MDU Quality Assurance (QA), an independent specialist within MDU, is responsible for ensuring the quality of the work provided by MDU, and that all work is conducted in compliance with applicable GCP guidelines, relevant regulatory requirements and applicable Standard Operating Procedures (SOPs).

QA is also responsible for the MDU quality management system and conducts internal system and project audits as well as vendor audits to ensure that vendors work to the same quality standards.

The MDU auditors have many years of clinical development experience and routinely conduct GCP audits.

Contract audit services

MDU QA also provides contract audit services for customers and these include:

  • Study audits
  • Investigator site audits
  • Trial Master File audits
  • Document audits (e.g., Protocol and ICF)
  • Pre-inspection audits
  • Writing, reviewing and updating SOPs