Planning

• Drawing up of the study protocol (according to ICH-Guidelines or sponsor's requirements), of CRFs and of RDE-applications if required
• Working statistical models and methods out to decide and to generate hypotheses, definition and reasoning of a clinically relevant difference, sample size determination, drawing up of the data management plan and the statistical analysis plan
• Design and set up the data base
• Generation of a RDE application according to study protocol, CRF and data management plan
• Production of the Investigator's Brochure
• Generation of randomization lists by SAS (with respect to strata if necessary) and drawing up of emergency envelopes
• Acquisition of investigators, of patients and/or subjects and assembly of a DSMB and other boards to supervise the trial
• Contracting with all external persons, companies and institutes that participate in the trial
• Contracting patient's/subject's insurances
• Organisation of investigator meetings
• Training of investigators and study nurses
• Submission to ethic's committee and authorities (discussion, correction)
• Recruitment and integration of central labs and reference centres and organization of drug accountability