We have an extensive history in preparing submissions for regulatory approval by the U.S. Food and Drug Administration (FDA) Medical Imaging Division, the European Medicines Agency (EMEA), and the Medicines and Healthcare Products Regulatory Agency (MHRA), and maintain ongoing relationships with these agencies to ensure we keep you up to date with the latest regulatory requirements and audit processes. We recently published multiple review articles on regulatory requirements for conducting imaging studies.
Imaging Charter Development
Prepared by your trial's project manager, lead radiologist and independent assessment panel, imaging charters are documented to cover requirements for image submissions, anonymizing data (as required), quality assessments, independent review, and response criteria to support the imaging protocol.
WCC's team has experience hosting and supporting inspections conducted by regulatory agencies throughout the world (including FDA, EMA and MHRA). Our Quality Assurance and Regulatory Affairs (QA/RA) team works with you to ensure success in meeting a regulatory requests and/or on-site inspection requirements.
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. WCC can provide in-depth imaging experience when participating in special protocol assessment (SPA) meetings with the FDA.
We produce imaging data reports that meet regulatory electronic submission requirements and can provide access to FDA and other regulatory agencies for easy review of submitted images.
Quality Control and Regulatory Compliance
Our streamlined quality control process integrates critical data management and statistical analysis components throughout the trial. We deliver complete transparency by giving sponsors the ability to confirm that all data has been properly handled before final assessment, helping protect against multiple re-reads that will negatively impact FDA approval. We ensure that results can be effectively used for regulatory submission and provide extensive digital audit trails every step of the way.
Quality Management System
WCC's Quality Management System (QMS) has been designed to provide the structure and controls required to support the clinical study execution and ensure that our processes meet industry standards. Our QMS includes technical and procedural controls that reflect ICH Q10 and GxP industry standards.
We regularly perform internal audits to ensure study data quality and compliance to WCC's Quality Systems requirements and industry regulations. In an effort to fully prepare for regulatory review, we have the ability to run mock regulatory inspections as well as participate in any sponsor-run mock inspections.