Late Stage Clinical Trials
Phase II-III Registrational Trials
Designing and executing registrational clinical trials and clinical programs
Develop drugs efficiently with UBC’s Clinical Trial Management for Phase II and Phase III programs. We’ve successfully developed, implemented, and supported many of the industry’s largest and most complex global research programs.
Every product, therapeutic area, and patient population is unique. Yet, our proven experience can help you anticipate the best strategy to collect the evidence and data to support your product needs. Our dedicated team of project managers, clinical research associates, physicians, nurses, statisticians, clinical programmers, and data managers will guide your product with:
- Strategic planning to ensure the data required for the clinical endpoints is met with innovative, yet practical, scientifically rigorous study designs
- Expert guidance to ensure key evidence is collected in alignment with regulatory and reimbursement submission and approval milestones
- Streamlined study start-up processes with respect to document collection, site communication, local and global ethics committees approval, and site activation
- Customized, flexible client reporting
- Local and country-specific understanding of regulatory issues
- Data Management & Biostatistics services
- You’re looking for late stage clinical trial management services you can trust. We’ve built our reputation by demonstrating a consistent track record with innovative solutions. We’re as committed as you are to the successful development and commercialization of your product.
- False starts can happen, and we have the experience to rescue your product and see it through to the end. If your current study services are not bringing in the patients and sites needed, we can help.
Commitment to Success
- Our team’s global experience and understanding of cultural and regulatory requirements helped us complete enrollment for a global Phase III registrational oncology trial three months ahead of schedule and lock the database three and half months ahead of schedule. We also guided parallel regulatory submissions to the FDA and EMA.
- Drawing on our in-depth knowledge of NIS regulatory requirements and regional patterns of care, UBC was able to rapidly start a post authorisation safety study (PASS) for an orphan disease in 106 sites throughout Europe. We completed enrollment one and a half months ahead of schedule.
Contact us to discuss the best strategy for your unique product.