Author: rupam debnath

Benefits of Risk-Based Monitoring in Clinical Trials

Posted on by rupam debnath

Monitoring of clinical trials is a critical activity required to be carried out during the entire lifecycle of the trial to validate that it is conducted as per the approved protocol. Monitoring should also uphold the GCP requirements to ensure the integrity of trial data, safety, and rights of subjects. The following are the major Read more about Benefits of Risk-Based Monitoring in Clinical Trials[…]

5 Ways to Avoid FDA Warning Letters through Automated CTMS Solution

Posted on by rupam debnath

The violations of regulatory compliance may lead to the issue of FDA Warning Letters. Over the recent years, most of these warning letters are due to non-compliance or negligence in the audit trail documentation practices. Most frequent reasons to Issue FDA warning letters Document control best practices to help companies avoid FDA warning letters 1. Establish Document Control Read more about 5 Ways to Avoid FDA Warning Letters through Automated CTMS Solution[…]