In December, FDA issued a draft guidance, Master Protocols for Drug and Biological Product Development. This guidance is currently in the public comment period; comments
The clinical trial industry is constantly evolving, with electronic Trial Master Files (eTMF) becoming increasingly popular among sponsors and CROs. By reducing the need for
Electronic Data Capture (EDC) has become an essential part of clinical trials, providing a more efficient way to collect, manage and analyze data. Mobile EDC
TMF completeness findings are the most commonly reported inspection findings. For example, in them most recently published MHRA GCP inspection report , there were twice
Managing eTMF (electronic trial master file) is a challenge. However, some organizations impose burdens upon themselves by following practices that aren’t consistent with Health Authority guidance. In
Read the White Paper: Clinical Analytics: The Journey from Problem Identification to Solution Encouraged by Health Authorities, Life Sciences organizations have moved towards risk-based approaches
Summary Sponsors receiving TMFs from CRO partners at the end of a study often experience quality issues when attempting to archive the TMFs. This post
On February 12, 2021, The UK Medicines & Healthcare Products Regulatory Agency (MHRA) published their annual GCP Inspections Metrics Report. This report covered the period
The MHRA Inspectorate Blog recently posted a post [i] discussing Corrective and Preventive Actions, the importance of root cause analysis, and what triggers inspectors to
FDA has issued a final guidance document on Civil Money Penalties Relating to the ClinicalTrials.gov Data Bank. This draft guidance was first issued in 2018
I have recently published a peer-reviewed paper called “Optimize Your eTMF Strategy”, that you can read or download on the Journal for Clinical Studies (Volume
Electronic Data Capture (EDC) solutions have been used for a couple of decades now with more systems available today than one can count. From the
On July 17th, the FDA and Duke Margolis Center for Health Policy sponsored a workshop entitled “Improving the Implementation of Risk-Based Monitoring Approaches of Clinical
Managing essential documentation for clinical trials has become quite complex in today’s clinical research environment. Study sponsors are required to implement a quality system to
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