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)
Frequently Asked Questions
What does late-stage research cover at UBC?
Late-stage research spans Phase II through commercialisation, including registration and marketing authorisation support, FDA Post-Marketing Requirements (PMR) and EMA Post-Authorisation Safety Studies (PASS), label expansion, line extension, publication strategy, expanded access ahead of approval, and HTA support for market access. The work is intentionally not boxed into one study type — the design follows the question.
What kinds of studies does UBC actually run?
The team designs and executes interventional clinical trials, prospective observational disease and exposure studies, decentralised and direct-to-patient studies, hybrid interventional/observational RWE studies, chart review and natural history studies, pragmatic trials, comparative effectiveness studies, and external control arms. Sponsors often arrive thinking they need one of these; part of the early work is confirming which design will actually answer the regulatory or commercial question on the table.
Why work with UBC for post-marketing requirements rather than a large CRO?
Post-marketing studies use secondary data, mixed sites, and uncontrolled populations — they are messier by design than Phase III. Large CROs are organised around interventional protocols, where their operational muscle is genuinely advantageous. UBC’s late-stage team is built specifically for observational and hybrid work, with epidemiologists, biostatisticians, and site-recruitment specialists who treat real-world data as the starting point rather than the awkward case.
What capabilities does UBC bring beyond running the study?
Study oversight (project management, site management, medical monitoring, decentralised research delivery), specialised technical capability (protocol writing, epidemiology consulting, biostatistics, medical writing, analytics and informatics), patient relationship support (recruitment and engagement, home nursing, central site and patient coordinating centres), and the data and technology layer (data management, EDC, ePRO/eCOA/telehealth platforms, and secondary data acquisition across EMR, lab, claims and genomic sources). Most sponsors pick the components that fill gaps in their internal model rather than taking everything.
How does UBC approach rare disease and small populations?
Rare disease late-stage research depends on patient-finding, advocacy engagement, and tolerant study designs that can handle small, geographically dispersed populations. UBC combines investigator networks, advocacy relationships, home nursing reach, and direct-to-patient recruitment to identify and engage patients who would not typically participate in traditional site-based trials. Where appropriate, secondary data sources fill the periods between visits to reduce burden on patients and sites.
What does the evidence road map look like in practice?
Early in engagement, the team works with sponsors to define what must be demonstrated — and to whom — across regulators, payers, and clinicians, then designs the evidence plan to address those questions in parallel rather than in sequence. The road map covers which data sources will support each question, where modernised study designs reduce duplication, and when each output (publications, HTA submissions, label extensions) needs to land. It is a working document, not a deliverable.
Can UBC support the safety story alongside the value story?
Yes — and the team treats this as a single workstream rather than two parallel ones. Late-stage research sits close to UBC’s pharmacovigilance and Health Economics & Outcomes Research (HEOR) capabilities, so safety signal detection, benefit-risk narratives, value dossiers, and budget impact models can be developed against the same evidence rather than separately curated views of it.
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?
