Clinical Monitoring and Site Management

We are committed to provide experienced and well trained trial monitors.

The DRC trial monitors perform comprehensive site management and monitoring activities including all types of monitoring visits.

All activities are performed in accordance with ICH-GCP to ensure all investigational sites are compliant with all applicable regulations and protocol requirements.

In addition to on-site responsibilities each trial monitor is responsible for site management documentation and follow-up activities to ensure that site staff remains motivated and focused.

The DRC trial monitor plays an important role in the successful conduct of the study. The relationship developed between the trial monitor and the site staff is focussed on open and effective communication, providing training and support to ensure patient safety, data quality and maximize patient enrolment.

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IN GENERAL WE PROVIDE:

  • Study initiation, monitoring and close-out activities
  • Provision of comprehensive study updates and monitoring reports
  • Creation and management of tracking tools for enrolment, essential documents, monitoring, patient and/or CRF tracking, drug accountability, queries and adverse events, including SAE
  • Maintenance of study documentation, Case Report Forms, investigational products, clinical supplies, etc
  • And much more!

Interested? Get in touch!