Registries

Late Phase is dedicated to strategic development, management and delivery of Late-Phase Studies (including patient registries), utilizing integrated technology and centralized operational infrastructures:

• Bridging drug development and product commercialization
• Providing long-term safety follow-up of marketed drugs
• Building product awareness and demonstrating product value
• Strengthening product position in the market
• Extending product lifecycles

Experience

Under the leadership of this dedicated peri-approval services group, PAREXEL has experience with multiple national and global registry programs including over 50 registries within the past three years. These have involved over many hundreds of thousands of patients and tens of thousands of sites in North America, Europe, and Latin America. Therapeutic areas within the past three years have included: Oncology, Endocrine/Metabolism, Nephrology, Cardiovascular, Pain/Inflammation (including rheumatoid arthritis), Infectious Disease, Neurology, and Dermatology (including psoriasis).

PAREXEL Late Phase offers services to support the 3 major registry study types:

• Product-Specific Registries
  • Understanding ongoing clinical effectiveness of a product and/or outcomes
  • Supplementing safety data in a more robust fashion that spontaneous reporting
  • Understanding actual clinical usage
  • Assist health care practitioners familiarize themselves with a product
• Patient or Disease Registries
  • Provide data to understand the impact of a disease and its treatment
  • Interventions assessed may be select or all-inclusive
  • Serve as a vehicle for rich patient-perspective data
• Outcome Registries
  • Aid in the comparison of certain therapy to other standards of care
  • Provide data to support evidence-based decisioning in health care reimbursement strategies and formulary placement

Using registry studies as either primary or adjunct vehicles for pharmacovigilence 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 safety profile. These studies can provide long term experience and / or safety data at a significantly reduced cost per patient.

For more information, please contact the Late Phase Group.