Case Study: Wellcome-HRB Clinical Research Facility achieves 50% reduction in protocol deviations and faster trial growth with Qualio

Reaping the rewards of a new agile quality approach

The Wellcome‑HRB Clinical Research Facility, a partnership between Saint James' Hospital and Trinity College Dublin that runs and sponsors clinical trials, struggled with a paper‑based QMS as it scaled past 40 staff. Monthly reviews, CAPA build/closeout, training tracking, and audit preparation were time‑consuming and error‑prone, with some protocol deviations only spotted by sponsors — prompting the team to evaluate vendors and move to an electronic quality management system (eQMS) from Qualio.

Wellcome‑HRB went live with Qualio in January 2024, using its configurable, user‑friendly eQMS for documents, training, events and analytics; Qualio enabled daily quality reviews, centralized training and collaboration across departments, and faster SOP publication. The results include a 50% reduction in non‑conformances and significant deviations, one week saved per SOP publication (down to 3 days from 10), Phase I trials in the pipeline rising from 1 to 5 (a 400% boost), higher sponsor satisfaction and greatly improved staff engagement — all attributed to Qualio.

Wellcome-HRB Clinical Research Facility

Kishor Santhosh

Quality & Regulatory Affairs Manager