With a complete biostatistics services at our core, Biofortis can answer and fit your needs to complete full services offer in clinical trial.
Our biostatistics experienced team is fully involved from the earliest phases of your project. Taking into account your needs in term of high-quality results and your timelines, we can provide insights into your clinical trial design, help you define study outcomes and identify potential sources of bias.
Our biostatisticians can provide full support and help you to determine the best pathway to product approval:
- Protocol development
- Sample size calculation to ensure to ensure the correct detection of the expected clinically relevant effect at a given significance level
- Randomization schedule
- SAS programming
- Support in writing of scientific papers
- Independent audit of your programs and analyses.
Additionally, upon request, our biostatistics staff can run meta-analysis but also other customized studies.
Our SAS-certified biostatisticians are fully trained in standard (GCP-ICH) and advanced statistical methodologies: parametric and non-parametric approaches, mixed models, Generalized Estimating Equation (GEE) models, multiplicity issues, survival analyses, etc.
The biostatistics team at Biofortis is fully engaged in the development of new solutions and approaches based on the latest statistical methods and related regulatory references. Our statisticians are experienced in interacting with all the stakeholders of a project and they are usually solicited to communicate on behalf of our clients.