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.
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.
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.
The velocity with which data are being generated, as well as the volume and diversity of data sources will continue to increase exponentially. With new advancements in technology allowing for faster, less expensive, and more efficient data analytics, companies across every industry are investing resources to synthesize and garner data insights more rapidly. Addressing both the challenges and opportunities associated with “big data”, Evidera has launched Evalytica® – a scalable cloud-based software that delivers near real-time analysis and storage for huge volumes of real-world data. Evalytica® enables extraction of relevant real-world data from heterogeneous data sources and rapid analysis of treatment patterns, resource use and costs associated with a disease, and factors that determine outcomes.