Monitoring

  • Carrying out all stages within tight dead-lines
  • Complete reporting
  • Own clinical site

Clinical trial monitoring is the process of ensuring that clinical trials are conducted, documented, and reported according to the Protocol, GCP rules, standard operating procedures, and institutional requirements.

The purpose of monitoring a study is to verify that:

  • Subjects’ rights and welfare are protected.
  • The data submitted is accurate, complete, and supported by primary documentation.
  • The study is conducted by the approved current version of the protocol/amendments, GCP, and regulatory requirements.

X7 Research has been conducting monitoring visits since 2010, both on-site and remotely in Russia, EAEU, CIS, EU. The key points of our specialists’ work are the implementation of thorough data control, as well as constant interaction with the client

SITE SELECTION VISIT

SITE INITIATION VISIT

ROUTINE VISIT

SITE CLOSE-OUT VISIT

All monitoring visits are conducted by ICH GCP standards, monitoring plan, Standard Operating Procedures (SOP) requirements, protocol, and client wishes.

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