Quality Assurance
Quality Assurance
Quality Is in Everything We Do
Quality at ProTrials is a way of life; it is ingrained in our culture and reflected in the way we do business. Our commitment to quality means that each clinical study is conducted, recorded, and reported in accordance with clinical study protocol, Standard Operating Procedures (SOP), International Conference on Harmonisation (ICH) Good Clinical Practices (GCP), and applicable country or regional regulations. Driven by detail, our Quality Assurance (QA) department conducts investigator site audits and provides regulatory authority inspection readiness preparation – additional support to prepare sites for audit readiness is also available. So that nothing is left to chance, QA diligently evaluates vendors to establish that they meet our qualification requirements.
ProTrials study teams collaborate and communicate with sponsor counterparts for full transparency and quality throughout each study. Integrated Quality Risk Management processes and plans are used to develop a risk-proportionate, data-driven approach based on the design of the clinical study. Internally, quality control activities and processes are in place so that ProTrials activities are properly executed. Our independent QA department performs routine assessments of our services to confirm we are compliant with our internal Standard Operating Procedures (SOPs), ICH GCPs, and regulatory authority guidance.
ProTrials quality assurance services can be tailored to meet your needs.
We offer the following suite of QA services:
- Site audits/GCP audits
- Study specific audits
- FDA inspection readiness/mock inspections
- Vendor audits
- SOP reviews
- SOP writing assistance