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– Passive 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

  • Over

    50%

    Operations staff with RWE experience
  • Nearly

    250

    Studies
  • Nearly

    100,000

    Patients in RWE and Phase IV Studies
  • Nearly

    7,000

    Sites
  • Studies performed in

    19

    Countries
  • Over

    25

    Clients
  • Over

    300

    Healthcare data sources in the
    EU and NA
  • Over

    60

    Transnational databases
  • Over

    20

    Ongoing collaborations with data owners

Virtual studies a solution in time of COVID-19

The COVID-19 pandemic has placed a spotlight on the necessity of virtual trials. In particular, real-world evidence studies are ideally suited for virtual or decentralized studies due to their typically large number of geographically dispersed participants and longer observation periods. Thankfully, there is an increasing spectrum of validated systems and devices to gather endpoints for clinical trials across all therapeutic areas.

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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)

Working with us, you benefit from specific GPP-aligned procedures, robust design, and analysis expertise. Our strategic consultancy adds scientific and commercial value to the study. If you’re looking for excellence in any therapeutic area, we offer first-rate operational delivery, from the simplest to most complex projects.

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.

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RWE Team and Network

TFS RWE offers a large pool of staff that can be assigned to RWE studies. We have a dedicated team trained in specific procedures and GPP, a global Site Network Database and KOLs with experience in observational studies

  • Neus Valveny, PhD, BSc

    Senior Director, Head of Real World Evidence

    • Over 20 years' experience in clinical research
    • Involved in the planning and execution of 100+ RWE studies including primary and secondary data from all therapeutic areas
    • Strong scientific background including expert epidemiological and statistical knowledge
    • Expert on RWE study design, medical writing and statistical analysis of RWE studies and clinical trials.
    • She is member of the international STRATOS (STRengthening Analytical Thinking for Observational Studies) and OHDSI (Observational Health Data Sciences and Informatics)
    • PhD in Biology; certified by the European Medical Writers Association: published 20 articles as an author and 35 articles as an acknowledged medical writer.