Designed to Produce

Clinical Monitoring

Clinical Monitors are the front line of clinical research. The CRAs are pivotal in determining a study’s success (as measured by recruitment, data quality and issue management). The Stiris team of knowledgeable CRAs will ensure the sites are supported and motivated to provide the cleanest data possible in the shortest time possible.

All CRAs are trained to our extensive SOPs to ensure quality and consistency of services such as:

  • Site identification/feasibility
  • Site qualification visits
  • Site activation
  • Site Initiation Visits
  • Informed Consent review and process review
  • Review of site SOPs, policies and procedures documentation
  • Ongoing monitoring of site/study recruitment, eligibility, source document verification
  • Site Study Coordinator mentoring services available
  • Data collection (electronic or paper)
  • Query resolution
  • Safety reporting (Adverse Event and Serious Adverse Event reporting procedures)
  • IP review, accountability and return/destruction
  • Investigator Site File review and reconciliation
  • Site audit preparation assistance
  • Site Close-out Visits

We are strong communicators and ensure you have as much relevant information at your fingertips as possible.

So you can successfully adapt to the changing challenges and priorities over the different project phases.