Clinical Trials Imaging Consulting

The need to understand the benefits and pitfalls of using medical imaging as a surrogate endpoint in clinical trials. The operational aspects of Blinded Independent Central Review. The application of Response Criteria used for endpoint determination in oncology and other therapeutic areas.

Medical Imaging Technology

Advances in imaging technology can be used to develop new imaging biomarkers.


Response Criteria

Understanding, applying, operationalizing and training on response criteria will have an impact on the outcome.


Reader Performance

Monitoring reader performance is essential to validating outcomes.


Medical Imaging Protocols

Rapid advances in imaging technology can result in more complicated imaging protocols. Efficient protocols that drive image quality deliver the best results.


Reading Paradigms

Reading paradigms are therapeutic area and operationally specific.

Site Qualification and Training

Training sites on imaging protocols and proving they can deliver quality images is important.


Reader Qualifications and Training

Readers should be chosen based on their qualifications and experience. Training on the protocol and response criteria is essential.


Due Diligence on Results

Capital placement in the pharmaceutical and biotechnology domain requires independent due diligence of early reported results.


Outcome Discrepancies

Inter-reader and site versus central review discrepancies exist and cause concern. Understanding and explanation of the differences to regulators is critical.