North American Services & Experience

With more than 65,000 active clinical trials and the largest market for drug and medical device products, North America is a very important region to life science firms (regardless of their location). Our team provides the right expert guidance and operational execution across the spectrum of drug and medical device development – from regulatory strategies and filings to clinical services and development to GxP compliance, and post-marketing research.

We are headquartered in Research Triangle Park, NC, USA, with additional offices in Overland Park, Kansas and Boulder, Colorado. Within these offices we deliver a full array of outsourced regulatory, strategic development, clinical development, and post-approval services.

 

Local Services

  • Biostatistics
  • Clinical Monitoring
  • Data Management
  • Global Study Feasibility
  • GxP/CMC Quality Assurance Consultancy
  • Patient Recruitment
  • Pharmacovigilance & Safety surveillance
  • Project Management
  • Regulatory & Strategic Consultancy
  • Regulatory Submissions & Filings
  • Site Selection & Management
  • TEMPO eClinical Platform

By Therapeutic Area

  • Oncology: 33%
  • Central Nervous System: 11%
  • Cardio/Metabolism: 10%
  • Dermatology: 7%
  • Orthopedic: 6%
  • Infectious Diseases: 6%
  • Gastroenterology: 6%
  • Rheumatology: 4%
  • Eye and Ear: 4%
  • Nephrology/Renal: 3%
  • Immunology: 3%
  • Other: 4%

By Phase

  • Phase 1: 16%
  • Phase 2: 28%
  • Phase 3: 20%
  • Phase 4: 15%
  • Registry: 16%
  • Other: 5%

 

 

 

 

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