"Data Integrity in Clinical Research – Quadruple Face-off” – A Sponsor Perspective
Ravisekhar Kasibhatta,
Senior Vice President,
Lupin Bioresearch Center
Clinical research requires diligent and vigilant documentation. All procedures adopted in the conduct of clinical trial should be complete and accurate. Data integrity is considered to stand against the test of science, regulatory and time only when the stored data / source documentation is able to “re-create” the conducted research. Globally several pharmaceutical companies and CROs have faced regulatory ire due to inadequacy and poor data quality. In clinical trial process, there is a need for proper planning and checks from the point where data is generated through good data management and good reporting practices; and also risk based monitoring tools ensuring the data supports integrity of research outcome without an iota of doubt. Both sponsor / CRO should join hands to mitigate such insulting confrontations by addressing the key attributes like training gaps, genuine human errors, inadequacies, falsifications and omissions etc., by all stakeholders.
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