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.