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.

 

Barbara Geiger, BSN, RN

Barbara has been in the clinical research and development industry for over 25 years. She is an executive clinical operations professional with extensive experience in oncology and CNS drug development.

Nikolas Burlew

Nik is a Regulatory and Strategic Development QA professional working under GMP and GLP regulations providing auditing, training, system development, and project management services, in addition to authoring CMC sections for US and EU applications.

Marie Hanley

Marie has worked in the clinical research industry for over 28 years. Over the past 9 years, she has been in global regulatory and quality assurance roles.

Mark Shapiro

A pharmacologist by training, Mark has almost 20 years of experience spanning virtually all aspects of drug development. Mr. Shapiro completed an MBA at Duke University’s Fuqua School of Business.

Roger Morgan, M.D.

Dr. Morgan has extensive experience in global medical affairs with both pharmaceutical companies and CROs. While trained as a surgeon/critical care intensivist, he spent much of his industry career focused on cardiovascular research.

 

  • 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

 

 

  • 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%

 

 

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

 

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