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Clinical Development

  • Provide strategic input to the design and analysis of clinical protocols and clinical development plans, including operational and outsourcing considerations

  • Participate in the creation of clinical protocols and clinical development plans

  • Prepare and/or review statistical sections of protocols

  • Prepare and/or review statistical analysis plans for submission to regulatory agencies

  • Provide review and evaluation of statistical analyses, clinical study reports, and integrated summaries

  • Provide statistical expertise as a member of data safety monitoring committees

  • Provide due diligence review of clinical trial information for in-licensing and acquisition decisions

  • Provide a statistical and operational perspective to development strategies as a member of scientific advisory boards

Regulatory/Legal

  • Provide strategic input, review, and evaluation of regulatory submissions from an experienced statistical perspective

  • Provide statistical/operational considerations for regulatory agencies

  • Serve as the company's statistical representative to regulatory agencies if that expertise does not exist internally

  • Plan strategy for meetings with FDA and other regulatory agencies, including presentations to FDA advisory committees and participation in mock FDA advisory committee meetings

  • Provide technical expertise and expert testimony related to litigation

Capture.PNG

  • Assist the sponsor in planning and negotiating with contract research organizations

  • Provide an interface between the sponsor and contract research organizations

  • Conduct in-house courses in various statistical topics such as experimental design and sample size estimation

Training/Outsourcing

Our Services

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