Quality Assurance Services

Quality Assurance (QA) activities should occur throughout the entire clinical trial implementation period–not just at the end of a study as a means to identify issues. EndPointe offers the following services to assure quality implementation of clinical studies:

• Standard Operating Procedures (SOPs):
  • Generation of a standard set of SOPs governing clinical activities
  • Review and updates to existing SOPs to match current organizational structure, titles and responsibilities
  • Assessments of SOP compliance and training
• Staff Qualifications and Training Audits:
  • Inspection of current training systems and documentation and provide remediation recommendations
  • Provide training services on SOPs and Good Clinical Practice
  • Provide protocol or other study specific training services (monitors, study staff, etc.)
• Vendor Pre-Qualification Inspections:
  • Work includes scheduling and conduct of a on-site vendor visits which includes a facility tour, SOP and quality system review and a detailed report
• Pre-study Qualification Site Visits:
  • Feasibility assessments through questionnaires
  • On-site review of potential clinical trial sites
• Trial Master File Audits:
  • File reviews to ensure compliance with regulations
• Site Audits:
  • During the clinical trial to identify issues and define corrective action
  • At the completion of a study in preparation for regulatory audits
• Vendor Audits (Contract Research Organizations, Drug Distribution Systems, IxRS):
  • Interim audits to ensure vendors are working according to the agreed upon plans and to review updated procedures and qualifications of assigned vendor teams
• Clinical Study Report Quality Control
  • Review of a all reported data within a CSR to ensure accuracy against final tables and listings