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Glossary



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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