Comprehensive Protocols Customized to Your Trial
When planning your clinical trial, we will develop a study-specific Image Review Charter (IRC) as an adjunct to your clinical investigational plan (CIP). The IRC documents the relevant imaging modalities, assessments, and methods used to assess the effect of your treatment. Targeted to the unique requirements of your trial, we develop each IRC based on the literature and clinical guidance of our experts.
The following information is included at a minimum:
- Imaging objectives and endpoints.
- Modalities and acquisition techniques.
- Site qualification and training plan.
- Image labeling and transfer procedures.
- Requirements and credentials of the image reviewer(s).
- Image analysis scope and methods.
- Process and criteria for quality control and assurance.
- Requirements for data blinding, locking, and reporting.
- Mechanisms for data storage, management, and archiving.
Our IRCs are designed for review by regulatory authorities, IRBs, ethics committees, investigators, and others. They have a successful history of review and approval and are developed in accordance with published guidance. In 2018, the US FDA released new guidance on imaging process standards upon which our IRCs are based.
Expert Guidance on Endpoint Selection
Based on our experience and knowledge of the literature, we provide informed guidance on the proposed imaging endpoints for your trial. We recommend appropriate success criteria for each endpoint and provide literature-based justifications of the proposed imaging plan and assessments. As appropriate, we maintain proactive communication with your clinical staff and advisors to assure alignment of our recommendations with your study requirements and objectives.