Role Of Medical Data Management Services and Medical Affairs Services

Clinical data management is a multidisciplinary process which involves collection, integration and validation of clinical trial info in accordance with regulatory standards. It plays a crucial role in clinical research and generates high-quality, reliable, and statistically sound data. CDM also reduces the time frame between drug development and marketing. The primary aim of CDM process is to produce high-quality detail with minimal error rate. CDM process encompasses Case Report Form (CRF) designing, CRF annotation, database designing, data-entry, data validation, discrepancy management, medical coding, data extraction, and database locking.

Several software tools are available for managing clinical trial data and these are called Clinical Data Management Systems (CDMS). Commonly used CDM tools are ORACLE CLINICAL, CLINTRIAL, MACRO, RAVE, and eClinical Suite. Among the open source tools, the most prominent ones are OpenClinica, openCDMS, TrialDB, and PhOSCo. These CDM software are available free of cost and equally good as their commercial counterparts in terms of functionality.

The CDM tools also enable to maintain audit trail of medical data management activities during the clinical trial and thereby help in avoiding discrepancies. Multiple user IDs can be created for each team member with the help of these tools. This assures access only to the function allocated to each user ID and does not allow any other changes in the database. In cases where changes need to be made in the data, the software will record the change made, the user ID that made the change and the time and date of change, for audit purposes (audit trail).

It is mandatory to follow good practices in CDM and the electronic records have to comply with Code of Federal Regulations (CFR), 21 CFR Part 11.
Presently, best CDM practices have evolved due to the increasing demands from pharmaceutical companies as well as from regulatory authorities in order to generate high quality data. On the other hand there has been a shift from the paper-based to the electronic systems of data management. There has been a positive influence of technology development on CDM process and systems. CDM should be evaluated through systems that have been put into practice.

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Bhaskar Chandra has published 5 articles. Article submitted on October 03, 2013. Word count: 351

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