Quality Assurance Support Services

Quality Assurance Support Services

The Quality Assurance program aims at providing regulatory oversight to the investigators and their study teams to promote research compliance and provide education and training. CTO will work at drafting the quality assurance/quality improvement plan tailored to the requirements of each study and its study team.

CTO has established Standard Operating procedures for each of below mentioned services that comply with the MCW and CHW IRB requirements, ICH-GCP and federal regulations.

  • Conduct routine audits
  • Conduct for–cause audits
  • Conduct audits at sites other than MCW/FH for multi-site studies
  • Conduct mock-FDA inspections
  • Develop and implement CAPA (Corrective and preventive action plans)
  • Assist in preparation for an external audit
  • Consultation to Investigator and Sponsor-Investigators who do not have an established monitoring and quality assurance plan for their studies

To request our services, please complete and submit the form below.

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