Our Commitment to Quality Assurance
Our highest priorities are the quality of our work and adherence to regulatory requirements. PROMETRIKA team members have an in-depth knowledge of cGCPs and the ICH guidelines pertinent to study design, clinical trial conduct, data management, biostatistics and programming, as well as report writing and regulatory submissions. Our technical staff is cognizant of computer system validation issues and is well versed in relevant guidelines and regulations, including 21CFR Part 11. We have a complete set of standard operating procedures (SOPs) in place covering all aspects of our services and emphasize the importance of ongoing training for our staff. All of our deliverables, from locked databases to study reports and regulatory submissions, are subject to rigorous quality control and quality assurance procedures.