Imaging Protocol Development

Comprehensive Protocols Customized to Your Trial

MMI develops image review charters and protocols tailored to the specific needs of your clinical trial. Our comprehensive protocols identify the relevant imaging modalities, acquisition methods, and assessments needed to reliably detect and document the effect of your treatment. Our protocols are based on the latest scientific research and clinical expertise of our thought-leaders. The following information is typically included in each protocol:

  • Imaging objectives and endpoints.
  • Modalities and acquisition methods.
  • Site qualification and training criteria.
  • Subject preparation and imaging procedures.
  • Image labeling and transfer procedures.
  • Image post-processing and analysis techniques.
  • Quality control processes and standards.
  • Data management, reporting, and archival procedures.

Our protocols are high-quality, professionally-produced documents designed for submission to regulatory agencies, IRBs, medical ethics committees, investigators, and others. Our protocols have a successful history of review and approval by regulatory bodies in the US, Europe, Asia.

Expert Guidance on Endpoint Selection

We provide informed guidance on the appropriate imaging endpoints for your study. Based on prior experience with related treatments and knowledge of the scientific literature, we recommend relevant success criteria for each endpoint.  As needed, we provide literature-based justifications to regulatory authorities in support of the proposed imaging endpoints and success criteria. We also maintain routine interaction with your clinical, regulatory, and technical staff to assure our recommendations are in full alignment with the study requirements and objectives.

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