An information platform that delivers clinical studies better, faster, safer and more cost effectively

Transcription

1 An information platform that delivers clinical studies better, faster, safer and more cost effectively Powering Process & Performance Proactively manage study start-up and execution Risk profile new sites Dynamically allocate monitoring resources where needed Monitor investigator and CRA efficiency and productivity Identify lapses in scientific rigor and protocol deviations Dynamically adapt your trial design Make immediate go/no go decisions Drive quality and performance

2 A powerful combination of business intelligence, analytical, and visualisation tools provide a flexible and integrated metrics framework. Technology Delivering True Decision Support ICONIK is based on a secure, web based information platform that consolidates and standardises data from multiple project management and clinical sources, including CTMS, EDC, IVRS, laboratories, imaging and epro. ICON is the first CRO in the industry to incorporate Oracle s Life Sciences Data Hub in its platform, which provides a fully integrated clinical data environment, with strict version control and full traceability of data processing. ICONIK provides a central access point for both ICON and sponsor study teams to view the latest study information and trends. A powerful combination of business intelligence, analytical, and visualisation tools provide a flexible and integrated metrics framework that produces reports and metrics on subject areas ranging from site performance and regulatory submissions to patient profiles and adverse events. Visual representations of leading indicators from the data pool highlight potential operational and safety problems before they occur. A drill-down capability enables you to further explore any issues in greater detail. All operational and clinical reporting is accessible via the ICONIK Portal which facilitates dynamic team collaboration and information sharing.

3 Building on its reputation as one of the most successful and trusted CROs in the global pharmaceutical industry, ICON has revolutionised clinical trial processes using integrated technologies, significantly enhancing the efficiency and productivity of clients drug development programs. ICONIK is a powerful integrated information platform that consolidates, standardises and visualises operational and clinical data from multiple sources, to provide a single holistic view of all study information, from study start-up to database lock. ICONIK can analyse a blend of operational, quality, efficacy and clinical safety data across multiple studies and different therapeutic areas, making it one of the most effective tools in the industry for the proactive management of a clinical trial. ICONIK delivers true transparency across the complete drug development lifecycle, allowing you to turn your data into real knowledge, supporting better and faster decision making throughout the life of a trial. Transparency Accessibility Visualisation Collaboration Compliance True transparency across all areas of a study, including start-up, execution, query management, safety and site performance Secure, easy to use, web based access to study information with drill-down capability, allowing you to explore data and proactively address issues State-of-the-art visualisation tools allowing easier pattern and trend detection Online study team collaboration and document sharing in role-based environment with event and issue management capabilities 21 CFR Part 11 compliant providing a fully auditable chain of custody for clinical data, which is available for regulatory submission and post-submission queries

4 ICONIK - Revolutionising the Management of Clinical Trials Study Planning and Design PROJECT AND QUALITY MANAGEMENT Study Start-up Site Management and Monitoring Subject Enrolment SAFETY ANALYSIS Study Planning and Design Centralised access to historical operational and clinical data to guide protocol development Quicker evaluation of site feasibility with unique insights into best performing countries, sites, investigators and patient profiles Study Start-up Centralised access to information on regulatory submissions and approvals by study, centre, country and CRA Faster identification of delays or potential difficulties in site start-up Strategic analysis of sites with most efficient start-up cycles Subject Enrolment Centralised access to metrics for enrolments analysed by CRA, investigator and country Tracking of planned versus actual enrolments and randomisation Insights into patient eligibility and screening failures to improve retention rates Strategic analysis of best performing sites Site Management and Monitoring Access to a single source of real-time performance metrics for application of Adaptive Monitoring techniques Dynamic allocation of resources based on site performance metrics, eliminating unnecessary site visits Faster identification of protocol deviation and safety issues More efficient centralised monitoring Project and Quality Management Single source of data for study project and quality tracking, time and resource allocation Tracking of critical, major and minor observations from internal, client and regulatory audits Holistic management of project from a combined operational and clinical aspect Management of global study portfolios Safety Analysis Quick and easy patient profile creation process with immediate access to all relevant operational and clinical patient data Comparison of patient and safety events data across multiple studies by country, site, subject and severity Immediate identification of safety risks for early intervention Monitoring of lapses in scientific rigor

5 Tracking Operational Performance ICONIK provides a range of information that supports quality, performance management and efficient decisionmaking at a portfolio, study, country and site level. A simple to use Project Management Dashboard provides immediate access to a set of operational metrics including Quality Audit Tracking, Study Start-up & Submissions and Monitoring Visit Reports. These metrics provide critical support for the effective management and evaluation of the progress of a study in real-time, enabling you to quickly identity site feasibility, optimise patient enrolment and efficiently monitor site performance and regulatory compliance. Management and Harmonisation of Data ICONIK seamlessly integrates clinical data routinely generated by EDC systems, laboratories, imaging and IVRS, including adverse events, vitals and patient disposition. Using this data, a trial can be instantly evaluated from a scientific, safety and quality perspective across an entire compound or a single study. For example, screening and randomisation trends can be assessed by country, CRA or site or a safety analysis of the compound can be performed using adverse event data from multiple studies. Any operation, from the detection of a safety signal to the data quality analysis of a solitary site, can be performed in a few clicks and with minimal training. Information Sharing and Collaboration The ICONIK Portal is the central access point for both ICON and sponsor study teams to view the latest study information and trends in a secure, user friendly, clinical development environment.

6 ICON plc Corporate Headquarters South Country Business Park Leopardstown, Dublin 18 Ireland T: F: [email protected]