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Ramification of COVID-19 on Clinical Trials with Special Focus on Data Management and Possible Mitigation Strategies 1

Clinical Biostatistics and Biometrics

Ramification of COVID-19 on Clinical Trials with Special Focus on Data Management and Possible Mitigation Strategies

Tanmay Dinesh Gawde

 

1303, Sai Raj Heights, Sector-20, Plot no. 68, Roadpali, Navi Mumbai-410218

 

*Corresponding author: Tanmay Dinesh Gawde, 1303, Sai Raj Heights, Sector-20, Plot no. 68, Roadpali, Navi Mumbai-410218, E-mail: tanmaygawde311@gmail.com

 

Citation: Tanmay Dinesh Gawde, (2020) Ramification of COVID-19 on Clinical Trials with Special Focus on Data Management and Possible Mitigation Strategies. Clin Biostat Biometr. 1(1); 1-5

 

Copyright: © 2020, Tanmay DG, This is an open-access article distributed under the terms of the Creative Commons Attribution 4.0 International License, which permits unrestricted use, distribution and reproduction in any medium, provided the original author and source are credited

 

ABSTRACT

 

As we know how the current COVID-19 Pandemic situation is potentially affecting all over the globe. Like many other fields it influencing the clinical research areas as well. As we know the data generated from the clinical trials plays pivotal role in drug development process. The main source of information is investigator sites; however, due to current situation it is a strenuous task to collect and report data from investigator sites. It has increased potential risks over achieving primary or secondary objectives of the clinical trials. Considering these challenges, there is need to check for the alternatives, check for the feasibility of new technologies, new methods of data collections, think over the mitigation plans and look for the innovations. This is now become a new vision for many companies, institutes. This article will touch on few points on how clinical trials and data management system are impacted due to wake of COVID-19. We will try to throw some light on few mitigation strategies as well.

 

KEYWORDS: Clinical Research, Clinical Data Management, COVID-19, Electronic Data Capture

 

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