KMR Group recently concluded an analysis spanning ten years, from 2005 to 2015, that evaluated cycle time performance for more than 17,000 interventional trials. The analysis investigates clinical trial differences by molecule type and shows an increase in both length...
The new FDA draft guidance issued last during the second week of November demonstrates that FDA does not want institutional review boards (IRBs) to lose their critical role in the clinical research process. The new guidance, issued in November 2012 entitled “IRB...
Outsourcing-Pharma is heading to Hamberg for Partnerships in Clinical Trials Europe 2012. Stay up to date with on their latest advances in the clinical research industry here.
Single IRB – A Guide to the Common Rule sIRB Mandate
The sIRB requirement is active. Is your study affected?