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.
A Blueprint to Success: Onboarding a Medical Writer
Onboarding is the process of welcoming new employees into an organization and providing them with the tools, resources, and knowledge to become…
LC-MS/MS Support for Studies with Large Molecules
PRA’s Bioanalytical Laboratories provide LC-MS/MS services to support clients’ studies with biological and small molecules. The information details…
Targeting Patients In A Complex Phase II Rheumatoid Arthritis Study
Targeting Patients In A Complex Phase IIa Rheumatoid Arthritis Study.