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...
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...
Reading an article by Ed Miseta, Clinical Leader, brought to mind the importance of the balance of patient’s needs and scientific advancement. Miseta’s article shared comments from leaders in Pharma where empowered patients and their community voice is recognized and...
Melissa Fassbender of Outsourcing-Pharma.com recently published an article about The International Committee of Medical Journal Editors (ICMJE) proposing authors share clinical trial data as a prerequisite to publish. The ICMJE brings up a very good point that...
Insight Pharma Reports interviewed 100 clinical trials professionals asking questions on issues of patient enrollment, how mobile technology is working, patient engagement and clinical trial software. According to the survey results, clinical trials staff have...