evidera.comOptimizing access with evidence of value, effectiveness, and safety
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Title:Optimizing access with evidence of value, effectiveness, and safety
Description:Evidera provides evidence-based solutions to demonstrate the real-world effectiveness, safety, and value of biopharmaceutical and biotechnology products.
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Contact Us Search Who We Are About Us Experts Executive Team Who We Work With Contact Us What We Do Real-World Evidence & Data Solutions Non-Interventional Studies Interventional Studies Patient-Centered Research Evidence Synthesis, Modeling & Communication Value & Development Consulting Strategic Value & Access Consulting Strategic Regulatory & Clinical Development Consulting Medical Writing Thought Leadership Therapeutic Expertise Centers of Excellence Investing in Innovation Our Publication: The Evidence Forum Publications Resource Center News & Events Upcoming Conferences Webinars News Room Careers Overview Current Opportunities Diversity and Inclusion Internships Optimizing patient access with evidence of product value, effectiveness, and safety from early development through loss of exclusivity. Learn More Latest News The Fall Issue of The Evidence Forum is Out Read content related to the relevant issues facing companies along the path to approval and access Read Now Advanced Degree Internships Explore current advanced degree internship opportunities for Summer 2021 Be part of innovation at Evidera as you earn your master’s or doctorate by collaborating on initiatives at the forefront of clinical research Learn More Latest News 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 Learn More Upcoming Webinar The Importance of Flexible Pregnancy Safety Study Solutions: An Example in COVID-19 Vaccines Tuesday, March 23, 2021 | 10:00AM EDT Register Now Perspective Paper What Does It Take to Achieve a Major Benefit Rating by the G-BA? In this new perspective paper, our Value & Development Consulting experts discuss what it takes for your product to achieve the rarely granted major benefit rating by the German Federal Joint Committee (G-BA). Read Now 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 Learn More Latest Publications Respiratory Dual-Combination Maintenance Inhaler Preferences in Asthma and Chronic Obstructive Pulmonary Disease: A Patient-Centered Benefit-Risk Assessment Respir Med March 2021 Endocrinology Cost-Effectiveness Analysis of Empagliflozin versus Sitagliptin as Second-Line Therapy for Treatment in Patients with Type 2 Diabetes in the United States Diabetes Obesity & Metabolism March 2021 Gastroenterology Cost-Effectiveness of Tofacitinib Compared with Infliximab, Adalimumab, Golimumab, Vedolizumab and Ustekinumab for the Treatment of Moderate to Severe Ulcerative Colitis in Germany Journal of Medical Economics February 2021 Read More About Our Publications 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 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. Read More 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. Read More 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. Read More 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. Learn More © 2021 Evidera, a PPD business. All Rights Reserved Privacy Policy Legal Notices +1 301 654 9729 (US) +44 (0) 208 576 5000 (EUR) Site Map Twitter LinkedIn...
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