Late Phase Development

In late phase clinical development, it is important for the trial design to consider the use of novel enrichment strategies, such as the use of novel imaging biomarkers, to aid patient selection/stratification and therefore enrich the patient population. 

This will drive down recruitment requirements, and therefore costs, but also add power to your statistics.

In late phase trials, it is essential to develop the image review charter in a way that any exploratory endpoints in the trial could be used to support regulatory submissions. For example, looking at ways to elevate an exploratory imaging marker to be a secondary endpoint. IXICO can provide expert scientific input into the imaging design, and align with discussions with the regulators.

Selecting the correct clinical and imaging sites for a late phase global trial can be a challenge. IXICO has an extensive global network of imaging centres and can support the appropriate selection of sites, ensuring the correct equipment and experience at the sites for the protocol requirement. Using a pre-qualified network of sites can reduce the study setup time and overall on-boarding of sites.

Image files require transfer, storage and processing systems that can handle the size and volume of data received in late phase trials.  IXICO's TrialTracker platform delivers a robust and comprehensive set of centralised imaging services designed to efficiently manage the complex imaging workflow from receipt, assessment, and analysis, ensuring data standardisation and regulatory compliance.