Abstract

CONDUCTING CLINICAL TRIAL IN INDIA FOR INVESTIGATIONAL NEW DRUG

*Desale Mayur Sanjay, Desale Madhuri Sudhir, Rathod Sachin Kailas, Patil Pratik Vikasrao

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Abstract

Revelatory Trends in Clinical Research, Clinical data management is a heart and important part of a clinical trials, Due to globalization of clinical trials sponsor needs to meet international standards and strictly comply with regulatory requirements for approvals of new drug application (NDA). Clinical trial operations plays the major role in the drug development process right from the Phase 0 Pre Clinical Studies, Phase 1, Phase II, Phase III and Phase IV Post Marketing Surveillance. The clinical trial operations and clinical data management together encompasses three main stages in the drug development phase. Clinical Study Start Up Phase, Clinical Study Conduct Phase, Clinical Study Close Out Phase.

Keywords: Clinical trial, clinical data management, preclinical phase.