Primary Biostatistical Solutions
Primary Biostatistical Solutions is a biostatistical consultancy based in Victoria, BC, with over 20 years of experience in the clinical trials industry. They provide extensive biostatistical services for Phase I-IV clinical trials across various therapeutic areas, including study design, statistical analysis, programming, and data management, with a focus on CDISC-compliant datasets.
Industries
Nr. of Employees
small (1-50)
Primary Biostatistical Solutions
Victoria, British Columbia, Canada, North America
Services
Calculation of study sample sizes and power analysis for clinical trial designs.
Design of randomization and allocation procedures for clinical studies.
Statistical contributions to protocol drafting and study design decisions.
Preparation of detailed SAPs describing analysis methods, populations, and handling of data issues.
Development of analysis code and production of analysis datasets and outputs.
Creation of datasets compliant with regulatory clinical data standards for submission and analysis.
Calculation of study sample sizes and power analysis for clinical trial designs.
Design of randomization and allocation procedures for clinical studies.
Statistical contributions to protocol drafting and study design decisions.
Preparation of detailed SAPs describing analysis methods, populations, and handling of data issues.
Development of analysis code and production of analysis datasets and outputs.
Creation of datasets compliant with regulatory clinical data standards for submission and analysis.
Expertise Areas
- Clinical trial statistical design and analysis
- Statistical programming and dataset preparation
- Clinical data standards compliance and dataset mapping
- Generation of tables, figures, and listings (TFLs)
Key Technologies
- Statistical programming languages and environments
- Clinical data standards and dataset mapping
- Randomization algorithm design
- Sample size estimation and power analysis methods