Clinical Quality Assurance

QA activities are essential for successful product development in compliance with with all GxP regulations. Quality assurance managers ensure that clinical trials are conducted based on the highest standards, patient safety and data integrity.

Our systematic quality assurance methodology allows any potential issues to be identified and resolved at an early stage. Our QA is both consistent and dynamic, and trial procedures are adjusted to changing expectations and requirements as the study evolves.

We offer QA services that cover your needs from early development to post-marketing.

Flexibility, experience in multidisciplinary projects and a thorough knowledge of the applicable legislation are the major strengths of our department.

Quality Assurance services

• Writing/review/update of SOPs on GxP regulated activities
• Assistance with ISO 9001:2015 certification
• Assistance with GDP certification requirements for medical devices
• Personnel training on GxP
• Internal audits
• Vendor audits
• Consultation and follow-up of CAPAs

Quality assurance tasks for clinical trials

• Training of Investigators and site staff on GCP
• Investigational site audits
• Trial Master File Audit
• Database/Data Management Audits
• Statistics/TFLs Audit
• Conduct and evaluation of central and/or local laboratories