Oct 15, 2019 | Clinical Biometrics
In Clinical trials, objectives, outcomes, evaluation, sponsors, efficacy, endpoints, analysis, etc., – all these matters. But you know what, SAFETY takes the front seat. Webisode 1 of Bots automate Clinical Data Management Safety events reporting and monitoring is...
Sep 13, 2019 | Clinical Biometrics
If you have searched for emerging trends in technology, you couldn’t have missed Blockchain. While some of you might have known this technology as the one that drives bitcoins, I request you to take a step back, as it does a lot more than just that. In this article I...
Aug 17, 2019 | Clinical Biometrics
FDA requirements state that an Integrated Summary of Safety (ISS) and Integrated Summary of Effectiveness (ISE) should be included in the Common Technical Document (CTD) for a regulatory submission.The word ‘summaries’, in this context, can be misleading as they are...
Aug 17, 2019 | Clinical Biometrics
Clinical Trials (CT) remain to be one of the most expensive and critical stage in life science value chain and data collected from CT is critical. Clinical data management has grown steadily in the past decade from paper-based system to electronic system. This change...
