Evidence Development
Expect more from your evidence
We provide expert-driven real-world evidence tailored to specialty patient populations to uncover more valuable insights, maximize commercial positioning and optimize regulatory approval for the long-term value of your therapy.
Generate Fit-for-Purpose Real-World Evidence to Support the Product Life Cycle
UBC’s expert, multi-disciplinary, real-world evidence (RWE) team supports biopharma in developing valuable evidence on the safety, effectiveness, and value of treatments. We do this through expert strategic consulting, research design, and operational delivery of modernized studies that leverage best-in-class evidence development technology solutions for data acquisition. With an integrated evidence generation strategy, we provide roadmaps from study design through late-stage research.
An Experienced Real-World Evidence Partner
Decades of thought partnership and operational delivery of RWE programs.
UBC is an industry-recognized leader with over 20 years of world-class observational research and RWE experience. We develop end-to-end integrated evidence generation strategies, identify fit-for-purpose data sources, operationalize full-service study solutions, and provide regulatory-grade data analytics for pharmaceutical development. Our team is unmatched, with decades of relevant epidemiology, medical, scientific, and data science expertise. We are purpose-built for RWE and post-marketing research.
The UBC Difference in Evidence Development
A complete offering of RWE solutions to meet your needs at any stage of the product lifecycle.
We are a partner you can trust to build an RWE program with intelligent foresight and patient-centric results. Our comprehensive approach addresses key stakeholder needs by developing integrated evidence generation strategies to provide a road map going forward; maximizing the value of research with modernized study design; and resolving important questions along the late-stage development continuum.
Evidence Generation Consulting
- Integrated Evidence Generation Planning (IEGP) & Roadmap Development
- Value Story Creation
- Epidemiology Services
- HEOR & HTA Solutions
- AI-Enabled Evidence-Generation Solutions
Modernized Study Design & Execution
- Decentralized and Hybrid Studies
- Patient & Site Recruitment
- Real-World Data Acquisition & Technology
Late-Stage 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
Real-World Evidence and HEOR
- AI-assisted Systematic and Targeted Literature Review
- Living Reviews
- Complex Statistical Analysis
- Strategic Consulting
- Health Economic Modeling
- Medical Writing and Publications
Frequently Asked Questions
What does UBC's evidence development capability cover?
Three integrated sub-capabilities: Integrated Evidence Generation Strategy (the consulting layer that defines what evidence to generate and why), Modernized Study Design & Execution (decentralised, hybrid, and direct-to-patient designs leveraging real-world data), and Late-Stage Research (full-service operational delivery of observational, post-marketing, and hybrid studies). Most sponsors engage with one or two; the value of having them under one roof is continuity.
Is UBC a CRO, an RWE specialist, or a consultancy?
All three, in the parts of evidence development where each matters. UBC is purpose-built for RWE and post-marketing research — not a traditional CRO bolting on observational capability. The consulting layer functions as a strategy advisor; the modernised study design and late-stage research layers function as operational delivery. The combination is what most large CROs and pure-play RWE specialists can’t offer at the same depth.
How does UBC's evidence development differ from a traditional CRO's?
Large CROs are organised around interventional Phase III protocols, where their operational scale is genuinely advantageous. UBC’s model is built for the late-stage and post-marketing work where data is messier — secondary sources, observational designs, hybrid models. The team is led by epidemiologists, data scientists, and HEOR experts, not generalist clinical operations leaders, which changes how trade-offs get made when the data doesn’t behave like a Phase III dataset.
When in the product lifecycle does UBC's evidence work typically start?
The strategy work often starts mid-Phase II, ahead of late-stage protocol decisions. Modernised study design and late-stage research engagements span Phase II through commercialisation, including FDA Post-Marketing Requirements and EMA Post-Authorisation Safety Studies. The team also engages later — for label extensions, line extensions, HTA submissions, and ongoing value evidence — when a sponsor inherits a programme or needs to refresh evidence post-launch.
What disciplines sit inside UBC's evidence development team?
Epidemiology, biostatistics, HEOR, medical writing, clinical operations, data science, real-world data acquisition, regulatory affairs, patient recruitment and engagement, and analytics and informatics — with home nursing and a central site / patient coordinating centre for operational reach. The combination is built for evidence questions that span regulator, payer, clinician, and patient simultaneously.
Can UBC support both regulatory and commercial evidence needs?
Yes — and they’re treated as a single planning problem, not two. Regulatory evidence (PMR/PASS, label extensions) and commercial evidence (HTA, payer value stories, real-world value demonstration) typically draw on overlapping data and overlapping stakeholders, so designing them in isolation creates rework. UBC’s integrated evidence strategy work is specifically about resolving this upstream.
How do the three EDS sub-capabilities work together?
Integrated Evidence Generation Strategy defines the questions and roadmap. Modernized Study Design & Execution operationalises the studies — choosing the right design (interventional, observational, decentralised, hybrid) and the right data sources for each question. Late-Stage Research delivers the studies and the operational layer underneath. Sponsors can engage any one of the three independently, but the value of doing them together is that decisions made upstream don’t have to be retro-fitted later.
Learn More About UBC's Evidence Development Strategic Approach
Interested in learning more about how UBC’s evidence development strategic approach can help you unite evidence and access to inform complex decisions?
