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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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Formato: | Online Artículo Texto |
Lenguaje: | English |
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Medknow Publications & Media Pvt Ltd
2015
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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. |
collection | PubMed |
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. |
format | Online Article Text |
id | pubmed-4527052 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2015 |
publisher | Medknow Publications & Media Pvt Ltd |
record_format | MEDLINE/PubMed |
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 |
work_keys_str_mv | AT guptasandeepk paperlessclinicaltrialsmythorreality |