“Quality needs to be built into every step of the clinical trials process”, insists a leading US Food and Drug Administration (FDA) official.
The ICH GCP definition of 'audit' focuses on compliance assessment, and this is also an expectation of the regulatory authorities. Quality assurance for clinical studies the world over is a critical function. It takes on a greater level of criticality when such studies are conducted in a distant country. Typically, quality of a clinical study is assessed by audits. To ensure consistent quality in clinical trials, it is mandatory to make the quality assurance team an integral part of the whole process, from design to submission of reports. A sound audit plan and process in an organization would not only help the sponsors and CROs to avoid unpleasant surprises, but will enable them to detect and bridge gaps very early in the process.
Used effectively, external audits can reduce costs, maintain project schedules, and ensure regulatory compliance. Independent audit of a clinical trial can bring a fresh perspective and new insights into the study. An external auditor can be more effective than an in house QA in identifying lacunae and calling for any needed changes.