• Trial Design
• Clinical Affairs
• Regulatory Affairs
• Quality Assurance

Quality Assurance

Quality Assurance is an integral part of clinical project management and Databean’s QA team is knowledgeable and intensely committed to ensure that our clients Quality Systems comply with FDA Quality System Regulations as well as ISO 13485/MDD Standards. We are available to perform audits in the following areas:

• GMP
• GCP
• IRB’s
• Vendors
• Pre-FDA inspections
• site compliance, and
• sponsor/CRO

Upon completion of the audit(s) we will help our clients determine areas of regulatory risk and propose and implement strategies to reduce such risk.

If you would like to know more about our capabilities or have a project you would like to discuss please call 845 278 0576 or email us.