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Biostatistics Services

Biostatistics Services

The staff of the Department of Biostatistics have experience in the design and analyses of clinical trials ranging from parallel group designs, cross-over designs, equivalence designs and sequential designs.

Our Biostatistical services can be customized to your individual needs ranging from programming as per your analysis plan, to in-depth Biostatistical support.

Our Biostatistics services include the following:

  • 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
  • Unscheduled interim analyses
  • Post-hoc and exploratory analyses
  • Formal interim and final analyses
  • Statistical consulting

Biostatisticians follow 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 ACDMC Coordinator.

Upon project closure, our QA process assesses compliance with study specific SOPs.

Supported by our IT systems and integrated SOPs, our Biostatisticians are able to accommodate:

  • Client defined analysis standards
  • 3rd party databases
  • Programming support for varying reporting formats and standards
  • Changes to Protocol, CRF template and project specifications
  • Timely response to ad-hoc requests
  • Collaboration with 3rd parties for report and manuscript writing

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.

Software used: SAS, R, STATA, SPSS and SUDAAN

Clinical Study Reports and manuscripts

To augment our Biostatistics services, we prepare clinical research reports and manuscripts. Our complete study documentation includes the research report with summary tables and graphics, clinical data listings and computer output of statistical analyses.

Our SOPs and training programs are designed to ensure that the representation and interpretation of study results are consistent with the Protocol, Statistical Analysis Plan and study data. Our scientific and medical writers are committed to ensure the clarity and accuracy of all reports and manuscripts.

The following is a list of clinical research report and manuscript writing services we offer:

  • Clinical Research Reports:
    • Statistical Reports
  • Interim efficacy reports
  • Reports on post-hoc/exploratory analyses
  • Integrated Summary of Safety and Efficacy Reports.
  • Abstracts and Manuscripts:
    • Medical writing
    • Editing for publication
    • Graphics and visuals