Managing Clinical Trials: Meet GCP Guidelines with Cognidox

Clinical research demands strict GCP (Good Clinical Practice) compliance. But many institutions stuck with outdated, paper-based systems are struggling to digitise efficiently and meet the regulations.

This case study tells the story of how the Newcastle Cancer Centre Pharmacology Group (NCCPG) managed their digital transformation differently with Cognidox. 

Background

In 2021, the Newcastle Cancer Centre Pharmacology Group (NCCPG) were looking to simplify their workflows and improve clinical trials processes whilst still fulfilling their regulatory requirements with clinical trials.

The team had faced a number of pressures as they worked out how to bring their clinical research documentation into one digital hub:

• A cyber-attack in 2020 had compromised access to internal electronic systems, making them inaccessible.
• Existing IT could not support FDA and MHRA compliant digitisation.
• 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 system they could use as an:

• Electronic Trial Master File/Investigator Site File.
• Electronic laboratory notebook.
• Document control system (for all controlled forms and SOP’s).

A demo of the Cognidox eQMS instantly showed the team how it could be used to digitise documentation and meet regulatory requirements. 

Crucially, it offered a robust framework for compliance that could be both flexible and bespoke. It promised to accelerate their process and prepare them for future digital audits.

Cognidox’s ‘no code’ approach - made configuration simple

Using the platform, , NCCPG staff could easily customise forms, create the file structures and impose document controls that could meet GCP guidelines. They quickly digitised their:

• Electronic lab books
• Case Report Forms (CRF)
• 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.

Cognidox was used to structure and manage complex clinical trial documentation - using bespoke forms and workflows to capture required data.

2. Ensuring GDPR Compliance through Data Segregation. 

The team run 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.

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, across clinical trials that can take years to complete. 

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.