Clinical strategy and implementation


Our team is experienced in the preparation of clinical investigation submission for European competent authorities. medidee supports you in preparing the following documentation:

  • Ethical comitee submission
  • Patient Informed Consent forms and other patient support documents
  • CRF (Case Report Form)
  • Essential requirements based on the MDD 93/42, or other directives
  • Risk management according to ISO14971
  • Identification of applicable standards
  • Design of clinical instruction for use and labeling
  • Documentation of the Investigator brochure in accordance with international standard EN ISO 14155-1 point 7.2
  • Design of the contract between you and the sponsor/investigator
  • Preparation of the notification form to Competent Authority in all EU

 


GCP and ISO 14155 audit


Should your documentation be already available we conduct a gap analysis of your clinical investigation system.


Clinical investigator selection and preparation


Should you need to select the correct clinical investigation centers, we will support you in identifying the right partners to execute the investigation and to monitor your data.


On-site monitoring


During the clinical phase, our experts audit the investigation sites to check for compliance and for a high quality data