Since our inception, we have placed particular emphasis on the post-approval area, specializing in Phase IIIb-IV trials.
We understand that large streamlined studies and registries are increasingly important tools for post-approval safety surveillance, risk assessment and risk management. So we have staffed UBC with leading scientists in epidemiologic consultation, protocol writing, data management, site identification and enrollment, REMS, and patient recruitment and retention.
Because patient safety is at the very core of what we do, we provide unmatched expertise to help our clients meet regulatory requirements and manage risk for their drugs.
We are highly skilled in the design and implementation of health outcome research studies to evaluate the effectiveness of biopharmaceuticals and other health care interventions.
Finally, we are committed to a holistic, strategic approach to all facets of post-approval work – from helping our clients gain the best position for market access to preparing detailed plans for ensuring coverage and payment by third-party payers to hiring only highly trained project managers.