This case study tells the story of how the Newcastle Cancer Centre Pharmacology Group (NCCPG) managed their digital transformation differently with Cognidox.
The NCCPG story at a glanceThe challenge:
The Solution: Cognidox offered a flexible 'no-code' document control solution for electronic trial files, laboratory notebooks, forms and SOPs - compliant with MHRA guidelines and FDA CFR part 11. Cognidox in action: NCCPG used Cognidox to speed up patient registration, enhance data management, and impose end-to-end document control. Results: Cognidox accelerated clinical trial management, streamlined risk management and offered full, digital auditing capabilities - at a fraction of the cost of traditional clinical trial software. How Cognidox supports clinical trials: Cognidox offers a user-friendly, web-based platform that centralises documentation, ensuring organised, efficient management and global accessibility. It prioritises security and compliance with features like unique user sign-ons and FDA compliant e-signatures, mitigating data integrity risks. The system’s customisable structures and efficient document handling streamline processes, while robust document control and private workspaces facilitate secure, compliant collaboration. Cognidox effectively manages complex trials from registration to approval in line with MHRA requirements. The platform provides configurable online forms and organised email storage, making it a comprehensive, efficient, and secure choice for clinical trial documentation management. |
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:
The NCCPG needed a system they could use as an:
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.
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:
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.
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.
Cognidox’s sub-categories store all data securely - and make it easy to organise, review and systematically approve.
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:
Powerful document control tools accelerate NCCPG lab work and mitigates the risks of errors in document handling:
Recommended titles within Cognidox allow automated file naming to ensure documents cannot be lost or misfiled.
Permissions hierarchy prevents unauthorised editing and sharing.
Cognidox ticks all the boxes for GCP and ALCOA++ (ensuring lab data is Attributable, Legible, Contemporaneous, Original, Accurate, Complete, Consistent, Enduring and Traceable).
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.
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.