Biostatistics

Credible results from your study

SCiAN's Biostatistics department has an average of 14 years of experience in the design and analysis of clinical trials.  Our experience ranges from parallel group, cross-over and Bayesian designs to complex (population) pharmacokinetic- and dynamic evaluations, therapeutic equivalence testing and large variable sample size sequential designs.

We customize our biostatistical services to the Sponsor's needs ranging from SAS programming as per your analysis plan, to in-depth biostatistical support of your registration trials.  For registration trials, we can develop optimal designs according to therapeutic area-specific regulatory guidelines; provide client representation at IND meetings in support of the designs and analysis plans and develop full SAPs resulting in a complete "submission-ready" clinical research report with supporting documentation.

Our Biostatistics service offerings include:

  • Study design
  • Analysis and reporting of pre-clinical and Phase I-IV clinical  trials of various designs to match the objectives of the study
  • Randomization - envelops, fax or web
  • Periodic data monitoring and safety reviews (DSMB)
  • Unscheduled interim analyses
  • Post-hoc and exploratory analyses
  • Formal interim and final analyses
  • Statistical consulting.