FLEX ADVANTAGE empowers you to proactively manage key aspects of your clinical trial including randomisation, clinical supplies inventory management, complex patient dosing, and regulatory and safety unblinding.

• Increased configurability - more configuration options with the ability to customise to your specific study requirements
• Shorter build timelines - enabling you to get your study up and running quicker
• Easy to use system - reducing burden for site staff
• Self-serve options - enabling you to take control and manage processes including randomization, drug management and device distribution
• Printable patient audit logs - sites and monitors can print patient transaction history, inclusive of data changes directly from the system
• Clinical supply management tools - updating pack status, expiry information, batch release, manual shipments and many more - tools that allow faster decision making and execution
• Flexible system generated notifications for real time trial information
• Dynamic visit data collection - intuitive data collection allowing for reduced system development time and data entry errors 

Accessible via the web and web-enabled mobile devices, it is a configurable framework containing a library of reusable system modules, which are always ready for your trial’s needs. While these components can be implemented without any additional programming, the platform also has the flexibility to allow for modules to be fully customised as per a given study’s requirements.

Benefits:

• Mid study modification of randomisation modules
• Adaptive design enabled
• Comprehensive Inventory Management utilities available to Sponsors/Clinical Supply Managers
• Allows a study to start with a minimum of packaged drug
• Global technical help desk available 24/7
• Interface for statisticians to configure and review the randomisation for all types of trials including adaptive studies

Features include:

• Configurable framework for modules and reports also allows for customisation per study needs
• Extra authentication level to access blinded information (e.g. of randomisation & drug kit numbers within study database)
• Permission and role based with customisable warning messages, alerts, and reminders
• Self-service utilities including, but not limited to; inventory tracking, batch management, and kit assessment
• Efficient and automated supply management, including but not limited to; inventory tracking, batch management, and kit assessment
• Reporting dashboard providing clients, investigators, and clinical supply teams with a real-time view of their study
• Web reporting - standard and customisable reports with ad hoc reporting capability
• Seamless integration capabilities with leading EDC, CTMS, laboratory, drug distribution and other vendors
• Supports adaptive trials, adaptive randomisation schemas, and other complex drug supply algorithms
• eConsent capabilities via integration with FIRECREST

Reporting Dashboard

The FLEX ADVANTAGE reporting dashboard is a user-friendly system which helps clinicians and supplies professionals to maximise the value of their clinical data. Through the use of standard and custom reports, clients can view alerts, trial metrics, key performance indicators (KPIs) and other trial related information at a glance.

The interface enables clients to easily interact with their data, and to view, drill down, sort, filter, analyse, and share information with team members. Users can quickly create graphs, charts, and tables. The system’s ad-hoc reporting capabilities allow clients to create custom reports in minutes.

Clinical Supply Management

Sometimes errors in clinical supply management can have critical and costly consequences for a clinical trial. In trials with drug shortages or high manufacturing costs, ICON’s FLEX ADVANTAGE IWR platform helps to lower trial costs through its drug inventory management capabilities.

Our system allocates drugs on an as needed basis, keeping sites stocked with only the amount they need based on patient enrolment. Investigational product can be shipped as needed, and our systems allow for global tracking and monitoring of supplies, enabling clients to always know where inventory levels stand.

Inventory Management for Adaptive Trials

FLEX ADVANTAGE takes inventory control to the next level. In an adaptive trial with dynamic randomisation, inventory control needs to be accessible at all times. The system must know precisely what kits are on site and available for deployment.

FLEX ADVANTAGE has streamlined all of this by creating an environment specifically for the product supply team which constitutes an interactive logistics, supply chain, and inventory control management system. It allows depot to depot exchange, supply packing, shipping to sites, and a quarantine / stability interface with clinical supply and site.

Help Desk Support

The ICON Help Desk supporting FLEX ADVANTAGE assists more than 4,000 users each month. This Helpdesk is available 24 hours/day, 7 days/week. Users access the Helpdesk toll free using an AT&T Access code or designated toll free number. In addition, the Helpdesk can be contacted via email.

Each Help Desk Agent receives individualised training to ensure an understanding of the technical aspects of your protocol. Calls are monitored to ensure we are providing the highest quality service. A custom call ticketing system allows for retrieval and tracking of call information.