In July 2017, the European Medicines Agency (EMA) published its revised guidance on first-in-human (FIH) and early clinical trials. The revision provided detailed guidance to identify risks to trial participants arising from uncertainty associated with the medicinal product tested and to mitigate these risks in trial design and conduct. Clinical study protocols address the provisions of the revised guidelines, complying with applicable guidance for protecting the safety and wellbeing of participants and producing strong scientific outcomes. The protocol also provides latitude for justified alternative study design approaches.
PRA’s Vaccine Solutions group understands the unique challenges and characteristics of vaccine development. Right from the start, our experts will…
Retrospective Analysis of the Effects of Protocol Design on Completion Rates in Phase 1 Studies in Subjects with Stable Schizophrenia
Subject attrition from randomized Schizophrenia trials is a significant problem and has been found in meta-analysis to be as high as 76% (Robinowitz…
PRA Successfully Delivers A Complex Phase I Psoriasis Study
Exceptional Support and Innovative Strategies Combat Study Challenges.