Global Data Integrity Guidelines

Global Data Integrity Guidelines

Complying with different regulatory agency guidelines for data integrity can be tricky, given the nuances of each agency in terms of its focus and expectations. Let’s take a quick look at where the three major global regulatory agencies stand with respect to their...
Data Integrity Remediation

Data Integrity Remediation

When we talk about Data Integrity, are we focusing enough on the R&D space? Zifo conducted a webinar to discuss how one can address Data Integrity gaps in R&D labs in a cost-effective manner. We had members of the Quality and Compliance functions of leading...
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...
Understanding the MRA

Understanding the MRA

As a compliance consultant, I have always wondered why the same facility or site is inspected by multiple agencies even though the audit reports from the first inspection has demonstrated compliance. After years of contemplation, a big step was achieved last month...