Project Management & Quality Assurance

Comprehensive QA and Communication

MMI supports proactive client communication, strict process monitoring, and routine inspections to assure high-quality data and reporting. We provide timely notification of discrepancies in image labeling, subject/visit demographics, and compliance to the image acquisition protocol. We provide routine updates on site performance and study progress, and we conduct thorough QC inspections per audited SOPs, validated work instructions, and ISO 9001:2008 quality standards.

Our quality assurance program includes the following elements:

  • Routine in-process inspection and monitoring at each processing step.
  • Monitoring of compliance to the image acquisition and transfer protocol.
  • Routine notification of discrepancies and recommended corrective action.
  • Site performance reporting, including rate of missing or un-evaluable images.
  • Verification of image quality per predefined quality metrics and acceptance criteria.
  • Technical inspection of outliers, trends, and noteworthy findings.
  • Prompt notification of suspected adverse events or critical deviations.
  • Thorough technical and logistical training for all project staff.
  • Systematic reliability testing and performance monitoring.
  • On-time delivery score card and project performance review.
  • Routine quality audits conducted by 3rd-party auditors.
  • Proactive CAPA program and emphasis on continuous improvement.

Experienced and Responsive Project Managers

Studies are managed by a team of skilled and experienced project managers dedicated to superior quality and customer service. Each study is assigned a Lead Project Manager and one or more Technical Project Managers for QA support. Our project management team has many years’ experience in clinical research, and more than two-thirds have advanced degrees in science, engineering, or public health. Our managers’ unique combination of operational and technical expertise ensures that sponsors have an experienced contact for all study-related needs. We pride ourselves on being extremely responsive to client requests and go “above and beyond” to exceed expectations.

Want to learn more? Browse our services and therapeutic expertise, or contact us.