Designed to collect and store images in a single, secure database prior to radiological assessment, WCC provides sponsors with a cost-effective solution to proactively plan for a central review and optimize the regulatory submission process by decreasing the time and cost associated with retrospective image collection.
Collect: WCC executes all study startup and maintenance services, including image acquisition protocol development, site identification and qualification, training on the required imaging technique, and standardization of the image collection process.
Ready: WCC performs administrative and technical QC of the images submitted from investigator sites and resolves any issues identified.
Hold: Instead of transitioning directly to closeout procedures designed for regulatory preparation and review, WCC holds the images in a database until it is determined if a central review of the imaging data is required.
How Collect, Ready, Hold Can Help Your Trial
As part of our industry-leading WorldPRO® image management system, Collect, Ready, Hold uses a validated and compliant module to store imaging data in a single database, which helps to streamline review processes and save time required for retrospective image collection. It proactively reduces time and site management costs if a central review or independent panel access is requested at a later date.
The service is designed to maximize cost-effectiveness over the entire duration of the trial, so sponsors pay only a small transaction fee for each image uploaded. Storage is free for the first two years, but WCC will archive your images for as long as you need for a nominal annual fee.
And because our WorldPRO technology is modular and easily configurable, developing eCRFs for central review is quick and simple – which means you get your team up and running as fast as possible. The system is also fully compatible with other reading platforms, which gives our sponsors maximum flexibility to work with any CRO or radiology review team of their choice.
WCC focuses on providing Blinded Independent Central Review (BICR) services in studies that often require sub-specialty endpoint assessments. To meet sponsor’s needs, WCC offers Cardiovascular Endpoint Committee (CEC) services to evaluate adverse events (AEs) using safety coding dictionaries including MedDRA. Leveraging our 20-year strategic relationship with Massachusetts General Hospital, WCC’s solution provides access to leading experts in cardiology and neurology to complete the safety reviews.
WCC designed its Cardiovascular Endpoint Committee solution in conjunction with sponsors to comply with the FDA and other regulatory agencies’ requirements for independent verification of safety events. This solution offers an adaptable service that resonates across multiple therapeutic areas.
WCC’s solution:
WorldPRO® : A Flexible Solution for BICR
WCC’s proprietary digital portal WorldPRO® provides Sponsors:
Contact us today to find out more.
In response to the growing emphasis that regulatory agencies are placing on safety reviews, WCC provides safety assessments in a timely fashion using our in-house, cohesive team of practicing, board-certified, sub-specialty trained radiologists. Reading teams are identified based on extensive experience relevant to the disease population being studied.
Since your safety or incidental finding assessments are time-critical, WCC provides reviews within 24 hours of receiving scans, seven days a week and can deliver emergency reads even faster, if required. Efficacy assessments in imaging studies are often facilitated by a batch review, resulting in extended delays in determining incidental safety findings. WorldCare Clinical (WCC) understands the need to address these concerns quickly and efficiently. Using our proven WorldPro technology platform and working with our affiliate ProScan Reading Services (PRS), a leading provider of large-volume teleradiology services accredited by the American College of Radiology, we offer an integrated reading service that provides comprehensive safety assessments, promptly and accurately.
Empowering Rapid Turnaround of Safety Data: WorldPRO®
WCC’s WorldPRO image management platform is a comprehensive system that collects, anonymizes, integrates, and presents imaging data to multiple reviewers in a regulatory compliant, efficient and effective manner. WorldPRO includes the following key functions:
Read more about our WorldPro platform here.
WCC’s end-to-end imaging services for clinical trials encompass a full range of capabilities that allow us to support your study over its many phases. In addition to full start-up, radiology review and regulatory assistance, WCC’s special services include management beyond imaging with Endpoint Assessment Committee review and image archival offerings like Collect, Ready, Hold. Read more about our additional, customized services below:
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