Trial Design and Analysis

We have extensive expertise in the design, analysis, and interrogation of clinical trials, including pharmaceutical, biologics, and device registration trials. This knowledge comes from hands-on experience that encompasses a broad range of perspectives, including:

  • Design and management of registration trials from within pharma
  • Regulatory review of protocols and application data from within FDA
  • Conduct of intervention trials and rigorous cost-effectiveness assessments as academic investigators and research methodologists

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