RWE Studies Using Primary Data Collection

Case Study: In response to a signal in animal studies of a potential association between teriparatide (for osteoporosis) and osteosarcoma, we are leading a 15-year surveillance study. As part of the project and to meet a regulatory commitment, we also designed and implemented a 5-year patient registry for the product.

To meet the requirements of risk management programs, inform drug development and post-approval strategies, or answer epidemiologic questions, we can help you design and implement real-world evidence research using primary data collection—including cohort studies and surveys of patients, physicians, or caregivers.

Prospective observational studies can help you: 

  • Understand the natural history of a disease and its treatment
  • Quantify and characterize product safety
  • Evaluate real-world effectiveness of a health care intervention
  • Understand outcomes from the perspective of patients, physicians, and caregivers
  • Evaluate risk management programs including REMS and EU-RMPs

Depending upon your research question, we work with you to identify and operationalize an efficient and effective design to yield the answers you need within your budget and timeline. Our services support all aspects of primary data collection for observational studies or secondary collection of chart data requiring special protection, including:

  • Serving as the scientific coordinating center:
    • Developing protocols
    • Writing analysis plans and performing analyses
    • Writing reports and manuscripts
  • Leading and coordinating:
    • Scientific advisory panels
    • Endpoint adjudication committees
    • Steering committees
  • Obtaining study approval from Institutional Review Boards and Ethics Committees
  • Managing study operations:
    • Site recruitment
    • Monitoring
    • Incentive management
    • Data collection (experienced with A-CASI, EDC systems, IVRS, phone interviews, web-based, paper/fax forms, interviews, chart abstractions, etc.)
    • Data management
  • Regulatory support including preparing reports and responses to regulatory questions for studies that are conditions of drug approval