“Quality needs to be built into every step of the clinical trials process”, insists a leading US Food and Drug Administration (FDA) official. While working in Pharmaceutical industry, our department often felt the need to outsource GCP audits either due to resource constraints or because of specialized skills. We were always looking out for an agency who is dedicated into this space rather than outsourcing it to a CRO who offer QA along with other services. With large CROs, there were occasionally conflict of interest issues. It was seen that most of the CROs were uncomfortable to be audited by a competitor CRO. Furthermore, every CRO and Pharma company has a QA unit but to do a reality check of their own systems and procedures, they need to be evaluated by some external auditor who could give them an holistic view of how they can do better. 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. 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.

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