Immunology

PRA is ideally positioned to provide our clients with effective leadership and strategic operational services for immunology studies. Our solid experience in this area affords us a thorough understanding of the treatment communities and patient populations of many key immunology disorders. PRA’s immunology therapeutic experts review each study proposal and develop customized recommendations to help our clients achieve their goals.

PRA HAS managed 100+ immunology studies over the past 5 years from transplants and autoimmune disease trials to rheumatoid arthritis, ulcerative colitis and Crohn’s Disease studies.

Value Added Solutions in Immunology

PRA offers critical success factors for each immunology study we conduct. We have a number of tools to guide our clients’ immunology programs:

  • experience in key indications such as rheumatoid arthritis and competitive indications such as Crohn’s disease
  • novel database analytics 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
  • enrollment validation process enables accurate assessments of site enrollment rates and facilitates patient identification
  • dedicated patient access unit facilitates integrated recruitment and retention services

Experience and Expertise in Immunology

PRA’s experience in immunology spans from early phase development through successful regulatory submission. We have a successful track record of managing immunology clinical development programs, as evidenced by the approval of 4 important drugs for which we provided critical services.

Core Areas of Immunology Expertise

In the past 5 years, PRA’s clinical development experience has spanned 14 indications, including these core areas.

Immunology No. of Clinical Studies No. of Clinical Sites No. of Clinical Patients
Rheumatoid Arthritis 23 247 1,599
Ulcerative Colitis 15 694 3,402
Autoimmune Disorder 15 86 987
Crohn’s Disease 12 844 10,304
Psoriasis 11 27 536
Total 76 1,800+ 16,000+