Services
Clinical Trial Services
Bringing GCP to the Imaging Suite®
MedQIA specializes in delivering cutting-edge quantitative imaging biomarkers in Phase I through IV studies for drugs and in medical devices.
Our competitive advantage is in combining a responsive Clinical Operations team with clinicians and scientists in imaging physics, computer vision, biostatistics, oncology and radiology. This depth and breadth of expertise means you can partner with MedQIA with confidence for all aspects of your clinical trial.
- Imaging acquisition parameter
- Imaging physicists with modality specialization
- Imaging protocols tailored to specific study objectives
- Dose calculations
- Optimized standard of care imaging
- Multicenter standardization of advanced imaging acquisition
- Investigator meeting presentations
- Site surveys and qualification
- Imaging core manuals
- Site-specific tailoring to scanner models
- Site training
- Imaging central files
- Imaging charter development
- Site management and monitoring
- Image tracking and quality control
- Rapid question/query resolution
- Scan time point verification and reconciliation
- For scheduled and unscheduled imaging
- Image tracking
- Image transfer
- Flexible options including web-based upload, secure FTP, CD/DVD
- Tailored to trial to minimize costs to the sponsor and maximize capture rate
- Image de-identification capabilities provided to sites
- Image storage and archiving
- DICOM image storage
- Data center with fully redundant backup
- Image receipt and quality control
- Scan receipt logging
- Image QC report issued for every scan
- Metrics and monitoring with ongoing feedback to maintain quality
- Subspecialty fellowship radiologists
- Reader selection, training, and qualification
- Reader management and support
- Support for external, sponsor-requested radiologists
- Standard imaging endpoints
- Utilizing proprietary semi-automated measurement tools to increase reproducibility
- Advanced computer-aided quantitative imaging endpoints
- Validated analysis algorithms and software
- Dual reader paradigms with adjudication
- Rolling read paradigms
- Specialization in cutting edge computer-aided image analysis techniques
- Proprietary suite of quantitative imaging biomarkers
- Study-specific customization with validation and compliance
- Experience with FDA submissions involving advanced imaging endpoints
- Imaging databases for standard endpoints and customized for trial needs
- Quality control and cleaning during rolling reads
- Rapid data lock following receipt of last scan or data cutoff
- Data transfers
- Transfer plans and format specification
- Flexible file formats and secure protocols
- Support for interim, data freeze, and data lock transfers
- Biostatisticians specializing in advanced image analysis
- Study design with imaging endpoints
- Including adaptive trial design
- Power calculations to reduce size of cohorts based on image enrichment of populations
- Final data transfer
- Study report
- Record retention or transfer
- Preparation of FDA submissions
- Medical and scientific consultation
- Imaging physics consultation
- Radiology consultation
- Statistical consultation
