At ProTrials, Quality Management is not a department, it is a way of life. It is ingrained in our culture and reflects how we conduct our business. We understand the importance of ensuring that a clinical trial is conducted, recorded, and reported in accordance with the protocol, written procedures, Good Clinical Practices (GCP), applicable country/local laws and regulatory requirements. Quality, however, is more than that to us. We strive to continually put forth our best effort in everything we do. It is important because of who we are and for those that we are ultimately doing it for – the patients. As a company, our Quality Assurance (QA) Department can conduct site audits as well as provide FDA audit readiness preparation. If needed, additional support to prepare sites for audit readiness can also be supplied. Our QA Department also diligent vets our vendors to ensure that they meet our qualification requirements so that nothing is left to chance.
ProTrials’ study teams collaborate and communicate with their sponsor counterparts to ensure full transparency and quality throughout the study. Integrated Quality Risk Management processes and plans are used to ensure that a risk proportionate, data-driven approach has been developed based on the design of the clinical trial as well. Internally, there are quality control activities and processes in place to ensure that ProTrials activities are properly and compliantly being executed. Our independent Quality Assurance (QA) Department performs routine assessments of our services to ensure we are compliant with our internal standard operating procedures (SOPs), Good Clinical Practices (GCPs), FDA regulations and ICH guidelines.