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Due-Diligence Services and Products

  • Extensive Experience in Due-diligence from Both Sides
    • The perspective of the company/individual with potential interest in acquisition
    • The perspective of the company/individual with a product to be acquired or to be negotiated in a partnership
  • Due-Diligence Review Services
    • Review of data package
    • Review of adequacy of data bases per ICH and FDA expectations, including CDISC
    • Review of adequacy of safety data and adequacy of efficacy data
    • Review of quality of data base relative to CRFs
  • Review of Reports
    • Consistency of results in report with computer-generated displays
    • Consistency of in-text tables/figures/listings with computer-generated TFLs
    • Relational consistency of data displays
    • Consistency of synopsis with report
  • Product Reviews
    • Consistency of results as depicted in the report of a study with results depicted in other reports or summaries
    • Consistency within summaries of one section with another, text with in-text displays
  • Audit Functions
    • Audit of data bases
    • Audit of reports
    • Audit of summaries or other documents
    • Preparation of audit grid
    • Preparation of audit plan
    • Execution of audit
  • Due-Diligence Products
    • Executive report of due-diligence findings
    • Presentation of highlights of due-diligence findings
    • Summaries of studies and available key results

 

 

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