We are experienced therapeutic professionals delivering expertise, effective leadership, and strategic operational services to immunology clinical studies.
Our experience in immunology spans early-phase development through successful regulatory submission. This solid experience affords us with a thorough understanding of the treatment communities and patient populations with many key immunology disorders.
Core areas of immunology expertise
We have conducted 150+ immunology studies in recent years in wide-ranging indications. Our successful record of managing immunology clinical development programs has resulted in the approval of five important drugs for which we provided critical services.
Value-added solutions in immunology
Our immunology therapeutic experts review each study proposal and develop recommendations to help our clients achieve their goals, and we have a number of tools to guide our programs:
Novel database analytics to facilitate strategic country and site selection
Country-focused approach to start-up activities and in-depth knowledge of regulatory considerations
Strong relationships with immunology sites, renowned experts, and leading investigators worldwide
An enrollment validation process that yields accurate assessments of site enrollment rates and facilitates patient identification
recruitment and retention
A dedicated patient access group that facilitates recruitment and retention services
Autoimmune diseases are inherently complex and heterogenous requiring highly skilled specialists. When working with PRA, our partners have access to some of the best experts in their field:
- A team of board-certified rheumatologists with expertise in clinical aspects and leading drug development from FIH Phase I to Phase IV within autoimmune and inflammatory disorders. This team possesses extensive academic experience in the diagnosis, treatment, and clinical research of diverse autoimmune and inflammatory disorders
- Physicians with extensive collective experience in the roles of Principal Investigators as well as Lead Medical Directors for global trials on both the Sponsor and on CRO side
- Expertise in autoimmune disease clinical manifestations, current therapeutic drugs, and scientific mechanism of action of compounds under investigations
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