Registries And Observational Studies
UBC understands the challenges surrounding registries and other real-world data studies. Our epidemiological approach to registries and other non-interventional studies focuses on collecting relevant data to understand the natural history of the diseases for which treatments are being developed, and the real-world use of medicinal products in the post-marketing period, either as an ad hoc study, in electronic medical records, or by leveraging existing databases and registries.
Increasingly, regulators, payers, providers and patients require real-world safety, effectiveness, and other outcome data to support approval, reimbursement and treatment decisions. We design and implement studies to meet these needs while at the same time minimizing burden to investigators and patients. Our work spans all therapeutic areas, with a particular focus on rare disease and orphan indications, and on advanced therapy medicinal products (ATMP) such as biologics, cellular immunotherapy, genetically modified T-cell therapies and vector-based gene therapy.
Services: Designing & Implementing Protocols for:
- Product and disease registries
- Retrospective chart reviews
- Retrospective database studies
- Customizable database feasibility studies for US and European protocols
- Pregnancy exposure registries
- Natural history studies
- Drug utilization studies
- Post-marketing requirement studies, including PASS
- Prospective observational cohort studies
- Large simple studies and pragmatic studies
- Time and motion studies