Real World Evidence

(Non-Interventional Studies/Phase IV)

Your global partner for quality evidence and reliable outcomes

Every research question is unique, and so is every study. TFS HealthScience works with you to select the best methodologies for your non-interventional and late phase studies. We access a variety of data sources, tools, technologies, and sites for your unique project to extract the best outcome.

Global Real World Evidence: introducing

TFS ReAL combines a strong scientific focus with local expertise and global capabilities. We have a cross-functional expert team including scientific, epidemiological, medical, statistical, technological, and operational professionals.

Our capabilities include four main pillars:

RWD Sources

e-Digital

Analytics

Life Science

RWD Sources

Enabling RWD access:

  • Best Public/Private RWD for:
    – Feasibility / I/E criteria    – Patient recruitment

    – Historical cohorts    – Observational studies

  • Local expertise (Nordic registries, NIS approval tips)

e-Digital

Digital RWE platform:

  • Integrated EDC – eSources:
    – eConsent– ePRO/eDiary
    – eRetention– e(remote) Visits

    – eHealth: Wearables/biosensors, Smartphone data

Analytics

Best-in-class evidence:

  • Confounding adjustment (PSM, IPTW)
  • Predictive analytics (multivariate,
    machine learning, AI)
  • Unstructured data processing (NLP)
  • OMOP-OHDSI expertise

Life Science

RWE intelligence:

  • Study design: TFS-RWE Algorithm
  • Protocol optimization: endpoints, sample
    size, bias & confounding
  • Increased ROI: commercial value
  • Expertise biomarkers/genomics
  • Increased impact factor

TFS RWE at a glance

50
%
Operations staff with RWE experience
250
Studies
100,000
Patients in RWE and Phase IV Studies
7,000
Sites
19
Countries where studies have been performed
25
+
Clients
300
+
Healthcare data sources in the EU and NA
60
+
Transnational databases
20
+
Ongoing collaborations with data owners

Transform Real-World Data into Real-Time Insight

Late-phase and real-world studies rely on accurate data, long-term visibility, and efficient monitoring. TFS empowers your Phase IV and RWE programs with smart, scalable technology that simplifies data integration, drives compliance, and accelerates evidence generation—no matter the study scope or geography.

Advancing Clinical Development Through Technology

Unlocking the power of data from clinical practice

Late phase studies are essential to confirm the safety and effectiveness of drugs in clinical practice. They also play a vital role in addressing important research questions like disease epidemiology, patient-reported outcomes, or prognostic factors of response.

With more than 20 years of experience designing and running non-interventional studies (NIS) and pragmatic Phase IV trials across a broad range of indications at nearly 7,000 sites worldwide, we strategically target the best sites and right data sources to assess real-world outcomes. What’s more, we have worked with tens of thousands of patients and performed hundreds of studies including all types of designs and challenges (biases, confounding, missingness) – you get all this and more with TFS.

Focused on your needs, from study planning to completion

Clinical practice data may cover your disease awareness, real-world effectiveness, added value over competitors, and post-marketing safety needs, but sometimes you need a study design dedicated to Phase IV/Real-world evidence. The TFS RWE Algorithm can help. We offer a comprehensive range of services:

Prospective observational studies

Retrospective
chart reviews

Registries
(drug or disease)

Phase IV and
pragmatic trials

Cross-sectional (PROs, compliance, satisfaction, etc)

Database (new-user,
self-controlled case series etc)

Strong scientific, epidemiological, and technological expertise is crucial to conduct RWE studies of an increasingly wide range of designs successfully, efficiently, and with the highest scientific standards. You get it all by working with TFS.