Services

Clinical Trial Services

Bringing GCP to the Imaging Suite®

MedQIA provides a full range of CRO services and handles all aspects of your clinical trial from planning to completion. We specialize 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.

Study Initiation

  • 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

Study Management

  • 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
    • Detailed trackers
    • Summary reports

Image Management

  • 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

Image Reading

  • 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
    • Rapid data lock
    • Adaptive study designs

Advanced Quantitative Image Analysis

  • 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

Data Management

  • 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

Statistical Services

  • 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

Study Close-Out

  • Final data transfer
  • Study report
  • Record retention or transfer
  • Preparation of FDA submissions

Consulting Services

  • Medical and scientific consultation
  • Imaging physics consultation
  • Radiology consultation
  • Statistical consultation