Icon launches technology for adaptive clinical trial design

By Maggie Lynch contact

- Last updated on GMT

(Image: Getty/scyther5)
(Image: Getty/scyther5)

Related tags: Clinical trial, Clinical trial management, CRO, Technology, Fda, Simulation, Adaptive trials, Software

Icon has launched an integrated technology platform for the design, simulation, and analysis of adaptive clinical trials.

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.”

Related news

Show more

Related products

show more

Manufacturing Cyto and Non-Cyto Drugs in One Facility

Manufacturing Cyto and Non-Cyto Drugs in One Facility

Baxter BioPharma Solutions | 05-Nov-2018 | Technical / White Paper

Recent market reports suggest increasing product niches, which may lead to decreasing numbers of units per product, making dedicated facilities less practical....

Baxter’s Oncology Contract Manufacturing

Baxter’s Oncology Contract Manufacturing

Baxter BioPharma Solutions | 29-Aug-2018 | Product Brochure

Baxter BioPharma Solutions’ FOYA award-winning facility in Halle/Westfalen, Germany, offers state-of-the-art parenteral cGMP manufacturing at one location,...

Related suppliers

Follow us


View more