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Aditi Hazra
QA Auditor
Aditi Hazra, BSc, MSc, is a clinical research professional with 10 years’ international experience in the clinical research industry providing auditing and process improvement services to pharmaceutical companies and CROs throughout SE Asia and is based in India.
Aditi spent 6 years with Pfizer as a lead CRA, training coordinator, clinical study manager and CRA line manager for the regional monitoring group. Aditi has headed clinical operations for a leading Indian CRO and has recently worked as Clinical Quality Assurance auditor for Johnson & Johnson, responsible for the Asia-Pacific area. In this role, she completed audits spanning Phase 1, 2 and 3 global trials at sites in SE Asia including participation in a pre-inspection readiness; US FDA inspection visits in India; and systems compliance audits. Aditi has worked most recently as an Independent Auditor on behalf of a variety of clients involving GCP audits of sites and CROs in the SE Asia region.
‘Quality is an integral part of clinical trial conduct; the only way to achieve it is by process excellence. GCP is common sense but implementing and adhering to it requires immense effort. The key challenge in ensuring quality in clinical trial conduct in Southeast Asia is the disconnect between the routine clinical practices followed and the level of documentation that GCP demands. Once that gap is bridged, quality of trial conduct will automatically improve’
