Based on our expertise and experience, we use the specific statistical tools required for clinical or bioequivalence studies in line with applicable guidelines (EMEA/CVMP/816/00 and 016/00).

Anistème can provide the following services:

• Advice on methodology
• Choice of experimental set-up.
• Calculation of the number of subjects required
• Production of randomisation lists and envelopes.
• Writing of protocol statistical section
• Use of Spotfire® S+ (Tibco® Software Inc.) and R statistical package.
• Programming of the statistical analysis.
• Statistical analysis and interpretation of the results
• Statistical reports writing