Early Development Services (Phase I-IIa)

Market Trends with Randall Hein (Vice President, Early Development Services)

PRA's Early Development Services (EDS) group provides comprehensive services for Phase I and Phase IIa studies, including:

• Phase I and IIa clinical research
• Bioanalytical research
• Data support

Our client base spans a wide array of pharmaceutical and biotech companies in the United States, Europe, and Japan. EDS conducts more than 100 complex studies and over 200 bioanalytical studies yearly for studies recruiting healthy volunteers or special patient populations.

Our active pool of over 30,000 study participants provides us with a large base of loyal volunteers, and our Phase I/IIa operations in Central Europe provides access to hospital based patient populations. Study populations include:

• Healthy volunteers
• Special populations:
  • elderly
  • post-menopausal women
  • sterilized healthy females
  • overweight/obese subjects
• Populations with specific medical conditions:
  • renal impairment
  • hepatic impairment
  • diabetes mellitus
  • asthma
  • COPD
  • allergic rhinitis
  • hepatitis-C
  • dyslipidemia
  • Parkinson's disease
  • rheumatoid arthritis
  • psoriasis
  • cardiovascular diseases

PRA's clinical facilities are located in the United States, The Netherlands and Central Europe. Our bioanalytical facility is located in The Netherlands. Over 500 specialists working from seven different countries make up PRA's Early Development Services team. Throughout our range of services, we comply with Good Clinical Practices, Good Laboratory Practices, Good Manufacturing Practices, and International Conferences on Harmonisation regulations.

With over 100 years of combined early phase experience, our EDS leaders and scientists deliver for our clients in the areas of:

• Feasibility assessments
• Protocol design
• IMPD and CRF development
• Recruitment
• Data management
• Pharmacy services, including manufacturing
• Clinical conduct
• Bioanalysis (PK/PD) including biomarkers
• Data analysis
• Clinical study reports
• Medical writing
• Regulatory support