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.
Pharmacokinetic Characteristics of Intranasal Administration of Oxycodone ARIR
Abuse of prescription opioids continues to be a serious public health concern, with as many as 12.5 million individuals aged 12 or older reporting…
PRA Successfully Delivers A Complex Phase I Psoriasis Study
Exceptional Support and Innovative Strategies Combat Study Challenges.
PRA’s Vaccine Solutions group understands the unique challenges and characteristics of vaccine development. Right from the start, our experts will…