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Since our inception in 1992, we have had experience performing imaging studies in all therapeutic areas as well as in device trials and imaging agent development. Through our ongoing and unique relationship with the Massachusetts General Hospital (MGH) Department of Radiology, we have the ability to access leading researchers in all areas of imaging. Over the last 10 years, we have expanded our services outside of imaging to provide assessments of overall patient status in multiple therapeutic areas, including cardiology, neurology, oncology, and dermatology.


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Trial Management

Imaging services are the core of our business:

  • Twenty-year history with large international Phase 3 trials
  • Ten-year endpoint assessment experience
  • Experienced project managers
  • Successful regulatory agency inspection history
  • Extensive experience managing all aspects of trials utilizing imaging endpoints

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Therapeutic

We can provide expertise in the assessment of any subjective clinical assessment:

  • We have worked in all areas of imaging analysis with all common modalities
  • Extensive oncology experience
  • Strategic relationship with MGH
  • Proven training and testing paradigms
  • Advanced WorldPRO platform

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Reader Training

When it comes to reader review and data management, precision and control are of the utmost importance. Our scientific approach to imaging provides sponsors with the most accurate and reproducible datasets available. We provide access to operational metrics and clinical statistics every step of the way to improve the accuracy of the trial. Our advanced understanding of diagnostic statistics and variability testing metrics allow WCC to provide an unparalleled depth of understanding of trial data.

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Blinded Independent Central Review

For registration trials with subjective endpoints, a regulatory agency may require a blinded independent central review (BICR) of the trial data. We provide reviews by subspecialty-trained, board-certified experts, who are trained under a uniform system to maximize the precision and accuracy of data interpretation.

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Read Teams

Led by imaging scientists, engineers, clinical developers, and regulatory experts with extensive experience, WCC has a dedicated team that serves as an extension of your team to ensure unmatched expediency from start to finish. Our own proven, in-house radiology expertise is complemented by experts from the world’s most renowned medical institutions.

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Regulatory

WCC has successfully managed the reads of clinical trial data for FDA-approved drugs in a number of therapeutic indications.

  • WCC is an industry leader in understanding regulatory requirements for imaging studies
  • Experience presenting to the FDA, EMEA, and Advisory Panels
  • Designed and defended Phase 1-3 trial design, including special protocol assessments
  • Negotiated Phase 1-3 trial designs with the FDA
  • Successful audit history including EAC trials
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Global Reach

Utilizing the features of our WorldPRO® platform to support readers remotely, we provide round-the-clock technical support to sites in global clinical trials and have worked with a plethora of imaging formats. Sponsors have the freedom to work with the best talent around the world knowing our training, data management, and reads are globally consistent at no extra cost.

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