CDISC Checks, a private detective

Feb 13, 2020 | Clinical Biometrics

Introduction Clinical data should be in standardized format in accordance with submission to FDA. Data Integrity is the key element for review to regulatory bodies. And, CDISC has paved n ways for validating clinical data to ensure the submission quality. Regardless,...

Automated Safety Reporting System

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...

Breaking down the Blocks: Explaining Blockchain in Clinical Environment

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...

Differentiating the Integration Puzzle – How to master your ISS/ISE submissions to FDA

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...

Bots Automate Clinical Data Management

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...