Elevating compliance and achieving elite research status

Introduction

The Cambridge Clinical Trials Unit (CCTU) at CUH supports academic investigators in conducting high-quality clinical trials, contributing to groundbreaking advancements in healthcare. As part of the Addenbrooke’s Clinical Research Center (ACRC), CUH plays a pivotal role in clinical research across a wide range of medical specialties.

To maintain their competitive edge and ensure compliance with stringent regulatory standards, CUH needed to transition from a cumbersome paper-based Quality Management System (QMS) to an efficient electronic solution.

The challenge

• The Trust’s paper-based QMS was inefficient, making it difficult to manage the large volume of mandatory documentation required for compliance with GCP.
• SOP documentation, training records, and equipment management were all manually handled, leading to potential delays and inaccuracies.
• Regulatory inspections, such as those by the MHRA, required swift access to documents and records, which was a challenge with the existing system.

Finding the right solution

The Trust selected Ideagen for its ability to centralize and streamline the management of SOPs, training records and equipment maintenance.

The user-friendly interface of the solution enabled the team to implement a more efficient system that met their compliance needs.

Additionally, Ideagen’s robust document management capabilities were crucial in ensuring that all required records were readily accessible during inspections.

Implementation and impact

• The implementation transformed CUH’s operations, with over 82,000 electronic signatures, 3,227 training events, and 270 equipment records now centralized in the system.
• Staff gained immediate access to critical SOPs and documents, drastically improving the efficiency and accuracy of daily operations and compliance activities.
• Ideagen played a key role in CUH securing UKCRC registration, a significant achievement that solidified their position among the UK’s top research institutions. This registration recognizes the Trust’s commitment to high standards and opens doors to further research collaborations and funding opportunities.