Our experts have extensive experience in designing and implementing patient registry programs, which provide information about patient experiences and a drug’s safety and effectiveness in a real-world setting. Registries can also help you successfully address post-approval regulatory requirements. We have experience with all types of registries (disease, product, pregnancy and safety), which are large, observational cohort studies that provide critical data for:
Understanding the natural history of a disease and its treatment
Evaluating real-world effectiveness and patient-reported outcomes
Obtaining drug safety and effectiveness information
Generating hypotheses to guide additional research
Evaluating the effectiveness of risk minimization programs
Quantifying and characterizing safety
Cultivating positive relationships with clinicians and patients
Establishing positions of leadership within therapeutic areas
Broad Registry Expertise and Operational Excellence
When developing a registry protocol, we draw from the expertise of our multidisciplinary teams in epidemiology, pharmacovigilance, biometrics, clinical operations, patient-reported outcomes and health economics. Our unique combination of epidemiology and pharmacovigilance expertise permits robust design, analysis and sensitivity to regulatory issues. Because we have such breadth and depth in our practice areas, you can be confident that your registry is planned and executed properly. Our registry strategies and implementation include:
Designing the most appropriate and efficient study to meet your needs
Defining and implementing appropriate data capture methods, including electronic data capture
Ensuring FDA-mandated 21 CFR Part 11 compliance
Providing professional project management
Implementing site training programs as appropriate
Recruiting sites
Recruiting and retaining patients
Establishing liaisons with appropriate scientific experts
Establishing a scientific advisory board
Managing safety reports to meet company and regulatory requirements
Our extensive data collection and management capabilities allow us to initiate projects quickly and implement them efficiently. Using a wide range of tools and systems, from personal interviews to leading-edge computer-assisted methodologies, our researchers collect and process the patient data required for the study. Additionally, our tracing unit has an excellent record of tracking subjects when retention rates are important but challenging.
