The services offered by Biossec will achieve various objectives depending on the client’s needs : e.g. a complete biostatistical outsourcing from the protocol to the clinical study report
or only a few days specific tasks, ensuring the best quality of biostatistical deliverables, flexibility and speed of services...
Acoording to your needs, Biossec can provide one or several of the following services :
• Statistical methodology for clinical protocols,
• Sample size (calculations, simulation with various scenarios, ...) ,
• Statistical methods including adaptive approaches,
• IWRS Randomsation,
• Statistical Analysis Plan,
• Programming in SAS or R,
• Statistical Analyses,
• Handling of statistical issues (missing data, multiplicity),
• Statistical writing,
• Quality control using a repeated process (Plan, Do, Check, Act).
In our experience, we have worked on more than 80 clinical study protocols (phase I to IV, PMS and PASS) with various designs (parallel/cross-over, superiority/non-inferiority, ..) and statistical methods (Analysis of Covariance, Nonparametrics, Repeated Measures, Survival Analysis, Group Sequential Methods, Exact Methods, Propensity Scores, ...).
We propose to use our SOPs and standard templates. However, we can also use the Client’s SOPs and modify our templates to the project needs.