Patient registries

Patient registries are one type of observational research design that is utilized by biopharmaceutical and device sponsors to:

• bridge their product development and product commercialization efforts;
• track and document long-term product effectiveness and safety after market approval;
• build product awareness and to demonstrate product value among reimbursement and physician stakeholders;
• strengthen product positioning and clinical messaging in the market; and
• extend product lifecycles

Furthermore, using registry studies as either primary or adjunct vehicles for pharmacovigilance activities is increasing in the wake of high-profile product withdrawals and growing questions on whether the spontaneous adverse event reporting system is providing sufficient data upon which to assess a product's long-term safety profile in routine clinical practice.

Patient registry experience

PAREXEL is dedicated to the strategic development, management, and delivery of Patient Registries utilizing an integrated technology platform and centralized operational infrastructures. Under the leadership of this dedicated services group, PAREXEL has experience with multiple national and global registry programs, including over 50 registries within the last three years alone. These have involved over hundreds of thousands of patients and tens of thousands of physicians in North America, Europe, and Latin America. Therapeutic areas have included: Oncology, Endocrine/Metabolism, Nephrology, Cardiovasculr, Pain/Inflammation (including rheumatoid arthritis), Infectious Disease, Neurology, and Dermatology (including psoriasis).

In addition, PAREXEL has provided services to support

• Product-Specific Registries that document long-term clinical effectiveness, supplement safety data in a more robust fashion than spontaneous reporting, and help health care practitioners to better understand product usage in a real world setting;
  
• Disease-Specific Registries that provide data to assess the impact of a disease on a specific patient population and to track treatment options and outcomes; and
• Outcome Registries that aid in the comparison of a specific therapy to other standards of care, which can provide data to support evidence-based decision making within multiple health care settings

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