Late Phase Development

Established track record in delivering neuroimaging and digital biomarker solutions in global, multi-site clinical trials

Capacity

Track record in qualifying over 2000 imaging centres across 75 countries globally, ensures fast imaging site activation for trial readiness.

Imaging Operations

Secure data

Compliant data management environment for receipt, assessment, and analysis, ensuring data standardisation and regulatory compliance.

TrialTracker

Patient stratification

Patient recruitment at scale can be difficult. At IXICO we use leading data analytics and AI techniques to facilitate patient enrichment and stratification.

Analytics and AI

IXICO have a great operations team - nimble, responsive, knowledgable and very easy to work with. IXICO were clearly on top of the work, and very quick to find solutions.

Enrichment Strategies

Fast and selective recruitment will drive down study duration and costs

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.

Regulatory Considerations

Ensure clinical protocol design can support regultory submissions

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.

Imaging Site Selection

Selection, standardisation, and setup of imaging sites can be a challenge

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.

Data Compliance

Late phase trials generate large volumes of data which must be stored compliantly

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.