Biostatistics Services

Data Monitoring Committee (DMC) Services

Statistical support for safety review and DMC meetings

The Data Monitoring Committee (DMC) is an integral part of many clinical studies. SDC provides expert statisticians to analyze your data for safety review and DMC meetings.

DMC Experience in Multiple Therapeutic Areas

  • Oncology
  • Infectious Disease
  • Immunology
  • Ophthalmology
  • Gastroenterology

Development of Stopping Rules For

  • Futility
  • Superiority
  • Equivalence

Development of Stopping Rules Using

  • Alpha spending functions
  • Conditional power
  • Group sequential designs

Independent Reporting Statistician

  • Present safety and efficacy results during closed session
  • Facilitate discussion through therapeutic area expertise and in-depth knowledge of data
  • Prepare closed session minutes

Voting Statistical Board Member

  • Determine appropriateness of interim analysis methodology
  • Interpret complex efficacy analyses for medical board members
  • Identify additional analyses to further explain ambiguous results

Other DMC Statistics Services

  • Charter development/authoring
  • Unblinded DMC team independent of internal or external blinded study team
  • Table, listing, figure development and production
  • Rapid turnaround of ad hoc requests
  • Integration of pharmacovigilance data