A GROWING NEED FOR REAL-WORLD EVIDENCE
Real-world evidence of safety, effectiveness and value is necessary to achieve successful market access and product uptake. In addition to robust early development clinical trial programs, payers and other key stakeholders, such as patients, physicians and caregivers, demand evidence of benefits and risks in a real-world setting. Peri-approval designs contribute to the characterization of burden of illness and unmet need – which are essential to better understand the potential clinical, humanistic and health economic impact of a novel treatment or device. These studies are also important inputs to quantitative health economic models and evaluations necessary for reimbursement. Post-approval, non-interventional studies are also important for on-going value demonstration, evaluations of comparative effectiveness and the vigilant monitoring of drug safety.
Evidera’s team of researchers offer leadership in the design and execution of studies to meet payer and regulator evidence requirements. We offer diverse scientific methods, and high quality project and data management expertise. Methods include analytics of secondary data sources, bespoke multi-national data collection, hybrid studies, and pragmatic/adaptive studies.
WE CAN HELP YOU:
- Delineate the natural history and course of disease (e.g., incidence, prevalence, standard(s) of care)
- Determine unmet clinical, and humanistic needs by characterizing the burden of illness
- Collect robust data from rare disease populations
- Quantify real-world product-specific and/or comparative safety, effectiveness, adherence and other outcomes
- Evaluate country-specific treatment patterns, quantify associated costs of care, and populate health economic models
DEEP DATA INSIGHTS
Evidera does not limit its analyses to a proprietary database. Instead, we remain focused on your research questions and provide optimal solutions inclusive of a diverse array of real-world data sources. Our integrated team of health economists, epidemiologists, biostatisticians, and clinicians critically assess the available databases to identify those that will yield the best information to address your research needs. We have a deep understanding of, and experience with, data sources from more than 20+ countries including in North America and Europe, and other regions as needed (e.g., Brazil, Japan, Korea, China, Australia, Taiwan). We understand and can analyze large claims databases and electronic medical records as well as combinations of these and other data sources.
GLOBAL OBSERVATIONAL STUDIES AND REGISTRIES TO MEET PAYER AND REGULATOR REQUIREMENTS
Achieving optimal market access and effective commercialization requires custom-tailored study designs, deep expertise, and access to worldwide patient populations. Our understanding of the post-approval environment combined with decades of experience in product development—spanning early stage, product launch and post-approval support—translate into a proven ability to deliver effective study designs that are tailored to meet the specific objectives, marketplace needs and regulatory requirements of your product. Furthermore, our operational model is tailored to meet project-specific goals and stakeholder expectations with expert input from medical, clinical, project management, regulatory, payer, and epidemiological functions.
Our multi-disciplinary team of experts designs and executes studies that result in tailored, multi-national, fit-for-purpose patient-level datasets. Bespoke data may be used to characterize burden of illness and unmet need, aid in the development and implementation of PRO instruments, evaluate health care patterns and associated costs, populate quantitative health economic models, or monitor drug safety.
EXCELLENCE IN STUDY DESIGN AND EXECUTION
- Extensive experience – dedicated real-world, non-interventional study operations, regulatory and global clinical supply teams with over 25 years of experience across ~116,000 patients and ~15,000 sites globally in the past 5 years
- Specialist medical affairs team – significantly beat industry benchmarks in study start-up and patient recruitment time when working under an early engagement partnership model
- Therapeutic area experts – capabilities across a wide range of indications, and ability to leverage our network of clinicians and global operations professionals
- Integrated partnership model – flexible and proactive operating and governance model customized to unique needs
- Innovation through technology and collaborations – alliance with Healthcore; Preclarus; Acurian and Radiant; mHealth, eConsent
REAL-WORLD EVIDENCE OFFERINGS
- Database Analytics
- Social Media Analyses
- Real-World Data Identification
- Advanced Statistical Modeling, Predictive Analytics and Machine Learning Approaches
- Post Hoc and Exploratory Analytics of Trial and Observational Data
- Coding Algorithm Development
- Patient or Physician Surveys
- Hybrid Database and Direct-to-Patient Studies
- Time and Motion Studies
- Medical Chart Review Studies
- Prospective HEOR Studies
- Disease, product and pregnancy registries
- Post-authorization Safety and Efficacy Studies (PASS and PAES)
- Risk Management Plans (RMPs) and Risk Evaluation and Mitigation Strategy (REMS) Programs