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