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Paperless clinical trials: Myth or reality?
Author(s) -
Sandeep Kumar Gupta
Publication year - 2015
Publication title -
indian journal of pharmacology/the indian journal of pharmacology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.286
H-Index - 59
eISSN - 1998-3751
pISSN - 0253-7613
DOI - 10.4103/0253-7613.161247
Subject(s) - clinical trial , process (computing) , adaptation (eye) , process management , risk analysis (engineering) , business , medicine , computer science , knowledge management , psychology , pathology , neuroscience , operating system
There is an urgent need to expedite the time-to-market for new drugs and to make the approval process simpler. But clinical trials are a complex process and the increased complexity leads to decreased efficiency. Hence, pharmaceutical organizations want to move toward a more technology-driven clinical trial process for recording, analyzing, reporting, archiving, etc., In recent times, the progress has certainly been made in developing paperless systems that improve data capture and management. The adaptation of paperless processes may require major changes to existing procedures. But this is in the best interests of these organizations to remain competitive because a paperless clinical trial would lead to a consistent and streamlined framework. Moreover, all major regulatory authorities also advocate adoption of paperless trial. But challenges still remain toward implementation of paperless clinical trial process.

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