-categories store all data securely - and make it easy to organise, review and systematically approve.
4. Document approval and authorisation
Cognidox handles all the e-signature authentication protocols and ‘manifests’ required for FDA 21 CFR Part 11 and MHRA approval. This makes managing multiple approvals for clinical trial documentation simple:
5. Automated document control and audit trail
Powerful document control tools accelerate NCCPG lab work and mitigates the risks of errors in document handling:
6. Standardising document nomenclature
Recommended titles within Cognidox allow automated file naming to ensure documents cannot be lost or misfiled.
7. Access control and security
Permissions hierarchy prevents unauthorised editing and sharing. The system is ISO 27001 compliant to ensure the highest levels of data protection.
8. Data integrity
Cognidox ticks all the boxes for GCP and ALCOA++ (ensuring lab data is Attributable, Legible, Contemporaneous, Original, Accurate, Complete, Consistent, Enduring and Traceable).
9. Paper free auditing and direct access
All documentation and data are structured and indexed in a single digital hub. Cognidox is integrated with Office and Outlook, ensuring email exchanges are part of every audit trail.
This has made internal and external auditing much more straightforward. Inspectors/auditors can be given limited access to information from Electronic Lab Books, maintenance records, and clinical trial data through the secure, Cognidox interface.
Inspectors/auditors can see what was approved, by whom and when, even across clinical trials that can take years to complete.
Summary: How Cognidox accelerates clinical trial documentation
The Challenge:
The NCCPG were struggling with paper-based documentation and the inefficiencies of wet ink signatures.
The Solution:
Cognidox delivered a flexible, no-code document control platform for building an eTMF and eISF, with lab notebooks, SOPs, and forms - fully compliant with GXP guidance and FDA CFR Part 11.
Cognidox in action:
At NCCPG, Cognidox was used to accelerate patient registration, improve data integrity, and implement robust, end-to-end document control across the trial lifecycle.
The Results:
Faster trial management, simplified risk handling, and complete audit readiness—all at a fraction of the cost of traditional clinical trial software.
Conclusion
Cognidox helped the NCCPG control their laboratory documentation and manage clinical trials in a much more efficient way. It has saved them huge amounts of time, resource and paper filing while cutting the risk of non-compliance.
The team didn’t need to access expensive and inflexible clinical trial software to meet GCP guidelines and MHRA requirements. Instead, they have managed to configure a robust digital system that exactly meets their GCP needs in a highly targeted and cost-effective way.
Blog post updated on 15/04/2025
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