Comprehensive QA and Communication
We support proactive communication, strict process monitoring, and project-specific inspections of all deliverables to assure high-quality data and reporting. We provide timely notification of errors in image quality and labeling to minimize mislabeled or non-evaluable images. We also provide reports on site compliance and critical findings in routine deliverables to provide transparency into project status and product performance.
Elements of our quality assurance program include:
- Site compliance monitoring on image acquisition and transfer.
- Electronic tracking of missing, mislabeled, and non-evaluable images.
- Prompt notification, investigation, and resolution of discrepancies.
- Standard reporting on image quality for each modality and visit.
- Study-specific inspections of image analysis data prior to delivery.
- Investigation of outliers, trends, and noteworthy findings.
- Prompt notification of suspected AEs and product failures.
- Systematic reliability testing and reader performance monitoring.
- On-time delivery monitoring and project performance review.
- Proactive CAPA program and emphasis on continuous improvement.
Experienced and Responsive Project Managers
Studies are supported by a skilled team of experienced staff and managers dedicated to quality and customer service. We assign a Lead Project Manager (LPM) to each study as the primary point of contact for day-to-day communication and management. A Backup Project Manager (BPM) assures continuity in communication in the event of illness or absence. A dedicated Technical Production Team (TPT) administers the study QA program and provides technical support to the LPM and BPM. An Account Manager (AM) oversees the client relationship and assures total satisfaction with our services.
Our team has many years of experience in clinical research, and more than two-thirds have advanced degrees in science, engineering, management, or public health. We pride ourselves on our responsiveness, entrepreneurial culture, and willingness to go “above and beyond.”