Blog
Phase I study death in France prompts EMA updated guidelines on FIH trials
In January of 2016, a Phase I drug trial in France, conducted by the French contract research organization Biotrial, left one volunteer dead and five others hospitalized: four with permanent neurological damage. The drug, named BIA 10-2474, is under development, by...
FDA Guidance on Adaptive Designs released
On July 27th, FDA released final guidance for Adaptive Designs for Medical Device Clinical Studies – a link to the guidance is here. According to Zachary Brennan in his article posted on RAPS, FDA received 151 comments from industry and most were included in the...
Dr. Gretchen Parker, IRB Co-Chair Earns CIP Certification
We are proud to announce that Pearl IRB’s Co-Chair, Gretchen Parker PhD, RAC, CIP has earned the CIP certification. This achievement attests to the unparalleled service, knowledge, and professionalism offered by our IRB. Pearl IRB is an AHRPP accredited, commercial...
Check out ACRP’s new, free training program for Clinical Research Professionals
A press release from The Association of Clinical Research Professionals (ACRP) announces a new educational training program, “Introduction to Clinical Trials”. This presentation was introduced at DIA 2016 in Philadelphia, PA in late June and provides an excellent...
It’s time to take a look at human subjects research regulations
The National Academies of Sciences, Engineering and Medicine released a new report in late June that looks at federally funded research and is now recommending an independent commission be established to take a close look at ethical and legal issues of human subjects...