Abstract

THE EVOLUTION OF THE ROLE OF A CLINICAL DATA MANAGER

Sharad Sharma*, Shivaji Bote (SME-CDM) and Dr. Jonathan DSouza (SME – Patient Centricity)

Abstract

In the present day scenario, a major requirement of the pharmaceutical industry is to bring the newly discovered drug faster to the market with regulatory approvals. With this challenge, the role of a Clinical Data Manager (CDM) has become very important as they are the ones responsible for the management of clinical data collected from various trials spanning different phases and therapeutics areas, its validation, reconciliation and cleaning. For all trials, the Clinical Data Managers are involved from the initial phase and provide inputs that will help in the collection, analysis and interpretation of data. They play a key role during the study setup, conduct and close-out activities of any trial, along with vendor management activities. Evolution of new technologies such as transition from paper to Electronic Data Capture (EDC), data standardization e.g. Clinical Data Acquisitions Standards Harmonization (CDASH), Submission Data Tabulation Model (SDTM) has not only helped reduce the time taken to perform Data Management activities but has also reduced the trial cost. This technology evolution has also led to the evolution of the traditional CDM role.

Keywords: Clinical data manager, clinical data management system, CDISC, risk-based monitoring (RBM), clinical research, skillset.