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.
We’re committed to meaningfully integrating sustainability considerations into our business practices and culture. The work we do has a global…
Global Capabilities in Central Nervous System
PRA Health Sciences’ Early Development Services (EDS) group has a long-standing record of early clinical development work in various neuroscience and…
Targeting Patients In A Complex Phase II Rheumatoid Arthritis Study
Targeting Patients In A Complex Phase IIa Rheumatoid Arthritis Study.