monitoring

MONITORING

The sites where you need resources are potentially vast. Our clinical monitoring teams take on these responsibilities. Our teams will help you get faster, more efficient investigator site support and monitoring. Our CRAs bring strong monitoring and clinical experience to our customers with most of their experience in key therapeutic and specialty areas. In addition, each member is fully trained in FDA regulations, ICH guidelines, and GCP/SOP compliance.

As a result, our monitors thoroughly understand the many complexities associated with trials in the therapeutic area in which they primarily practice, in the region within which they work and accordingly, provide quality and performance feedback, study training and technical support, data query resolution, source document review, and site management for all types of visits.

The goal of Monitoring Ensuring that investigators are:

  • Appropriately selected.

  • Trained to complete the proposed protocol-driven research.

  • Able to observe proper patient protection standards.

  • Recruiting Eligible patients.

  • Compliance with protocol and required guidelines.

  • Verify that investigator and investigator’s team are adequately trained and comply with the protocol.

  • Verify that IRB/IEC operates and complies as per GCP, SOP and applicable regulatory requirements.

  • Monitoring the trial throughout specified duration involving monitoring visit to the trial sites.

  • Source data verification.

  • Informed consent form review, case report form review, investigational drug accountability, and adverse event review.

  • Ensuring all unused trial supplies are accounted for.

  • Writing visit reports, filing and collecting trial documentation and reports.