Regulatory

WorldCare Clinical (WCC) has a proven track record of successfully managing and submitting clinical trial imaging studies to regulatory bodies such as the FDA. We've managed clinical trial imaging for FDA-approved drugs in a number of therapeutic indications.

We work closely with sponsors to determine the most effective way to meet agency requirements, harmonizing the imaging process to maximize FDA optimization. Our services encompass all regulatory aspects of clinical trial design and execution, including:

Imaging charter development (WCC has extensive experience in CHESON and RECIST criteria in particular)
Submission of imaging data for audit and approval
Support at meetings with regulatory agencies
Audits of study-specific images
Preparation and submission of documentation for regulatory submissions
Response to regulatory questions about image analysis
Production of electronic data sets for case report tabulations
Production of reports that meet regulatory electronic submission requirements
Logging and tracking of correspondence with regulatory agencies

For more information on these and other services please email us at info@wcclinical.com or call us at 1 (888) 816-4721.

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Regulatory Successes

Here are just a few examples of therapeutic treatments that we have successfully seen through the regulatory process:

Abraxane. American Bioscience, Inc. relied on WCC to manage the review of CT scans, radiographs, and bone scintigrams with MGH radiologists. WCC developed WorldCare Remote Imagine Solution (WRIS), an innovative process that provided the FDA with secure remote image review.

Xeloda. For this Phase II trial by Hoffman LaRoche, WCC provided image management, over-reads, and digital measurement of chest and abdominal lesions in patients diagnosed with metastatic breast cancer. This included more than 2,500 CT, ultrasound, MRI, and X-ray images, and more than 800 measurements recorded and quantitatively analyzed in a standardized manner.