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Abstract


IJRDPL - Vol 6, issue 1 (2016), December - January

Pages: 2467-2473

ELECTRONIC TRIAL MASTER FILE (eTMF) - AN INDISPENSABLE TOOL THAT COLLECTS AND FILES ESSENTIAL DOCUMENTS OF A CLINICAL TRIAL: A REVIEW

Author: Raju Sama*, Vijaya Lakshmi N and Suresh A

Category:

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Abstract:

Every organization involved in clinical trials in the BioPharma industry maintains a trial master file comprised of thousands of pages of regulatory documents required for each clinical trial. Managing thousands of clinical documents, tasks and processes using a paper-based or hybrid trial master file system can be overwhelming and can introduce errors and oversights that put your clinical trial at risk for noncompliance. An Electronic Trial Master File provides an industry best practice approach to document management which allows you to gain the insight you need to efficiently manage clinical trials and accelerate time to market. In order to move toward an all Electronic Trial Master File, organizations typically use an Enterprise Content Management system in their efforts to manage clinical trial regulatory documents. The Electronic Trial Master File is recommended to ideally be a document management system containing all the necessary controls. Adoption of electronic document management processes is becoming essential to business productivity, cost savings and shortened BioPharma product development timelines.

Keywords: Electronic Trial Master File, Adoption, BioPharma industry and product development.