Statistical consulting: program development plans, statistical evaluation of clinical trial design (analysis strategies, supporting methodologies etc.) according to ICH guidelines and GCP
Protocol design and review: clinical trials (phase I-IV), simulation and modeling studies, dose response studies, group sequential designs, adaptive designs, diagnostic studies
Sample size calculation
Case report form (CRF) and eCRF design and development
Randomisation schedule generation
Interim analysis planning
Statistical analysis plan (SAP)
Integrated summary for safety and effectiveness (ISS/ISE) according to sponsor’s requirements
Collaboration on ad hoc analyses, regulatory interactions, applications (IND) and annual safety
Statistical reports (including tables, figures and listings)
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