real-world evidence experts
Twenty years in real-world evidence changes how you design studies.
Some evidence needs emerge once studies are underway - payer scrutiny, enrolment bottleneck and evidence gaps that slow decisions later. UBC designs with downstream questions in view from the start.
Observational Research · Post-Marketing Studies · PMR · PASS · HEOR · Modernized Study Design
20+
years of RWE specialization
50+
Indications studied
26
Rare disease programs
5
Primary data partnerships:
DataVant, Komodo, Concert AI, Truveta, Snowflake
100+
observational and post-marketing
studies
Talk through your study with an experienced RWE team
Understanding the problem
‘Real-world evidence’ is everywhere. Real-world experience is rare.
A few years ago, very few CROs were talking about RWE. Now almost all of them are.
The difference is not the language. It’s knowing which questions are likely to surface later – from patients, regulators, payers, clinicians, and medical affairs teams – and designing studies with those downstream decisions in view from the start.
Questions buyers are really trying to answer
- What evidence is most likely to hold up with regulators and payers?
- What level of decentralization is operationally realistic for this population?
- Which data source actually fits the question being asked?
- How quickly can the study move into field without creating problems later?
- What evidence gaps are likely to surface after approval?
Services
One connected evidence team.
Most evidence programs become difficult at the points where teams, timelines, and evidence strategies stop aligning.
A comprehensive study plan shapes reimbursement conversations later. Operational decisions affect participation and retention. Small evidence gaps introduced early often become much harder to solve once timelines tighten.
UBC works across those connections from the beginning, while decisions are still flexible.
Observational research
Evidence that keeps its value beyond approval
Real-world evidence becomes more useful once therapies move into broader clinical practice – across different populations, treatment pathways, and longer timelines.
UBC designs observational studies that help medical affairs, HEOR and payer teams answer questions that rarely stop at efficacy alone. More than 50 indications supported, including 27 rare disease programs.
Capabilities
- Prospective observational studies and registries
- Retrospective cohort studies using secondary data
- Health Economics and Outcomes Research (HEOR)
- Treatment-pattern and line-of-therapy analysis
- Natural history studies
Regulator-grade PMR / PASS
Post-marketing studies built for long-term confidence
PMR and PASS programs require steady operational oversight long after approval milestones are complete.
UBC has spent decades supporting regulator-facing studies across complex therapies, long-term follow-up periods, and evolving reporting requirements – helping sponsors keep long-term programs stable as reporting requirements evolve.
Capabilities
- Protocol design aligned to commitment requirements
- RWD-informed PASS approaches where appropriate
- Site/patient enrolment with velocity to meet commitment deadlines
- Statistical analysis and reporting
- Lifecycle reporting until obligation closes
Modernized study design
Flexible study models built around real participation
Hybrid and decentralized approaches can improve access, reduce burden, and support stronger long-term participation across complex patient populations.
The challenge is making those models work consistently once studies move into the field – across patients, sites, logistics, and long-term follow-up. That operational layer usually determines whether participation and continuity hold up over time.
Capabilities
- Direct-from-patient data capture (ePRO, eCOA, wearables, apps)
- Hybrid site/decentralized models
- Home health support — 60,000+ annual nurse visits
- Privacy-compliant EHR linkage
- FDA / EMA aligned operational models
REAL-WORLD DATA
Better evidence starts with fit for purpose data
The value of real-world data depends on whether it fits the question being asked later – regulatory, clinical, economic, or operational.
Some evidence strategies depend on scale. Others rely on continuity, linkage or visibility across fragmented care pathways. Stronger programs start with a clearer understanding of what the evidence will eventually need to support.
Capabilities
- Claims, EHR, and health system data sources
- Data tokenization and linkage
- Oncology-led RWD expertise, applied across all therapy areas
- Cross-source analytics infrastructure
- Health-system data sources
“Running high-quality clinical trials, registries, studies, is vitally important. But what matters most is how the data from all those programmes translates into access, adoption, and sustained impact.”
Aaron Berger, SVP Evidence Development, UBC
Why experienced RWE teams come to UBC
Built around observational research from the start
UBC was running observational and post-marketing programs long before RWE became standard CRO positioning. That experience shapes how studies are designed, not just how they are described.
Operational models that hold up in the field
Hybrid and decentralized studies work best when participation, retention, and site realities are considered from the beginning – not added later once studies are already moving.
Evidence planned with downstream decisions in mind
Approval is only one milestone. Payer review, long-term safety, adoption, and post-market evidence requests all place different demands on the same data. UBC designs with those pressures in view early.
Deep rare disease experience
Many rare disease programs rely heavily on observational evidence because traditional comparative models are limited or unrealistic. UBC has supported more than 27 rare disease programs across complex patient populations and long-term follow-up environments.
Case Study
Extending cardiovascular trial evidence beyond the study itself
A large European therapeutics company needed a better understanding of how a lipid-lowering therapy was performing before and after a Phase 3b cardiovascular study – without relying entirely on expensive site-based follow-up.
UBC designed a tokenization and linkage strategy connecting EMR, claims, and laboratory data across six years of longitudinal patient history. Of 450 study participants, 89% were successfully tokenized and 85% matched to one or more real-world data sources, giving teams longer-term visibility into patient outcomes, treatment patterns and adverse events beyond site-based follow-up alone.
Case Study
Bringing fragmented rare disease registries into one connected evidence platform
Rare disease evidence is often spread across disconnected registries, academic groups, and regional datasets, making it difficult to build a complete longitudinal view of patients over time.
UBC federated registry environments across the US and Europe into a single harmonized evidence platform spanning more than 1,300 patients, 125 institution-based sites and 12 existing registries. The resulting dataset supported global congress activity, including 19 abstracts, 16 posters, and two manuscripts.
Case Study
Accelerating enrollment in a decentralized SMA follow-up study
With only a small number of specialist centres supporting patients with spinal muscular atrophy across the US, travel burden had become a major barrier to recruitment and long-term participation.
UBC implemented a decentralized enrollment model supported by THREAD technology, remote consent, mobile participation tools, and a nurse-staffed patient coordinating centre acting as PI delegates. More than 30 patients enrolled during the first month, with 50 enrolled within the first year.
FAQS
Early conversations usually focus on the same few 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 (decentralized, 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 modernized 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 organized 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. Modernized study design and late-stage research engagements span Phase II through commercialization, including FDA Post-Marketing Requirements and EMA Post-Authorization Safety Studies. The team also engages later — for label extensions, line extensions, HTA submissions, and ongoing value evidence — when a sponsor inherits a program 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 center 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 operationalizes the studies — choosing the right design (interventional, observational, decentralized, 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.
Talk through your study with an experienced RWE team
Start with the challenge, the question or the concern that’s prompting the conversation. We’ll help you determine whether action is needed, where the priorities sit and what a practical response looks like.
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