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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.

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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)
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BEFORE STARTING THE CLINICAL TRIAL

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

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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.

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