CDISC Checks, a private detective

CDISC Checks, a private detective

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

Automated Safety Reporting System

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...