Bio Soft Research is renowned for our employees' depth of experience in SAS programming and Biostatistics. Our SAS programming and Biostatistics services usually involve producing statistical analysis plans, generating tables, listings and figures, and performing statistical analyses. Bio Soft Research also offers the option of immediate responses to your short-term statistical needs. Typically, our statistical consultancy services focus on protocol design, calculation of sample sizes, power calculations, and/or the production of a study randomization.
Biostatistics and SAS Programming Include:
- Statistical Analysis Plan (SAP) and Output Shells – we optimize the use of our Consultant Statisticians to ensure innovative approaches to the statistical content of a study to increase the chances of a successful trial.
- Clinical Data Interchange Standards Consortium (CDISC) – using CDISC standards ensures that the data used in the outputs produced complies with regulatory standards.
- Output Production – using Bio Soft Research standard macros within the SAS ® Programming system ensures increased efficiency when producing outputs.
- PK/PD Analysis - modeling the relationship between exposure and response using nonliner models and nonlinear mixed effect modeling.
- Production of Statistical Report/Clinical Study Report – our statistical and medical writing teams collaborate to produce high quality reports.
- Interim Analysis / Data Safety Monitoring Boards (DSMBs) – we offer unblinded statistical support and advice for Interim Analyses and DSMBs.
- Meta Analysis – our expert Statisticians can advise on potentials for bias during a Meta Analysis as well as on statistical methods to use.
- Standardized approach for analysis files.
- Transportable tools to support standard non-efficacy reports
- Programming based on analysis data
- Independent quality reviews
- Customized clinical data outputs
- Proactive, results-oriented approach to programming
- Programming for integrated summary of safety and efficacy
- Adoption of sponsor’s programming (SOP) Preparation of Case Report Tabulations (CRT) for submission
- Programming based on data validation plan
- Programming of tables/listings/figures for clinical study report and data monitoring committee