Jul 21, 2020 | Clinical Biometrics, Lab Informatics
On the other day, I was speaking to my friend who works in process development for a chip manufacturer in New Mexico. Being a jolly person in general, hearing him speak this time around was miserable. He described how his organization was re-purposing its...
Jun 10, 2020 | Clinical Biometrics
COVID-19 pandemic has left sponsors with many questions and decisions to take regarding the continuity or adaptation of the ongoing clinical trials. Sponsor: Yes, I do have a lot of questions. Zifo: Have you gotten around to reading the “FDA Guidance on Conduct of...
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,...
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...
