Clinical Imaging Services

Imaging Services

Imaging services for clinical trials are the core of our business. We have extensive experience in most imaging modalities across hundreds of clinical trials. With a staff of more than 30 practicing, sub-specialty-trained radiologists and strategic relationships with the world’s leading research institutions, we can provide the expertise and the capacity for any-sized trial.
A doctor looking at clinical imaging

Startup Activities

Trial start-up activities require the same attention to detail and focus as the rest of the trial. Early planning efforts during this early stage pay off later during the trial maintenance phase. Key elements to a successful start include understanding regulatory requirements, defining trial goals, and ensuring that the data collected and analysis process are aligned with those goals.
  • Design
  • Clinical trial design and consultation
  • Blinded independent central review (BICR) design
  • Image acquisition and protocol development
  • Database and application design, development and validation
  • Imaging Charter development
  • Qualification
  • Site qualification and technical evaluation
  • Test image transfer
  • Site training and initiation
  • Standard image acquisition protocol development and training
Imaging services for clinical trials

Trial Maintenance Phase

Expert subspecialty review, reader training and testing, and strict quality control (QC) of collected images come together under WCC’s total project management expertise. Our focus on regulatory preparation means all trial maintenance activities are performed within a proven workflow ensuring exceptional quality, consistency and regulatory compliance.

The quality of the evaluation results depends on strict and sophisticated expert reviewer training and continued variability monitoring to ensure performance. Our in-depth reader training, testing and ongoing performance monitoring are designed within this framework to maximize precision and accuracy.

  • Activities
  • Image collection and QC
  • Query resolution
  • Imaging eCRF (smart forms) design and development
  • Independent radiology review
  • Expert reporting of read results
  • Trial-specific newsletters and other regular communication
  • Management
  • Operational expertise and trial workflow development
  • Quality Assurance and regulatory control
  • Project tracking
  • Real-time trial status reports
  • Digital image conversion
  • Technology support and maintenance
  • Reader Performance
  • Reader training and testing
  • Inter- and intra- reader variability
  • Performance monitoring
  • Selective performance testing
  • Regulatory
  • Regulatory consulting

Focus on 3D Imaging

With unparalleled radiology excellence and a strong emphasis on imaging study quantification, WCC works consistently to develop and improve imaging analysis solutions to increase the precision and accuracy of imaging interpretation. Our utilization of 3D modalities is a critical part of our drive to refine the science of imaging. With an increased focus on 3D analysis for early-stage oncology and CNS studies in particular, WCC is providing sponsors with critical imaging data with improved precision for a variety of therapeutic indications.
Unparalleled radiology excellence
Imaging for clinical trials

Advanced Understanding of Imaging Science and Regulatory Requirements for Imaging

With a cutting-edge focus on 3D imaging and the aim to improve reader precision in recognizing signs of efficacy as early as possible, WCC is developing software and image reading paradigms to further hone its scientific approach to imaging and deliver best-in-class radiology reviews to sponsors. Regulatory requirements for how imaging studies should be conducted are promulgated by the Division of Medical Imaging Products (DMIP). WCC has a long history of representing sponsors in meetings with the DMIP and has recently written two review article covering the new FDA guidelines on use of imaging.

Closeout

At study closeout, WCC provides full regulatory consulting and assistance accompanied by image archival services that allow for central review or simple post-trial storage. This ensures all data is stored safely and securely for FDA submission, whether directly following your trial or any time in the future. Regardless of your trial needs, we enable you to maintain control throughout the entire process.
  • Regulatory
  • Preparation and submission of documentation for regulatory submissions
  • FDA submission assistance, including support at regulatory meetings
  • Mock audits of trial data
  • Archive
  • Off-line image archive
  • Indexed eCRF repository
  • In-house long term archiving (optional)

To benefit from our Imaging Expertise

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