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Glossary



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.

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