Quality Assurance

Our Quality Assurance (QA) procedures ensure that high standards are maintained at every step of your clinical program, fully aligned with global regulations and sponsor requirements. Leveraging digital workflows, automated compliance monitoring, and risk assessment, we enhance efficiency, precision, and regulatory compliance across all clinical operations.

Quality assurance is embedded in everything we do. Our comprehensive Standard Operating Procedures (SOPs) guide and train staff while ensuring operations comply with ICH-GCP, ISO 14155, ISO 20916, and other applicable standards. By combining regulatory expertise with digital tools, we help sponsors navigate complex clinical landscapes while maintaining patient safety, ethical conduct, and data integrity.

Our Quality Assurance services include:

• Personnel training & competency management through digital learning platforms
• Risk assessment and mitigation using predictive analytics
• Internal safety and incident management with automated CAPA tracking
• Vendor identification, qualification, and digital oversight
• SOP and policy development with workflow automation for version control
• Audit and inspection readiness supported by real-time compliance dashboards
• Regulatory compliance
• Post trial/study activities

Our dedicated QA team uses technology-driven approaches to monitor, evaluate, and continuously improve clinical operations—ensuring regulatory adherence, data accuracy, and ethical standards throughout the study lifecycle.