Study planning

For the efficient preparation of a clinical trial, we provide – among others – the following services:

• Conception of the study design
• Appointment of the head of the clinical trial
• Biometrics/sample size calculation
• Conception of the questionnaire
• Conception of the patient education documents and declaration of consent
• Taking out clinical trial insurance
• Selection of suitable trial centres
• Conception of the monitoring plan
• Preparation of the study documentation
• Preparation of official application documents
• Obtaining approvals from the competent Ethics Committee and the competent federal authorities; registration of the clinical trial with the local supervisory authorities
• Financial planning
• Preparation of contracts/agreements