Optimizing patient access with evidence of product value, effectiveness, and safety from early development through loss of exclusivity.

The Spring Issue of The Evidence Forum is Out

Read content related to the relevant issues facing companies along the path to approval and access

Everything Old is New Again: Classic Epidemiologic Concepts in a Pandemic Age

Margaret Richards, Senior Research Leader, RWE, revisits classic epidemiology concepts through a brief primer on pandemic-related topics

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Committed to Supporting Clients During the COVID-19 Pandemic

Access resources and information related to COVID-19 studies to discover how we are joining the COVID-19 fight

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Blog Post

Challenges With Uptake of Your Product? Implementation Science Could Be the Answer

Learn how implementation science can identify strategies to support accelerated adoption of innovations

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White Paper

The Need for Flexible Pregnancy Safety Studies: An Example in COVID-19 Vaccines

Gain insight into the current regulatory landscape related to pregnancy safety studies and discover various pregnancy study options

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Our Work In Action

150+ Drugs/Therapies

supported in the past year

30+ Global Extended Access Programs

in the last 3 years alone with thousands of patients transitioning smoothly from investigational to commercial

130+ Payer Submissions

across 20+ countries in the past 5 years, including reversal of multiple NICE decisions

17 of the 20 Top-Selling Drugs

in 2018 supported in the past 5 years

130+ Peer-Reviewed Publications

and 220+ research posters and presentations per year

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Latest Publications

Endocrinology

The Burden of Type 2 Diabetes and the Value of Achieving Near Normoglycemia from the Patient Perspective

Diabetes Therapy
June 2021

Infectious Disease

Twenty-Year Public Health Impact of 7- and 13-Valent Pneumococcal Conjugate Vaccines in US Children

Emerging Infectious Diseases
June 2021

Any

Comparison of ICD-9-CM to ICD-10-CM Crosswalks Derived by Physician and Clinical Coder vs. Automated Methods

Perspectives in Health Information Management
June 2021

What We Do

Real-World Evidence & Data Solutions

Obtain real-world evidence to optimize product value, effectiveness, safety, and market strategy by extracting data from existing sources, collecting primary data, and conducting hybrid studies.

Non-Interventional Studies

Robust design, epidemiologic and therapeutic area insights, advanced data analytics and precision study execution critical for study and program success.

Interventional Studies

Provide peri- and post-approval evidence via dedicated global operations and custom-tailored study designs.

Patient-Centered Research

Develop and evaluate clinical outcomes assessments to support labeling and promotional claims.

Evidence Synthesis, Modeling & Communication

Provide a truly connected value story, supported by strong evidence

Value & Development Consulting

End-to-end regulatory, clinical development, and value and access consulting services that span all phases of development.

Medical Writing

Expert medical writing, including medical information, study documentation, and publications, tailored to the peri- and post-approval environment.

In Our Own Words

Our work with clients, as well as through our partnerships with envelope-pushing, multi-stakeholder efforts such as the NEWDIGS LEAPS project and the Duke-Margolis RWE Collaborative, is helping to define the future of RWE in the healthcare space.

Debra A. Schaumberg, ScD, OD, MPH, Vice President, Real-World Evidence

Oncology – An Exciting Time of New Hope and New Challenges Feature Image

Case Study

Oncology Developer Utilizes Integrated Scientific Advice to Optimize Phase III Trial, Aligning Regulator and HTA Needs

Gain insight into how Evidera’s Value & Development Consulting team leveraged our Integrated Scientific Advice (ISA) offering to provide feedback to drug developers to optimize their evidence generation plans and satisfy stakeholder requirements.

Case Study

Six-Year Collaboration Across Six Indications for Groundbreaking Oncology Therapy

Evidera's Evidence Synthesis, Modeling & Communication team generated integrated packages of evidence, including value messaging, systematic reviews and comparative effectiveness analyses, and economic models, for six indications.

Case Study

Virtual Expanded Access Program Providing Breast Cancer Patients Early Access to Treatment During the COVID-19 Pandemic

Evidera was able to provide a virtual approach to mitigate the risk to patient safety during the COVID-19 pandemic and enabled early patient access to 400 US breast cancer patients ahead of commercial availability.

Case Study

Enhancing Oncology Market Access with a Real-World Evidence EAMS Add-on

Discover how Evidera researchers designed an observational study to conceptualize and implement real-world data collection in an Early Access to Medicines Scheme (EAMS) for an oncology therapy.

Case Study

Evidera Led Effort to Qualify the First Biomarker for COPD Trial Enrichment

Learn how Evidera's partnership with the COPD Foundation Biomarker Qualification Consortium led to the qualification of plasma fibrinogen as the first biomarker in COPD for enrichment of clinical trials by the FDA.

Careers

Meaningful Work at Every Level

We assess candidates across a variety of scientific and operational functions. From leaders in their fields, to those who are new to the industry. We employ people who have a proactive mind-set when it comes to the work they do and helping the people they work with.

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