Paperless clinical trials: Myth or reality?
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.
Department of Pharmacology, Dhanalakshmi Srinivasan Medical College and Hospital, Siruvachur, Perambalur, Tamil Nadu, India.
Sandeep K
SK
Gupta
D002986:Clinical Trials as Topic / Q000379:methods*; D003625:Data Collection / Q000379:methods / Q000639:trends; D017277:Drug Approval; D057286:Electronic Health Records / Q000639:trends*; D006801:Humans; D016247:Information Storage and Retrieval / Q000379:methods* / Q000639:trends; D008490:Medical Informatics / Q000639:trends
Clinical trial; clinical trial management systems; electronic data capture; electronic health records