Case Study: Cambridge University Hospitals achieves efficient, compliant clinical-trial record keeping with Q-Pulse from Ideagen

Cambridge University Hospitals NHS Foundation Trust improve record keeping efficiency for their Clinical Trials activities

Cambridge University Hospitals NHS Foundation Trust (CUH), including the Cambridge Clinical Trials Unit (CCTU) and the NIHR Clinical Research Facility at Addenbrooke’s, runs complex, multi‑centre clinical trials that must meet stringent Good Clinical Practice (GCP) and regulatory requirements. A largely paper‑based quality management system made it difficult to maintain up‑to‑date SOPs, training and equipment records, and to respond quickly to MHRA inspections — creating inefficiency and compliance risk.

CUH implemented Ideagen’s Q-Pulse electronic QMS to centralize document control, training logs and equipment maintenance/calibration records. The system now manages 669 active documents, 609 superseded documents, ~82,000 electronic signatures, 3,227 training events and 270 active equipment records, enabled instant retrieval of historical records, supported flawless MHRA GCP inspection results (zero non‑conformances) and helped secure CCTU registration with the UK Clinical Research Collaboration network.

Cambridge University Hospitals

Carolyn Sexton

Quality Assurance Manager