Quality Assurance

Quality Assurance

Quality every step of the way

Quality is integral to all aspects of our business. At ProTrials, 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. To ensure that quality services are provided to our sponsor-clients, quality is embedded within each ProTrials department. There are quality control activities and processes in place to ensure that ProTrials activities are properly and compliantly being executed. ProTrials’ study teams collaborate and communicate with their sponsor counterparts to ensure full transparency and quality throughout the study.

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. QA also conducts internal audits, trial master file audits, and vendor qualifications audits to ensure that quality is embedded into the preparation, maintenance, and conduct of a study and processes are being followed according to requirements and protocols.