Late-Stage Research
Multidisciplinary Expertise Spanning Late-Stage Development
We deliver a reliable, rigorous pathway to regulatory approval and optimized post-approval outcomes.
Late-Stage Research Integrations: Full-Service Offerings
Generating evidence across the product lifecycle.
New treatments for patients confront a myriad of challenges on the journey from Phase II through commercialization. UBC is a purpose-driven organization dedicated to generating evidence that addresses important questions on the safety and effectiveness of treatments along the late-stage development continuum. We partner with biopharma to bring treatments to market by:
- Developing the evidence road map strategy
- Designing modernized, technologically progressive studies
- Executing studies in a full-service, high quality, and rapid fashion
Purpose of the Research
- Registration & Marketing Authorization
- Post Marketing Requirements (FDA PMR / EMA PASS)
- Line Extension
- Label Expansion
- Publication Strategy
- Expanded Access Prior to Approval
- Market Access to Support HTA Decision Making
Studies We Design and Execute
- Interventional Clinical Trials
- Prospective Observational Disease & Exposure Studies
- Decentralized / Virtual / Direct-to-Patient Studies
- Interventional & Observational RWE Studies
- Chart Review / Natural History Studies
- Pragmatic Trials
- Comparative Effectiveness Studies
- External Control Arms
Services We Provide
With decades of experience, our team offers unparalleled expertise and efficient strategies for facilitating the full scope of late-stage research, from mandatory post-marketing requirements to discretionary observational studies. We help our partners navigate the journey to regulatory approval and optimized post-approval outcomes through a variety of services, including:
Study oversight and execution
- Project Management
- Site Management
- Clinical & Evidence Operations
- Medical Monitoring
- Decentralized Research
Specialized technical capabilities
- Protocol Writing
- Epidemiology Consulting
- Biostatistics
- Medical Writing
- Analytics & Informatics
Patient relationship support
- Patient Recruitment & Engagement
- Home Nursing
- Central Site / Patient Coordinating Center
Advanced data and technology solutions
- Data Management
- Electronic Data Capture
- Technology Platform (ePRO, eCOA, Telehealth)
- Secondary Data Acquisition (EMR, Lab, Claims, Genomic)
Learn More About UBC's Late-Stage Research
Interested in learning more about how UBC’s late-stage research services can help you unite evidence and access to inform complex decisions?
