Advancing Peri- and Post-Approval Research

Evidera’s interventional study team has extensive experience in designing global, regional and single country studies in the peri- and post-approval space, including traditional IIIb/IV studies as well as Extended Access/Open Label Extension, Expanded Access/Compassionate Use, Lactation/Placental Transfer, and Regulatory Post Marketing Commitment Surveillance Studies. This research generates impactful medical data through structured studies that build a larger body of evidence around a product or specific patient population to better inform appropriate clinical practice, enable optimal commercialization and market access, and address specific post-approval health authority requirements. All of our studies are conducted following Good Clinical Practice (GCP) and research principles, but do not require the same level of monitoring or lab collection since the research often follows the standard of care.