Ideally, as soon as your product arrives in Phase II, for the writing of the synopsis and the calculation of the number of patients. Your full dossier will thus benefit from an optimum methodological quality. However, it is better late than ever and improvements can always be made, such as with complementary analyses or fine interpretations of the results of completed studies.
If your company does not have in-house biostatistics skills, it is difficult and risky to outsource this strategic part without being in control. The CROs are not here (in general) to develop an appropriate methodology but to apply THE methodology defined in the protocol or a standard methodology.
If you have this expertise in-house, it might sometimes be helpful to have a second notice or unload some projects from your department.
Consulting hours/days are charged in real time, at the end of the month. You will not pay for the months during which your project did not require any biostatistics activities.
Before any performance, a strict confidentiality agreement is signed between the parties.
SAS ® 9.4 or later – EAST ®
Inter-company training takes place in Lyon or Paris. Intra-company training takes place within the company’s premises.
