Quality Through the Eyes of Experts

Quality Assurance

As international and federal regulations become increasingly stringent, the need to ensure compliance has never been more important to research program success. Quality must be built into clinical research programs and our quality experts know how to ensure compliance. In clinical research, effective quality assurance (QA) is an integral part of every quality system. From the development of policies, procedures and work instructions to the implementation of ongoing oversight programs including audits and corrective and preventive action (CAPA) plans, QA is needed to meet regulatory agency and industry-driven requirements.

With over 20 years of GxP auditing experience, our auditors are trained and ready for hire. We can conduct operational assessments, perform gap analyses, audit for compliance or help to implement quality systems. As an approved Independent Review Organization (IRO), MedTrials can also assist with compliance program planning and implementation. Let our QA experts help to ensure inspection readiness.

Services include:

  • GxP audits (Clinical investigator, sponsor, CRO, SMO & IRB)
  • CAPA management and consulting
  • Clinical database/data verification audits
  • Clinical study document reviews
  • Compliance consulting
  • Due diligence audits
  • Gap analysis
  • Governance program consulting
  • Mock regulatory inspections
  • Performance metrics, scorecards and quality-risk indicators
  • Pharmacovigilance system audits
  • Quality management system (QMS) planning and implementation
  • Quality agreement development
  • Quality plan development
  • Quality system audits
  • Regulatory inspection readiness planning
  • Risk management
  • Standard Operating Procedure (SOP) development
  • Vendor assessment/qualification