Patient Registries (Cohort Studies)

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.

Deliverables

• Study design and protocol
• Recruitment materials
• Advisory committee coordination
• IRB review and approval
• Adverse event reporting
• Data analysis and reporting
• Publications