The new FDA draft guidance issued last during the second week of November demonstrates that FDA does not want institutional review boards (IRBs) to lose their critical role in the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...
Ken Getz, assistant professor at Tufts Center for the Study of Drug Development (CSDD), reports that oftentimes procedures performed in the last drug development stages are in order to find “supplementary, secondary, tertiary, and exploratory endpoints.”...
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.
On October 14, the 7th Annual Site Solutions Summit announced the formation of a new association focusing on the needs and challenges of the research site. President of The Society for Clinical Research Sites (SCRS), Christine Pierre is aiming to “provide...
The Coalition For Accelerating Standards and Therapies (CFAST) was introduced at the CDISC International Interchange in Baltimore October 22-26. By congregating experts from each industry, data standards are expected to be maintained and developed. The coalition...
