WorldCare Clinical has successfully managed imaging studies for FDA-approved drugs in a number of therapeutic indications.

Our approach to trial control and commitment to data accuracy are the foundation for regulatory services that frame the entire study from initial design and statistical plan to project management. We conduct every trial with the goal of maximizing the potential for successful regulatory submission, and we work closely with sponsors to determine the most effective way to meet agency requirements with services that encompass all regulatory aspects of trial design, execution, and compliance.

Specific regulatory services include:

• Imaging charter development (WCC has extensive experience with RECIST 1.0, RECIST 1.1 and CHESON criteria in particular)
• Consulting services and support at SPA meetings with regulatory agencies
• Routine mock audits of trial data in preparation for regulatory review
• FDA audit hosting
• 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

Agency Experience: Positioned for Success

WCC brings a specialized level of imaging expertise to sponsor trials, thanks to an extensive history with the FDA’s Medical Imaging Division and the EMEA. Currently participating in SPA meetings with the FDA, we also offer unique auditing experience after incorporating agency feedback to enhance audit trails for EAC review. In addition to implementing a new audit trail for all EACs participating in our trials, our staff has direct experience working with inspectors from the FDA, MHRA, and EMEA, and is a strong partner for advising sponsors on a well-informed approach to regulatory review.