Cassandra | Technologies

Cassandra is a powerful AI system that harnesses real world data on drugs and data obtained from the FDA and EMA post-marketing requirements (PMRs) databases. This information is used by Cassandra to predict the probability that the US Food & Drug Administration (FDA) and European Medicines Agency (EMA) will require post-marketing studies. This could be critical to the overall success of a new product.

Citeline Awards 2024

ICON was recognised for Excellence in Use of Real-World Data/Evidence at the Citeline Awards 2024, for its AI solution Cassandra.

The judges noted that “powered by real world data and evidence and AI, ICON developed an innovative and pragmatic system to help trial sponsors predict future post-marketing regulatory requirements and develop strategies to mitigate or eliminate those requirements early-on in their programs”.

Cassandra AI

Cassandra is trained using machine learning and data obtained from FDA and EMA post-marketing requirements and commitments databases.

Key benefits

Mitigate:

Being able to anticipate the demands of regulatory authorities allows us to define a mitigation strategy early in the drug development cycle, and this could be critical to the overall success of a new product.
Plan:

Ask Cassandra about any drug(s) currently in development, and its AI brain will provide an instant and reliable verdict on the probability of a PMR and the background context, providing sponsors with an invaluable planning tool.
Success:

Commercialisation teams can work with confidence on their post-marketing strategy based on genuine insight into future threats and opportunities. They can also gather enough additional long-term safety data on patients treated during the early phases of the development cycle to convince the authorities that a post-authorisation safety study is not needed.

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Applying AI to manage the risks and costs of postmarketing requirements

Our award-winning Cassandra AI system harnesses real world data on drugs and data obtained from the US FDA and EMA postmarketing requirements databases to accurately forecast whether postmarketing studies will be necessary.

Read the whitepaper