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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 clinic...

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Detalles Bibliográficos
Autor principal: Gupta, Sandeep K.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Medknow Publications & Media Pvt Ltd 2015
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4527052/
https://www.ncbi.nlm.nih.gov/pubmed/26288464
http://dx.doi.org/10.4103/0253-7613.161247
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author Gupta, Sandeep K.
author_facet Gupta, Sandeep K.
author_sort Gupta, Sandeep K.
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description 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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spelling pubmed-45270522015-08-18 Paperless clinical trials: Myth or reality? Gupta, Sandeep K. Indian J Pharmacol Review Article 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. Medknow Publications & Media Pvt Ltd 2015 /pmc/articles/PMC4527052/ /pubmed/26288464 http://dx.doi.org/10.4103/0253-7613.161247 Text en Copyright: © Indian Journal of Pharmacology http://creativecommons.org/licenses/by-nc-sa/3.0 This is an open-access article distributed under the terms of the Creative Commons Attribution-Noncommercial-Share Alike 3.0 Unported, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
spellingShingle Review Article
Gupta, Sandeep K.
Paperless clinical trials: Myth or reality?
title Paperless clinical trials: Myth or reality?
title_full Paperless clinical trials: Myth or reality?
title_fullStr Paperless clinical trials: Myth or reality?
title_full_unstemmed Paperless clinical trials: Myth or reality?
title_short Paperless clinical trials: Myth or reality?
title_sort paperless clinical trials: myth or reality?
topic Review Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4527052/
https://www.ncbi.nlm.nih.gov/pubmed/26288464
http://dx.doi.org/10.4103/0253-7613.161247
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