Our Services

Clinical Quality Assurance

Our clinical quality management team will ensure your study withstands regulatory scrutiny and adheres to FDA Good Clinical Practice compliance guidelines from study inception to database lock. Our team operates with a sense of urgency to proactively identify early quality events and provide a prompt resolution, resulting in the sustained momentum of your study to meet targeted deadlines.

The services we provide include: trial specific audits, root cause analysis, corrective and preventive action plans, development of QA and quality improvement plans, quality documentation reports, serious adverse event coordination, validation of quality process, central study TMF audits and determining system requirements for your study.