The new platform, Addplan neo, combines modules from pre-existing technology and puts them all under one umbrella.
According to the contract research organization (CRO), the new platform accelerates simulation and can compute multiple projects on one framework.
A spokesperson from Icon told us, “The release of Addplan neo demonstrates Icon’s continued focus on innovative approaches across all stages of clinical development, with the focus on adaptive and Bayesian designs.”
To make this software run simulations more efficiently, the program was recoded. “The C program code was rewritten to speed up the Monte Carlo simulations within the software,” said a spokesperson. When approaching an adaptive clinical trial running probability simulations like that of a Monte Carlo can often be imperative for trial recruitment.
The company continued by saying that the new modulation formulation will allow clients to use the same system for years to come.
By unifying the technology into one platform there should be a stronger user experience due to an updated graphic user interface (GUI), making the software easier and faster to use, according to the company.
In August of 2018, the FDA launched a new pilot program for innovative clinical trial designs as part of a commitment under the Prescription Drug User Free Act (PDUFA) VI which makes speed critical for Icon.
Per the FDA, the innovative trial designs include: seamless trial designs, modeling and simulations to assess trial operating characteristics, the use of biomarker enriched populations, complex adaptive designs, Bayesian models and other benefit-risk determinations.
In the PDUFA Commitment Letter, “the improved speed becomes a major factor in an expeditious comparison of plausible design options and finding better alternatives.”
