- Leadership
- Global Reach

Regulatory

WorldCare Clinical has successfully managed imaging studies 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 by offering services that encompass all regulatory aspects of clinical trial design and execution, and a regulatory team with extensive imaging trial experience. Our services include:

Imaging charter development (WCC has extensive experience with CHESON and RECIST criteria)
Consulting services and support at meetings with regulatory agencies
Routine mock audits of trial data in preparation for regulatory review
Preparation and submission of documentation for regulatory submissions (WCC has experience with submission to FDA, MHRA, and EMEA)
Production of reports that meet regulatory electronic submission requirements
Provide access to FDA and other regulatory agencies for easy review of images provided for submission

Spotlight on WCC Regulatory Approvals

Regulatory Resources for Download

FDA Form 1571

FDA Form 1572

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

< Back

Regulatory Successes: A Closer Look

Here are just a few more detailed examples of therapeutic treatments 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 utilized WorldCare Remote Imaging 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.