Icon releases Flex Advantage for patient randomization
Icon, a global provider of drug development solutions and services to the pharmaceutical, biotechnology and medical device industries, has launched Flex Advantage, a next-generation Interactive Response Technology (IRT) platform that offers enhanced randomization and clinical supply management capabilities and supports the execution of adaptive trials.
Flex Advantage incorporates a host of new features that meet the demands of the most complex protocols. The features include:
- A flexible randomization engine that supports adaptive trials: Flex Advantage contains a flexible randomization engine that can be adjusted mid-study or dynamically, which enables the execution of adaptive clinical trials and more traditional protocol changes. Flex Advantage supports adaptive randomization trials efficiently, while maintaining trial data integrity throughout.
- Support for a variety of randomization methods: Flex Advantage supports various randomization methods using easy to use plug-and-play modules, allowing for easy configuration to suit the needs of the trial.
- Support for emergency unblinding: Flex Advantage enables emergency unblinding during the course of a trial and includes additional safeguards that prevent inappropriate sharing of blinded information.
- Enhanced reporting capabilities: Flex Advantage empowers study teams by providing a full complement of real time web reports that are available via a customizable dashboard. The system’s ad hoc reporting capability enables users to quickly and easily create custom reports and also provides drill down functionality to enable users to interact with, and better understand, their study data.
- Seamless data integration: Flex Advantage is integrated with Icon products, such as ADDPLAN, Firecrest and ICONIK, and external EDC, drug distributor and drug supply forecasting systems, providing study teams with complete visibility of the clinical supply chain, from distributor to patients. Through integration with Firecrest, Flex Advantage enables sponsors and investigators to log into a single Icon portal to capture electronic consent from patients and automatically continue to screen patients within the IRT database.
Commenting on the announcement, Malcolm Burgess, Icon’s EVP, Interactive Technologies, said, “Many of our clients are embracing adaptive trial designs to optimize their drug development programs and these designs can require rapid changes in dosing and drug supply logistics. Flex Advantage not only offers a comprehensive, state of the art drug randomization and supply management system, it also fully supports the complex logistics involved in executing adaptive trial designs.”
Flex Advantage is a component of Icon’s ICONIK Informatics Hub which combines industry leading technologies with best practices to help clients to take time and cost from their development programs.