Clinical trial protocols are becoming more complex as clients seek to achieve multiple objectives with a single protocol

The management of clinical supplies continues to be a cause for budget creep and potential timeline delay.  This along with the demand for near real-time critical data to support study decision making has meant that clinical teams require an effective way to manage these challenges.

Our Interactive Response Technology (IRT) services effectively manage patient enrolment, randomisation, dosing, clinical supplies, data integrations, drug returns and drug reconciliation. We provide innovative solutions to support you in the proactive management of sites, patients, and clinical supplies and specialise in the design, development, validation, and management of Interactive Web Response Systems (IWRS) for Phase I-IV clinical trials.

ICON now offers you a choice of IRT technologies, our proprietary RTSM FLEX ADVANTAGE and Medidata Rave RTSM, a cloud-based solution.

  • 1,800+

    Studies implemented worldwide
  • 28

    Therapeutic areas
  • 50,000

    Sites in 85 counties

Flexible innovative solutions

FLEX ADVANTAGE

Our IRT platform FLEX ADVANTAGE offers enhanced randomisation and clinical supply management capabilities. It empowers study teams with a full complement of real time web reports available via a customisable dashboard. Its ad hoc reporting capability enables users to easily create custom reports and drill down functionality for better interaction and analysis of study data.

FLEX ADVANTAGE can be integrated with ICON technology solutions such as ADDPLAN, FIRECREST, ICONIK, Medical Imaging 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.   

Robust System Development Life Cycle (SDLC)

Our SDLC has successfully passed regulatory, sponsor, and internal audits. Control points during each phase coupled with compliance and QA reviews ensure the delivery of a quality system.

Medidata Rave RTSM

The Medidata solution is 100% configurable, unified with Rave EDC and is offered on the Medidata Clinical Cloud®.  Rave RTSM reduces risk and increases data quality with single source of data and the unified platform approach. It is user friendly, flexible and able to support mid-protocol changes with its Edit Live DesignTM.

 

Trial management and support

You will be appointed a dedicated project manager who will be your main point of contact for the lifetime of your study. They will identify the optimal solution and governance models to meet the protocol and your stakeholder objectives. Our project managers have a minimum of 6 years experience.

Services include:

  • Clinical supplies management – automated site and depot medication inventory control, including expiry date management and drug recall

  • Data Integrations with ePRO, EDC, drug distribution and forecasting vendors as well as other ICON services to assist with speedy data analysis
     
  • Full adaptive trial support
     
  • Patient centric services

    Management of patient enrolment to prevent over recruitment
    Randomisation and treatment schemes to assign the right treatment at the right time to the right patient
    Manage assignment of treatments and complex dose titrations to patients

A Help Desk service is available 24 hours a day, 7 days a week via email or phone, staffed by ICON employees. It supports over 180 languages, and more than 90% of calls are addressed on the first call.  All calls are logged and tracked providing you with peace of mind in service levels.

Clinical trial and systems expertise

We have over 20 years of experience in the IRT industry managing studies, ranging from small to large, complex, multinational projects.

Our study teams have a vast understanding of the technical and clinical elements of an IRT system. This equips them to focus on defining, building and managing a solution that will effectively support your protocol and trial requirements.