Since our inception, we have placed particular emphasis on Phase IIIb-IV trials, because we believe that trials in these phases are now become increasingly important to our clients.
UBC understands that peri and post approval programs have different objectives than traditional studies, thereby requiring customized design and implementation strategies. With clinical development experience spanning two decades, we have designed and managed peri-approval programs of all sizes and complexities – across all therapeutic areas – including:
- Safety surveillance studies
- Regulatory mandated studies
- Large streamlined studies (LSSs)
- Actual use studies
- Randomized clinical trials
- SAMM and PASS studies
- Expanded access programs
- Treatment IND
- Compassionate use
- Observational epidemiologic studies
- Registries
- Natural history of disease
- Patient and practitioner compliance
- Actual use patterns of care
- Demonstration programs
- Case control studies
For over 10 years, UBC has designed, implemented and analyzed product and disease registries and pregnancy exposure registries to meet regulatory requirements and address commercial objectives. And for more than 25 years, our industry-leading experts have been involved in both governmental and industry studies.
As a full-service registries company, UBC has broad experience in epidemiologic consultation, protocol writing, site identification, site enrollment, site management, patient recruitment, patient retention, patient follow-up, direct-to-patient interviews, data management, and Risk MAPs.
UBC's services include:
- Product and disease registries
- Pregnancy exposure registries
- Patient Registry Coordinating Center
- Study design and protocol development
- Site feasibility and investigator selection
- Project management
- Patient recruitment and retention
- Study monitoring
- Study Management & Sales Training
- Biostatistics and data management
- Regulatory consultation