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To be successful, a trial must be designed to withstand unexpected factors and handle them effectively. With over 20+ years of experience managing international trials, we have demonstrated the ability to produce results. WorldCare is a leader in the understanding of requirements for imaging trials and has recently published reviews on how to incorporate current FDA guidelines into imaging trials.


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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


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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


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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)