In this context, as a client, you expect:

  • Positive, results orientated work environment, building partnerships and modeling teamwork,
    communicating to the team in an open, balanced and objective manner
  • Ownership for all project activities, which are related to the monitoring function
  • Identification and qualification of potential investigators to ensure that the sites
    have adequate time and can fulfill their obligation to the study
  • Preparation and submission of Regulatory and EC issues or providing support for undertaking Regulatory and EC submissions.
  • Site initiation visit including site personnel training and close out visit
  • Regular on-site monitoring
  • Preparation and submission of visit reports in a timely manner according to mca SOPs or client SOPs as required
  • Regular follow-up letters to the investigators and study personnel
  • Ongoing training to the site personnel with regards to ICH-GCP guidelines, our mca SOPs,
    or the client SOPs to ensure the quality and integrity of the data
  • Ensuring effective and timely coordination of the supply of clinical materials to the site
  • Source data verification, drug accountability and data collection) in accordance with ICH-GCP guidelines,
    client policies and SOPs, and regulatory guidelines
  • Query management, SAE editing
  • Etc.


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