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Monitoring

Monitoring

Clinical trial specialists of Vita Aeterna company provide the full range of services on checking of subject safety, compliance with the protocol, GCP, national legislation and quality of data collection.

Services:

  • Making qualification visits, initiation visits, routine monitoring visits, site closure visits;

  • Effective interaction with study sites;

  • Making investigator trainings;

  • Checking patient informed consents;

  • Checking patient compliance with the protocol criteria;

  • Checking the Investigator file for provision of adequate maintenance and document storage;

  • Checking study sites data including source documents and completed CRFs;

  • Collection of study documents including regulatory documents;

  • Accountability of a study drug and comparator;

  • Tracking patient enrollment status in each site;

  • Checking SAE reports;

  • QUERY management; 


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