Phase IV – RWE
Real-world evidence built to hold up, not just report
+250
RWE and Phase IV studies completed
+100,000
Patients across RWE and Phase IV studies
+7,000
Sites in 19 countries
What Phase IV & RWE delivery includes
Phase IV & RWE
- 50% of operations staff bring direct RWE experience
- Prospective observational studies
- Retrospective chart reviews
- Registries, drug or disease
- Phase IV and pragmatic trials
- Cross-sectional studies: patient-reported outcomes, compliance, satisfaction
- Database studies: new-user designs, self-controlled case series and related methodologies
Built on four capability pillars
A digital RWE platform
We activate high-performing sites across 40 countries to meet rigorous recruitment targets. You secure global reach while keeping your trial a top priority, backed by dedicated teams that stay.
Real-world data access
Integrated EDC and eSources: eConsent, ePRO and eDiary, remote visits, and wearable and biosensor data, so the study runs on current technology rather than paper-era workarounds.
Analytics built for real-world bias
Confounding adjustment methods including propensity score matching and IPTW, predictive analytics through machine learning, unstructured data processing via NLP, and OMOP-OHDSI expertise for data standardization.
Life science strategy
The TFS RWE Algorithm guides study design, protocol optimization, endpoint and sample size planning, and bias and confounding management from the start, rather than correcting for it after data collection begins.
Why sponsors choose TFS for Phase IV & RWE
Teams that stay
88% of our teams stay for the whole study, 8 percentage points above the industry average. Late-phase and RWE programs often run for years: continuity matters more here than almost anywhere else in clinical development.
Therapeutic depth
Scientific, epidemiological, medical, statistical, technological and operational expertise in one cross-functional team, not a generalist RWE unit applied across every indication.
Data relationships already in place
Access to 300+ healthcare data sources across the EU and North America, more than 60 transnational databases, and over 20 ongoing collaborations with data owners. You’re not waiting on TFS to negotiate access before your study can start.
Evidence built for scrutiny, not just collection
Confounding adjustment, predictive analytics and OMOP-OHDSI data standardization are built into study design from day one, so the evidence holds up when a regulator or payer examines it, not just when it’s first collected.
Featured Case Study
When a non-interventional breast cancer study needed its interim analysis 10 days ahead of a tight plan, the TFS HealthScience oncology team did not add people or push back on the ask. They changed how the team worked.
Phase IV & RWE FAQs.
What types of Phase IV and real-world evidence studies does TFS support?
What real-world data sources does TFS have access to?
How does TFS ensure regulatory and scientific rigor in RWE studies?
Can TFS support hybrid or decentralized elements in late-phase studies?
Global presence designed for local agility
International scale, deep local roots
We have built our structure by integrating established clinical teams across key markets, rather than handing off trials to unknown third parties. Operating directly on the ground allows us to navigate local regulations, streamline ethics approvals and keep recruitment on track.
