Interactive Response Technologies

Transcription

1 Interactive Response Technologies

2 Increasing accuracy and efficiency in clinical trials To increase the accuracy and efficiency of conducting your global clinical trials, ICON s Interactive Response Technologies (IRT) group develops, implements, and manages an industry leading technology platform comprised of interactive voice and web response systems (IVRS and IWRS) combined with cutting edge web technology. Our team of experts works closely with each client in order to recommend the right solution to meet their specific study needs. Our turn-key solutions are designed to comply with 21 CFR Part 11 requirements and are in use with hundreds of global, multilingual clinical trials. Gathering input from biotech, pharmaceutical and medical device organizations across the world, ICON has developed the following services to meet the requirements of your clinical trial: - Electronic Patient Reported Outcomes (epro, ediary) - Patient Enrollment and Randomization - Visit Tracking and Patient Management - Medication and Device Inventory Management - Data and Platform Integration Capabilities Our team of experts works closely with each client in order to recommend the right solution to meet their specific study needs. Randomization One of the most important elements of a well-run clinical trial is the integrity of the randomization. With Our extensive experience with many different types of randomization schemes, such as dynamic balancing, multiple stratification criteria and dose titration calculations; have enabled ICON to develop comprehensive solutions to meet your trial design needs. With ICON s IRT platform you are able to automate and simplify the implementation of any complex randomization scheme. 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 IRT 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 you to always know where your inventory levels stand. 03

3 epro ICON s IRT epro component provides your study with real-time access to more accurate and reliable patient data-. It reduces the typical implementation time of traditional IVR/IWR systems, enabling studies to reach critical milestones quicker and regulatory submissions to be submitted sooner. In addition, increased patient compliance improves the validity of study data, providing more concrete scientific results for clinical studies. The IRT platform provides a reporting application that allows you to securely access realtime web-based reports on your schedule, 24 hours a day. PRO Consulting ICON s Interactive Response Technologies team has extensive experience in both the design and implementation of Patient Reported Outcomes (PRO) research through ICON s Lifecycle Sciences group. This combination of scientific expertise from Lifecycle Sciences group and the sound IRT technology and experience of the Interactive Technologies group, allows ICON to offer turnkey PRO services that support client research endeavours and achieve crucial study milestones. Reports The IRT platform provides a reporting application that allows you to securely access real-time web-based reports on your schedule, 24 hours a day. A comprehensive suite of standard reports is included as well as the capability to build custom reports as required. You have the option of exporting directly into a variety of formats or use the built-in filtering capability. Common reports include; Patient Enrollment, Randomization, Drug Inventory & Shipping and Patient Visit Progress. 05

4 Seamless System Integration To enable our sponsors to capture data entry and cost efficiencies, ICON IRT platform has the ability to integrate with a variety of clinical trial applications, including CTMS, EDC systems, Lab systems and Inventory Management systems. Any information collected with the ICON IRT platform can be transferred to adjacent systems. We help streamline your clinical trial process by integrating our IRT platform with many of the most common applications used today. Help Desk You want help when you need it, and not by contractors that may or may not know the system. The IRT Help Desk is available 24 hours per day, 7 days a week via or toll-free phone access, and is staffed by ICON employees. We support over 140 languages, and more than 90% of all calls are handled on the first call. Inquiries are reviewed on a monthly basis and monitored randomly to measure quality and determine any trends or common issues. Experience As pioneers of IVR, IWR, and epro technology, ICON has a proven track record of using technology to help our clients manage their clinical studies. We have the experience and the expertise to help you build yours. We have built a solid foundation in all aspects of electronic trial management solutions Completed over 850 implementations worldwide, Our systems have managed over 50,000 sites More than 25,000,000 patient transactions Supported over 65 languages in more than 85 countries Built to High Standards Validation To ensure that quality is built into each step of the process, your IRT platform solution follows our standard System Delivery Life Cycle (SDLC), which governs the way we build our systems to the highest standards. Each system is fully validated, and the IRT platform is 21 CFR Part 11 compliant. Reliability You rightfully expect that your data is always protected and safe, and that there is no unexpected system downtime. To provide you this security, ICON built a high level of redundancy for the IRT platform. It is designed to automatically fail-over to a separate secondary location in the event of a disaster, keeping your data secure. Excellence in Delivery ICON s Interactive Response Technologies team not only have the expertise to work with you to produce IVR/IWR systems that meet your study team s specifications, but they see the overall picture and are dedicated to helping to achieve your research goals. ICON s IRT team has a proven record of developing and implementing validated IVR/IWR and other technology systems with high quality, on-time delivery since inception. Our project management is underpinned by comprehensive and consistent processes which conform to ISO9001:200 and our project managers have an average of more than five years of experience. 07

5 About ICON ICON is a global provider of outsourced development services and technology to the pharmaceutical, biotechnology and medical device industries. We specialise in the strategic development, management and analysis of programs that support Clinical Development - from compound selection to Phase I-IV clinical studies, ranging from small studies to complex, multinational projects. ICON plc U.S EU [email protected]