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International Clinical Trials

The Importance of CDMS in the Clinical Study Process

A Clinical Data Management System (CDMS) is a tool that stores data from clinical trials conducted at investigator sites. This tool is vital for ensuring clinical trial data quality, regulatory compliance, managing a global scale, and accelerating time-to-trial completion. Case report forms (CRF), which include the data collected at the clinical trial sites, are manually stored in a CDMS. However, manual entry poses a high risk for typographical errors. Therefore, clinical investigators should capture data via electronic case report forms over paper-based CRFs. Doing so helps avoid mistakes and better orchestrate data entry and transmission.

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About the Authors

Rohit Jain is an experienced IT consultant with over 15 yearsí experience in data management consulting and implementation. His focused expertise includes CDM, master data management, data quality, and governance within the pharma industry. Rohit has successfully led global programmes to deliver CDM and master data management solutions. Such applications include a global CDM solution for one of the top 50 global pharma companies and multi-domain master data management for one of the top three US food and distribution companies. Currently, Rohit is a director at Axtria, Inc., with a Masterís degree in Computer Applications and a Postgraduate diploma in Business Administration.

Rebecca Lorenzo is a digital content creator with over seven years of experience in marketing, journalism, content strategy, and social media management. Rebecca works both independently and in partnership with life science subject matter experts to create content about data analytics, artificial intelligence, pharmaceuticals, and much more. She is experienced in creating articles, videos, graphics, and everything in between. Currently, Rebecca is a Marketing Analyst at Axtria, Inc. In her free time, she is a highly acclaimed writer and director for a music news publication. She holds a Bachelorís degree in Communications and a Minor in Literature.
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