Clinical Operations – Contract Research Organisation Our dedicated team of medical doctors, scientists, clinical project managers and clinical research associates handles projects from protocol design to clinical study report.

PLANNING A CLINICAL TRIAL

• Protocol design and writing
• Investigator and laboratory selection and qualification
• Support in hospital contracts
• 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 or paper CRF)

BEFORE STARTING THE CLINICAL TRIAL

• CRA selection and study monitoring
• Monitoring tools development, including monitoring plan

• Safety management plan

DURING THE CLINICAL TRIAL AND AT END

• Study management
• Biostatistics and data management (outsourced/ recommendation)
• Clinical trial quality system and quality assurance
• Safety monitoring
• Clinical study report writing

SWISS LOCAL SERVICES  
Swiss clinical trial representative for foreign companies located outside of Switzerland.