The European Medicines Agency (EMA) released a report on Tuesday that analyzed over 100 applications submitted for medicines in the fields of psychiatry or neurology between 1995 and 2014. In the report, EMA concludes that various challenges can arise in the...
Clinical research, when done correctly, provides a plethora of benefits to the researchers involved in the process as well as patients enrolled in the trials. Setting up a successful clinical trial process was the topic of a recent breakout session led by Daniel R....
Two weeks ago, the US Food and Drug Administration (FDA) announced the withdrawal of a proposed rule from 2001. The rule would have required the public disclosure of summaries of safety and effectiveness data from pre-market clinical trials of gene therapies and...
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...
Gretchen Parker, PhD, RAC, CIP, and Pearl IRB Co-Chair, has completed another article published by Cureus. The title of the article is “A Framework for Navigating Institutional Review Board (IRB) Oversight in the Complicated Zone of Research”. The article provides...
Reminder to register for the October 3rd ACRP Circle City Chapter 16th annual fall symposium at the Ritz Charles in Carmel, IN. Pearl Pathways’ CEO and President Diana Caldwell will moderate a panel discussion of The Future of Research in Indiana. There will be...