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