Leverage The Bracken Group’s experience and expertise to develop protocols with imaging that
will support efficient, effective research.
Few internal teams in biopharma have the expertise required to develop a strong protocol in which medical imaging is a key endpoint. At The Bracken Group (TBG), we do. Our subject matter experts are valuable resources for . . .
• Scientific and translational biomarker teams looking to identify appropriate imaging biomarkers.
• Clinical teams planning and developing studies.
• Operational teams working on implementation.
• Statisticians tasked with powering and SAP development.
• Designing protocols that minimize patient burdens and reduce potential dropouts.
• Identification and selection of appropriate imaging endpoints that are fit for purpose.
- Researching available endpoint options.
- Advising, based on the level of validation, which imaging biomarkers are fit for purpose.
- As necessary, proposing preliminary imaging biomarker work to avoid potential implementation, validation, or variability issues with biomarkers.
- Advising on techniques for ensuring imaging biomarkers can be implemented
robustly for multi-center trials.
Work with TBG to ensure...
- Appropriate endpoints are selected.
- Endpoints are crisply defined to precisely inform the development of powering calculations, statistical analysis plans, site surveys, and imaging review charters.
- Optimal imaging modalities are selected.
- Potential protocol amendments are minimized by . . .
- Stating basic imaging equipment and facility requirements so that PIs can assess their sites’ appropriateness for study participation based on the protocol.
- Ensuring any potential safety issues related to imaging are addressed for IRB review.
- Including language for the IRB to assess that the imaging will be done with appropriate quality (such as central review).
- Leaving the imaging details out but referencing that they will be made available in study specific documentation.
- Ensuring in advance that the endpoints are appropriate and analyzable.
- Ensuring that the protocol identifies the potential for the data to be used in other ways after appropriate de-identification.