PLANNING A CLINICAL TRIAL

• Protocol design and writing
• Investigator and laboratory selection and qualification
• Support in hospital contracts and other agreements
• Contacting Competent Authorities and Ethics Committees

DOCUMENT PREPARATION FOR SUBMISSION TO COMPETENT AUTHORITIES AND ETHIC COMMITTEES

• Investigator’s brochure
• Investigational product dossier (IMPD) for drugs
• Technical file/essential requirement list for medical devices
• Patient information, Informed consent
• Case report form (eCRF via vendor)

BEFORE STARTING THE CLINICAL TRIAL

• Site feasibility and qualification on behalf of the sponsor
• CRA selection for study monitoring
• Monitoring tools development, including monitoring plan
• Safety management plan
• Risk management plan
• Set up of Agreements

DURING THE CLINICAL TRIAL AND AT END

• Study management
• Biostatistics and data management (outsourced)
• Clinical trial quality system and quality assurance (eTMF via vendor)
• Safety monitoring including medical advice
• Clinical study report writing