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Biostatistical Services.

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Mobius Medical’s experienced biostatistician provide statistical services in the following fields.

Clinical Trial Design:

  • Provide statistical expertise in designing clinical trials and protocol development.
  • Review statistical section of the protocol.
  • Provide expertise in sample size estimation to make optimal use of limited resources.
  • Provide randomisation schedule which prevents bias in subject allocations.

Data management:

  • Provide statistical input in data management plans
  • Work closely with data manager on electronic data capture (EDC) and case report form (CRF) development.
  • Data review and validation.

Data Analysis and Reporting:

  • Prepare statistical analysis plan (SAP).
  • Prepare shells for TLFs (table list and figure).
  • Write clinical study report (CSR) using appropriate statistical analyses.
  • Provide independent statistical programming to validate the statistical outputs (TLFs).

Study Monitoring:

  • Optimal evaluation of ongoing clinical trials e.g., interim analysis.
  • Prepare project specific documents following standard operating procedures and protocol.

Observational and Epidemiological Studies:

  • Provide high level statistical support to clinical and basic science researchers.

Data Modelling:

  • Conduct statistical modelling such as linear/non-linear regression modelling, mixed-effects modelling, survival analysis, regularized regression.

Statistical analyses are conducted with appropriate reproducible programming software using SAS & R.

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