Abstract

"Compliance - A New Jargon in Clinical Research" - A Sponsor Perspective

Radhika Inapakolla, Asst. Director, Lupin Limited

Clinical Research has become increasingly cautious about regulatory compliance, with the heightened scope of compliance requirements. The quality, as judged by many regulatory inspections of the investigator sites, sponsors/contract research organizations and Institutional Review Board, has become a core focus for the inspectors to give an insight on understanding of Compliance by these different stake holders. In recent times there were a lot of deficiencies and non GCP practices identified and caught which are on a common grounds of fraud and misleading the study conduction.

This led FDA in developing new approaches of risk-based inspection planning. To help implement new risk management approaches, CDER reorganized Office of Compliance (OC) to create the Division of Compliance Risk Management and Surveillance.

To meet the regulatory expectations, the sponsors need to improve and demonstrate quality and integrity of data by developing systems such as compliance team/ data integrity cell which is above quality assurance.

Although the inception of quality systems was to mitigate compliance risk, clinical quality systems within the GCP framework are now not adequate as per the expectations of regulatory bodies due to constant changes in perception of inspectors.

The goal of compliance program is to promote operational excellence, best practices, and regulatory compliance in clinical research where sponsors need to hold the ownership of end-to-end from strategic designing through regulatory reliance of scientific sanctity, safe and efficacious product consumption.