WorldCare Clinical - Imaging Study Services for Blinded Imaging Trials

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Study Start-Up Services

An imaging CRO’s expertise in trial design and acquisition protocols can be instrumental in reducing a study’s size, duration, and overall cost.

From the first steps of study design through total Imaging Charter development, WorldCare Clinical conducts all imaging trial start-up activities with the same attention to detail and focus on data control that characterizes the entire study. Study design, protocol development, and full site qualification and training ensure a smooth set-up and streamlined planning for seamless movement to complete trial execution and maintenance.

Trial Design

Clinical study design and consultation
Blinded Independent Central Review (BICR) design
Imaging protocol development
Imaging Charter development

Site Start-up

Site qualification and technical evaluation
Test Image transfer
Site training and initiation
Standard Image Acquisition Protocol development and training

Trial Document Design and Development
WCC’s extensive experience with trial charters and study-specific documentation is a critical asset in designing for regulatory success. Efforts to control variability in procedure and performance depend on uniform training and documentation, as well as a tried-and-true approach to development. Specific document expertise includes:

Imaging and other independent review (e.g., dermatology, pathology, etc.), Charters
Endpoint Assessment Committee Charter
Imaging and other technical user manuals and study-specific forms

In response to increasing requests from sponsors for independent review of radiology, pathology, dermatology or clinical information, WCC now offers eligibility review services designed to evaluate eligibility data and confirm inclusion of appropriate subjects to help sponsors mitigate the risk of enrolling the wrong patients. Eligibility confirmation is especially important when conducting a clinical trial in a complex disease, such as melanoma. Using WCC’s eligibility review services, sponsors ensure that sites enroll the right patients so that interpretations are consistent with other participating sites, leading to more successful outcomes.

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WorldCare Clinical’s commitment to total trial management is framed by a scientific approach to imaging and supported by the WorldPro technology platform that automates quality control measures for a streamlined project workflow.

WCC knows valid image review depends on strict and sophisticated reader training and continued variability monitoring to ensure performance, and all study maintenance activities are designed within this framework for data control and regulatory preparation.

Study Activities

Image Acquisition Protocol development
Image collection and QC
Query resolution
Imaging eCRF (smartforms) design and development
Independent radiology review
Expert reporting of read results
Trial-specific newsletters and other regular communication

Reader Performance Prep & Monitoring

Reader training and testing
Inter-and intra- reader variability
Performance monitoring
Selective performance testing

Project Management

Operational expertise and trial workflow development
Quality Assurance and regulatory control
Database design
Project tracking
Real-time study status reports
Digital image conversion
Technology support and maintenance

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WorldCare Clinical conducts all trials with an eye toward successful regulatory submission and approval, and study closeout services are designed to make this process as easy as possible for the sponsor.

Full regulatory consulting and assistance are accompanied by image archival services that allow for central review or simple post-study storage to ensure all data is stored safely and securely for FDA submission – whether directly following your trial, or any time in the future. No matter how we coordinate your trial’s end, you maintain control to the finish.

Regulatory

Regulatory consulting
Preparation and submission of documentation for regulatory submissions
FDA submission assistance, including support at regulatory meetings
Mock audits of trial data

Image Archival

Active and post-study storage
Image library
Collect, Ready, Hold

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WorldCare Clinical’s Imaging Trial Expertise Extends Beyond Your Radiology Review

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:

WorldCare Clinical is an exceptional imaging CRO that focuses on providing independent, blinded diagnostic evaluation of disease. WCC delivers regulatory-compliant data to sponsors all over the world by bringing together an unparalleled fusion of radiological excellence, therapeutic expertise, a best-in-class technology platform, and a commitment to advancing the science of imaging and independent diagnostic evaluation – all within a highly sophisticated approach to biostatistics and trial workflow. Working as an extension of your clinical team, we can guide you through any part of the process, whether it is management of an entire imaging trial from start to finish, or by providing specific services such as independent pathology review, endpoint assessment committee, or imaging charter development for a highly specific study. Details about our complete services can be accessed below:

Study Start-up

From initial trial design and imaging protocol development to site qualification and training, WCC conducts all study startup activities in a framework designed to ensure data validity and control from the very outset. With our extensive experience we design image acquisition protocols for all modalities.

Study Maintenance

Expert subspecialty radiology review, reader training and testing, and all other QC measures come together under WCC’s total project management expertise. Our focus on regulatory preparation means all study maintenance activities are executed within a strict and proven workflow for maximum control.

Study Closeout

WCC's regulatory consulting services, which include mock audits, data preparation and submission, and assistance at agency meetings, are complemented by an extensive range of options for storage, archival, and even retroactive FDA review.

Special Services

Additional services for customized needs include our Collect, Ready, Hold capability, Endpoint Assessment Committee, digital pathology reading services, skin lesion quantification and reading services, and imaging method development to provide state-of-the-art technologies.