Critical to Quality Assessment Methodology: An Adaptable Clinical Trial Risk Management and Quality Assurance Approach for Quality Functions in Pharmaceutical Companies.

Overview

This paper introduces the Critical to Quality Assessment Methodology created by the IMPALA consortium, offering an adaptable, risk-based quality management approach for clinical trials. The methodology utilizes both traditional and analytical methods to continuously generate quality evidence, ultimately documenting Good Clinical Practice compliance conclusions in a Critical to Quality Assessment Report (CAR) for stakeholders.

Details

May 2026 – Therapeutic Innovation & Regulatory Science

Authors: Kiernan Trevett · Jennifer Emerson  · Paula Walker  · Timothé Ménard  · Mariza Koukounari  · Louise Anderson  · Heike Barlow  · Jamie Bridges  · On behalf of the IMPALA (Inter coMPany quALity Analytics) Consortium.