FLEX ADVANTAGE

Flex Advantage Express

Flex Advantage is a configurable and fully customisable web-based platform that provides an effective and efficient solution for managing patient data collection, enrolment, randomisation and drug supply/dosing regimens regardless of trial complexity. Fully validated and 21 CFR compliant, our system is specially built to meet the needs of each unique study. Our team of IRT experts provides rapid and intelligent solutions to sponsors to ensure timely study builds.

Flex Advantage benefits:

Superior quality

The ICON IRT Team brings more than 20 years’ experience and extensive industry knowledge to ensure the successful design and management of clinical trials. Our proven expertise ensures a rapid user requirements process and superior quality build.
Rapid and flexible study builds

ICON’s Flex Advantage platform is a configurable and fully customisable solution. With the flexibility to support simple and complex builds, IRT can build studies in as little as four weeks.
Extensive integrated solutions

Flex Advantage can integrate with any clinical trial system. Uni-directional and bi-directional integration solutions provide seamless access to clinical data from various sources, enabling you to make the best decisions quickly.
Expert support

ICON IRT provides a dedicated team from the build of your system throughout the lifecycle of the trial. The ICON IRT Helpdesk provides 24/7 end-user support and resolves more than 90% of incidents within minutes. ICON IRT is also supported by a robust ICON IT infrastructure, ensuring 99.9% uptime.

Client testimonial:

“Thanks to our Clinical Supplies Manager’s wide expertise and knowledge when setting up and optimising the drug supply for our global phase III trial, a potential shortage in the IMP supply was detected early and could be mitigated before any problem had arisen”.

Clinical Program Lead, Diamyd

Randomisation methods

Flex Advantage supports numerous randomisation methods, with easy configuration to suit the needs of each trial, including Central, Blocked, Stratified, Cohort assigned and BCM.

Patient safety

Flex Advantage enables authorised persons to perform emergency and/or safety unblinding throughout the trial and includes additional safeguards that prevent inappropriate sharing of blinded information.

Clinical supplies management

Works in tandem with Flex Advantage, or stand-alone, to leverage a suite of clinical trial supply management tools to streamline and manage inventory, distribution/dispensation, enable supply optimisation and reduce costs and wastage.

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Data visibility

A robust suite of real-time web, analytical, ad hoc and customisable reports and reporting capabilities aimed at empowering study teams to quickly analyse study data.

Bi-directional data flow

Flex Advantage provides industry leading integration technologies, allowing for seamless data flow between the IRT system and any integrated platform. This enables faster decision-making, higher data integrity and decreased reconciliation. Established and standardised integrations with vendors allow for quicker start-up times, reduced costs, faster shipping times and end-to-end visibility of patient and clinical supply data.

Self-serve

Built-in utilities allow users to take control directly within the system, including: drug supply management, expiration management, batch management, drug release, manual shipments, site activation, drug reconciliation, cohort management and end-user data changes.

Flex Advantage Express

In keeping with the changing clinical trial landscape, Flex Advantage Express offers an economical IRT solution for those trials that require little to no customisation. Flex Advantage Express offers IRT essentials such as screening, enrolment, randomisation, dispensation, emergency unblinding/reporting and notifications. Optional services may be attached to any level and these services can include UAT script writing, packlist/randomisation list generation and additional integrations.