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Real-world evidence

Optimize your RWE with a scientifically rigorous, data agnostic approach

As the value of real-world evidence (RWE) to regulators, prescribers, and payers continues to grow, you can rely upon our therapeutic, methodological, and global dataset expertise to maximize its value to stakeholders.

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Our real-world evidence services and RWE studies include:

  • RWE strategic advice
  • Study design methods expertise
  • Natural history, burden of illness, and unmet need
  • Comparative effectiveness analyses
  • Drug utilization and treatment patterns assessments
  • Clinical trial design and extrapolation augmentation
  • Pharmacoepidemiology and drug safety studies
  • External control arms (ECAs)
  • Expert data source consultation
  • Dashboards and visualizations
  • Data landscaping assessments and selection expertise
  • Research medical coding support
  • Evidence synthesis
  • Scientific communications
RWE solutions

Data-agnostic expertise

From early development to commercialization, you need the right data to support your evidence needs. Whereas some providers are limited by the datasets they use, our fit-for-purpose, data-agnostic RWE expertise allows us to apply our knowledge of all relevant datasets to provide strategic advice and better demonstrate the value of your products.

For over 13 years, we have:

  • Curated an international team of 100+ RWE specialists in epidemiology, biostatistics, analytics and automation, and pharmacoepidemiology and safety
  • Comprehended the strengths and limitations of global real-world data (RWD) sources across therapeutic areas, having utilized 40+ unique data sources on behalf of clients
  • Established deep knowledge of global markets and payer/regulator needs
  • Secured impactful results for hundreds of life sciences companies
  • Established a powerful reputation for scientific rigor and methodological expertise
  • Developed peer-reviewed publications across a wide range of therapeutic areas, including in oncology, cardiology, neurology, infectious diseases, respiratory, and hematology. See our publications list for examples.
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Ask the right questions, leverage the right data

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Data agnostic

Untied to specific data sources and with extensive knowledge of global data, we are ideally placed to provide expert, independent advice and impactful real-world evidence services and RWE studies.

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Our real-world evidence experts are highly experienced at delivering confirmatory analyses across a variety of global datasets.

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The depth of our dataset expertise guarantees that only precise evidence needs drive our selection of real-world data.

Real-world evidence disciplines

We deliver strategic advice and impactful evidence solutions to our clients by leveraging each of the core RWE disciplines.

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Our epidemiologists are subject matter experts who offer scientific leadership throughout a project, including planning, executing and communicating the study design, applying appropriate methodology, and interpreting the results for all RWE deliverables. Our experts can assess the strengths and limitations of any RWE study, including the choice of data sources.

Ask about epidemiology


Experts in the statistical methodology used in clinical and RWE studies, our biostatisticians work within our multidisciplinary teams to deliver subject matter expertise on study design, methodology, and result interpretation with a focus on mitigating potential bias, developing statistical analysis plans using the latest methodology, and providing oversight to ensure results are of the highest quality.

Ask about biostatistics

Analytics and automation

Our analysts utilize tech-enabled data programming (R, SAS, Python, SQL) and statistical analysis support to generate robust insights from real-world data. We also apply automation and standardization to maximise efficiencies, and provide comprehensive medical coding research. Combining expertise in statistical analysis, data manipulation, and programming, our analysts transform raw data into actionable intelligence.

Ask about analytics/automation

Pharmacoepi & safety

Our specialized pharmaco-epidemiologists offer expertise in the strategic planning and application of epidemiological methods for regulatory decision-making studies with a focus on safety. Our team offers study design expertise in all relevant topics, including external control arms, label expansions, natural history studies, and comparative effectiveness analyses; plus rigorous critical reviews of study documents.

Ask about pharmacoepi/safety

Find out how our data-agnostic expertise can optimize your real-world evidence studies

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RWE Dashboards

Are you making the most of your data?

The integration of human expertise and transparent, scientifically rigorous technology platforms can revolutionize real-world evidence services and RWE studies.

Our interdisciplinary scientific team will design, build, and implement fit-for–purpose RWE Dashboards that transform complex data into digestible insights that are rigorous, transparent, and impactful.

Other technology platforms leveraged by our expert teams include EVID AI for literature reviews; RPR to secure stakeholder insights; and IEP platforms to support evidence planning, organization and communication.

Explore our technology

Interactive RWE Dashboards

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Flexible Integrated Teams (FIT)

Real-world evidence research partnerships reimagined

If your real-world evidence (RWE) studies would benefit from an agile relationship, our optional FIT engagement model provides access to dedicated, cross-functional teams that integrate seamlessly within your own team to supplement existing resources or fill experience gaps.

Whether you need epidemiologists, analysts, biostatisticians, automation experts, or a broad mix of RWE expertise, the size and composition of your FIT can gradually evolve or pivot quickly to meet your changing needs, all without the costly delays involved in adjusting a statement of work.

A trusted extension of your organization, our team becomes your team.

Learn more

Developing external control arms for regulatory and HTA agencies

The use of external control arms (ECAs) remain a challenging proposition that requires expertise to navigate.

We offer a specialized multidisciplinary team with years of experience in ECA design and execution. Our team brings a deep understanding of the common criticisms raised by reviewers; a strong track record of scientific leadership in this area; and a data-agnostic approach that ensures we use only fit-for-purpose data.

Team members Jen Wogen and Craig S. Parzynski recently presented on this topic at ISPOR 2023.

Ask a question or request slides

Selected RWE publications

Our team members have co-authored publications across a range of therapeutic areas, data sources, indications, and methods. A selection can be seen below or view more on our online publications list.

TitleGR Author(s)YearTherapeutic AreaData SourceJournal/ConferenceFull Citation & Links
Real-world characteristics of patients with wild-type transthyretin amyloid cardiomyopathy: an analysis of electronic healthcare records in the United States.Crowley A, Benjumea D2023CardiologyOptum EHRAmerican Journal of Cardiovascular DrugsView
The current landscape and emerging applications for real‐world data in diagnostics and clinical decision support and its impact on regulatory decision making.Surinach A, Pashos CL2022General Medicinen/aClinical Pharmacology & TherapeuticsView
"Real-world" outcomes and prognostic indicators among patients with high-risk muscle-invasive urothelial carcinoma.Surinach A2021Oncologyn/aUrologic Oncology-Seminars and Original InvestigationsView
View our full publication list

Genesis Research Hub


Explore our publications for details of our peer-reviewed research and therapeutic experience.


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Case studies

How our approach, expertise, and research capabilities have impacted upon our clients' success.


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111 River Street, Suite 1120
Hoboken, New Jersey 07030, US