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.
- 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).
- 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.
- 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.