You want clinical study design and protocols that balance the interests of multiple stakeholders without breaking the bank. NAMSA brings together experts—clinical, regulatory, statistical, marketing and health economics—and puts them to work for you. Our team approach maximizes your study design, combining speed and expertise.

Common Assignments

  • Clinical hypothesis consultation
  • Endpoint selection and confirmation
  • Statistical sample size calculation
  • Protocol writing
  • Protocol review
  • Resource planning
  • Cost estimation
  • Case report form (CRF) design
  • Literature review
  • Regulatory counsel
  • Health economics planning
  • Sample size calculations and power analysis
  • Literature search and summary
  • Randomization scheduling
  • Statistical and analysis planning for clinical trial protocols
  • Protocol writing and review
  • Preparation of draft IDE submission, including protocol summary
  • Participation in pre-IDE interactions with FDA
  • Submission of IDE to FDA

Our senior-level experts regularly advise on the necessity, implications, and practicality of clinical study design factors. The breadth and depth of their combined expertise brings efficiency to the process—helping you realize the full potential of your protocol.