Clinical DevelopmentObtain regulatory approval through innovative research methods that maximize ROI
UBC’s experience in strategic clinical development and execution of studies spans four decades, across most therapeutic areas, and around the world. UBC’s Clinical Development teams collaborate with manufacturer sponsors to help ensure conclusive study results and meet global regulatory submissions requirements. Our expertise in the design, conduct, and analysis of full-service clinical development programs makes certain that safety and efficacy evidence needs are satisfied for regulatory review.
Clinical research is undergoing tremendous change. As molecules become more tailored to individual patients, the high-quality data needed to satisfy regulators has become increasingly complex. This means manufacturers need partners that understand patient and population dynamics, global treatment and practice patterns, and challenges in settings of care. UBC has depth and breadth of expertise in providing:
- Phase II-III Registrational Trials
- Long-Term Safety Programs
- Expanded Access Programs
- Global Site Management
- Risk-Based Monitoring
- Patient and Physician Recruitment & Retention
- Data Management & Biostatistics
- Regulatory Writing Services
- Quality Assurance
- Innovative Technology Platforms
- Clinical Trial Support – Home Health Nurses
UBC understands that companies make significant investments in research to support regulatory review and approval of their products. UBC also appreciates the need to plan for commercial success early in the development lifecycle. Manufacturers need a partner who has the therapeutic expertise to effectively address the unique needs of each product, patient, and physician. UBC has extensive experience designing and implementing clinical programs across many therapeutic categories, including:
- Endocrine & Metabolic
- Infectious diseases
Commitment to Success
- Last year alone, UBC managed global studies across 32 countries with nearly 5,000 central and on-site monitoring visits.
- Our Phase II –IV and registries include more than 100,000 sites 1.2 million patients.
Contact us to put our clinical development team to work for your product.