Investigational site quality cannot be achieved through monitoring alone. It has to be built into the site’s processes; therefore, we invest significant effort and time in helping our Investigators implement effective Quality Management Systems (QMS), which then become an important input for our risk-based monitoring process.
In addition to the usual QMS elements - written procedures, quality control, internal audit program, staff training, etc. - our Project Managers have access to the site’s internal QMS effectiveness metrics and use these data to assess risk and determine the frequency and intensity of monitoring. We control the performance of our clinical research sites by changing the focus from inspection-based quality improvement to planned systematic quality management.
We provide our Investigators with extensive training, on-site/remote consulting services, and templates for most QMS-required documents, e.g. Clinical Quality Management Plan, SOPs, QC Plans, Audit Plans, Reports and Checklists, etc. Likewise, we guide site staff towards the development and implementation of performance metrics, which we then review periodically.
We thus assure data integrity and accuracy, subject safety, and regulatory compliance during our studies and strong long-term partnerships with our Investigators.