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 ongoing 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 studies.