Quality Assurance

Quality is essential to all aspects of our company, and it’s engrained within each department. At Trial Runners, we guarantee that quality services are provided to our clients on all levels throughout each study. We have an established and independent Quality Assurance department that provides our clients the assurance of clinical trial integrity and subject safety.  The Quality Assurance department has established planned and systematic actions that are in place to:

  • Ensure management of compliance with the protocol, SOPs & GCPs
  • reduce data queries
  • identify ways to reduce cycle times for various processes
  • ensure data integrity throughout the study’s course and that the data collected are the data required by the protocol
  • ensure the accuracy and consistency of data from entry into the CRF, to final datasets reported in the final CSR
  • identify and help resolve instances of nonconformity while carrying out clinical trials

Quality of Trial Runners’ processes is assured through:

  • Routine SOP training following an established training matrix
  • SOP Committee ensures routine review and creation of SOPs, standard forms and templates and procedural documents
  • SOP Deviations
  • CAPAs
  • Protocol Exceptions and Violations
  • Archiving
  • External Audits
    • Vendor/Consultant qualification audits
    • clinical Investigative site audits
    • Sponsor and Regulatory inspections
  • Internal Audits
    • Process audits
    • process QC reviews
    • departmental system audits
    • key deliverables or study components
    • study process documents
    • trial master file reports, tables and listings
    • IT System validation and security checks

Our Quality Assurance Committee is responsible for the review of Quality Metrics, communicating quality concerns and initiatives to the SOP Committee and other operational departments. This assures departmental cooperation and compliance with QA processes