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.
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