MED-NET uses the skills and experience of medical doctors to design the study from the very beginning:
• Design the idea and the hypothesis of the study;
• Sample size calculation;
• Design the study protocol;
• Prepare the Patient Information Form;
• Prepare the Informed Consent Form;
• Prepare the Case Report Form;
• Prepare other patients materials (if applicable);
• Prepare the medication labels (if applicable);
• Prepare randomization rules and randomization envelopes;
• Prepare the other study documents necessary for specific protocol (ex. Adaptations or validations of evaluations scales etc.).
All study related documents prepared by MED-NET are compliant with ICH-GCP guidelines and applicable EU and Polish law regulations.