Biostatistics Services

  1. Sample Size Calculations

    2. ClinDatrix will utilize statistical expertise to generate sample size calculations for clinical investigations for any phase of the drug or device development cycle.

  2. Randomization

    3. Randomization schedules based on the protocol design will be produced by ClinDatrix utilizing SASTM software.

  3. Clinical Trial Design

    4. ClinDatrix can assist you with the trial design of your clinical investigations.

  4. CRF Design

    5. ClinDatrix will impart statistical knowledge and expertise into the CRF Design for clinical investigations for any phase of the drug or device development cycle.

  5. Statistical Analysis Plan

    6. ClinDatrix will prepare a complete Statistical Analysis Plan that includes a detailed description of all statistical analyses to be carried out on the data collected during the clinical investigation. Mock-ups of tables, listings, and figures will also be part of the Statistical Analysis Plan.

  6. Project Specific Documentation

    7. ClinDatrix will follow its Standard Operating Procedures for any statistical services provided to its clients. As required, ClinDatrix will work in conjunction with its clients to prepare Protocol Specific Procedures.

  7. Patient Evaluability

    8. Prior to unblinding a blinded clinical trial and prior to the commencement of the analyses of data from a clinical investigation, ClinDatrix will work in concert with our clients to determine and finalize the patient evaluability rules based on the clinical protocol.

  8. Statistical Programming

    9. ClinDatrix will subject all statistical programs to validation prior to delivering statistical tables, listings, and/or figures to clients. Validation will be either through independent review of programming code by a statistical programmer or statistician different from the one who generated the original programs, or through an independent generation of statistical programming code by a different statistical programmer or statistician.

  9. Statistical Tables, Listings, Graphs

    10. Statistical tables, listings, and graphs will be generated by ClinDatrix according to the statistical analysis plan and to the statistical section of the protocol. Any differences between the statistical analysis plan and/or the statistical section of the protocol will be detailed in the statistical and/or clinical report.

  10. Statistical Report

    11. ClinDatrix will produce a statistical report in conjunction with the preparation of a full clinical report. The statistical report will provide a description of the findings of the statistical analyses for the clinical investigation and will confirm that the analyses were conducted per the statistical analysis plan. Deviations from the statistical analysis plan or additional unplanned analyses will be fully described in the statistical report.

Back To Top