Biostatistics SciAn Services has a dedicated biostatistics department. Our staff has experience in the design and analysis of clinical trials ranging 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. Our biostatistical services can be customized to your individual 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 services include the following: |
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Study design • Analysis and reporting of pre-clinical and Phase I-IV clinical trialsof 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. |
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SciAn Services’
Biostatisticians and SAS Programmers follow corporate SOPs to ensure
the consistency and integrity of study results. We have a multi-stage
procedural and scientific QC process. Our procedural QC process
involves periodic review of programming standards (program structure,
notation, unit testing and electronic filing of programs). Our scientific
QC process involves reviewing the scientific integrity of the analyses
by the Project Director (to ensure the consistency of the Protocol
vs. SAS databases vs. SAP vs. statistical results). Upon project
closure, our QA process assesses compliance with corporate and study
specific SOPs.
Our flexibility in accommodating changes to project specifications is paralleled with a complete audit trail; while maintaining quality of study data and adhering to expected study timelines. Back to Services Overview Page Download Corporate Brochure |
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