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General Capability

At the forefront of IVR & web technology for clinical studies. General Capability. Content. Interactive Technologies Overview Interactive Technologies Applications ICOPhone ICOPro ICO Web System Integration System Delivery Lifecycle Timelines Help desk support.

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General Capability

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  1. At the forefront of IVR & web technology for clinical studies General Capability

  2. Content • Interactive Technologies Overview • Interactive Technologies Applications • ICOPhone • ICOPro • ICO Web • System Integration • System Delivery Lifecycle • Timelines • Help desk support

  3. Interactive Technologies Founded in 2000 Led by division founders 7 offices in 3 countries, 200 employees 2005 – Highest ranked CRO IVR Provider

  4. Interactive Technologies – What We Do • Develop, implement, & manage interactive voice response (IVR) systems & interactive web response (IWR) systems • Increase the accuracy, efficiency, & cost savings of conducting clinical trials Accuracy Efficiency Cost Savings

  5. Interactive Technologies – Locations Dublin Marlow Chicago Philadelphia Raleigh Houston(HQ) 200+ Interactive Technology dedicated staff worldwide

  6. Project Team Structure

  7. Experience Profile

  8. Over 50 Languages Including:

  9. Interactive Technologies System ICOWeb ICOPhone ICOPro Interactive Technologies

  10. Interactive Technology Differentiators • Global reach, experience & resources • Division of ICON Clinical Research - full-service CRO • IVR/IWR integration • Robust, customizable, real-time reporting application • Fully-staffed, trained Help Desk, available 24/7 • System flexibility – “Client Friendly” • High repeat business (>85%) • “Preferred Provider” experience

  11. Interactive Technologies System Features • Proprietary IVR/IWR application • Site Activation/Deactivation • Screening/Re-Screening/Enrollment • Screen Failure/Discontinuation • Randomization • Drug Inventory Management • Emergency Unblinding • Confirmation fax/email sent after each transaction & available online • Comprehensive reporting capabilities through ICOWeb

  12. ICOPhone System Standards • Full system validation on each project • Monthly quality control reports • 21 CFR 11 Compliant Validation • Two fully redundant systems • Full data back-up (nightly/7days a week) • Tailored study specific procedures Reliability • Regularly monitored phone lines • 138 simultaneous calls - <20% capacity • ICOPhone  105,000+ calls monthly Capacity

  13. ICOPhone - Site Activation/Deactivation • Site activation & initiation • Indicates a site is ready to begin enrolling and triggers UserIDs to be sent to users • Authorizes optional initial shipment of drug to the site • Visit closure • Denies access for individual visits at site, country or study level • Study termination • Denies ICOPhone access to all users • Site suspension and/or deactivation • All user accounts are disabled, & ICOPhone access is denied for site staff • Drug can be suspended • Can immediately shut down individual users or the entire site

  14. ICOPhone - Screening/Re-screening/Enrollment • Built around inclusion/exclusion criteria • Allows assignment of patient identifiers • e.g. screening #, patient ID • “Caps” can be implemented by site, country or entire study to prevent over-enrolling • Collection of demographic data • Assignment of lead-in drug

  15. ICOPhone - Screen Failure/Discontinuation • Registers screen fails and discontinuations • Tracks reasons for withdraw • Allows for real-time tracking of subjects current status

  16. ICOPhone - Randomization • Manage complex randomization schemes • Multiple strata • Multiple patient cohorts/subsets • Programmable for dynamic randomization • Minimization, biased coin, dose titration, etc. • Randomization schedules generated by Biostatistics • Subjects assigned to treatment at randomization

  17. ICOPhone - Drug Management • Manage study drug inventory & track in real time • Allocate drug as needed • Reduces supply waste & costs • Allows for complex dosing of patients (titration studies) • Allows for flexible distribution of study supplies • Includes re-supplying subjects mid-study • Manage drug expiry • Forecasting/Projection Algorithms • Drug quantity projected based on patients’ progression • Utilize primary/secondary forecasting windows lag times included • Account for minus side of visit windows & stratification factors

  18. ICOPhone - Emergency Unblinding • Provide investigators with the ability to break study blind at any time • Automatically notifies sponsor of all code-breaks • Maintains blind with study team and monitors - unless otherwise specified by sponsor • Access to feature is controlled & requires proper user verification • Role-based and unique identification number

  19. ICOPhone Benefits What you want What ICOPhone delivers Proven record of delivery on time – 7 years & 400+ systems Meet go-live date Knowledgeable Project Manager Project Manager average experience – 5 years Responsive User Support 90% helpdesk calls handled on 1st call System Availability 99.99% availability Real-time data access Real-time web reports

  20. ICOPro • Proprietary electronic patient reported outcomes (ePRO) application • IVRS & IWRS • Eliminates data entry costs • Increases subject compliance • Reminder calls & alerts • Higher data quality – available in real-time

  21. ICOPro Logic • Eligibility calculations • Ability to determine if/when a subject should advance • screening => randomization • Adaptive branching • Ability to ask different questions based on subject responses • Forced Order • Subject must answer each question before continuing

  22. Benefits of ICOPro • Utilizing IVR &/or IWR reduces time & cost of data entry • Forces data entry confirmation • Diary data is clean & immediately available for review • No materials or device for subjects to lose • Mid-study changes are immediately available • Improved accuracy • System can enforce time window • Automatic alerts are sent to the site • e.g. subject missed diary, subject low compliance, safety alerts

  23. IVR/IWR Compared to PDA

  24. ICOWeb • Proprietary reporting application • Web-based & real-time • Accessible 24 hours per day • Suite of standard reports • Custom reports available • Export directly into Excel • Built-in filtering capability

  25. Interactive Technology System Quality Checks • Automated quality checks ensure proper system function • Quality checks run nightly & reports sent to project team • Project Managers complete quality management review reports once a month

  26. Systems Integration • Integrate directly with other clinical trial applications (CTMS, EDC, Lab Systems, etc.) • Real-time program information across study management tools • Experienced in multiple data transfer formats – e.g., ASCII, XML, CDISC, etc. • Can transfer any information collected in the IVR system

  27. System Delivery Lifecycle

  28. Phase 1 Business Development Phase 2 Planning Phase 3 Development Phase 4 Validation Phase 5 Installation Phase 6 Maintenance Phase 7 Retirement Interactive Technologies BD Gate Plan Gate Dev Gate SOL Gate Retire Gate System Delivery Lifecycle

  29. Phase 1 Business Development Phase 2 Planning Phase 3 Development Phase 4 Validation Phase 5 Installation Phase 6 Maintenance Phase 7 Retirement Interactive Technologies BD Gate Plan Gate Dev Gate SOL Gate Phase 1 • Study team assigned • Project file set-up • Handover from BD to Ops Retire Gate

  30. Phase 1 Business Development Phase 2 Planning Phase 3 Development Phase 4 Validation Phase 5 Installation Phase 6 Maintenance Phase 7 Retirement Interactive Technologies BD Gate Plan Gate Dev Gate Phase 2 • Initial set-up meeting w/team • User requirements development • System design completed • Validation plan created • Test scripts drafted • Trace matrix started • Voice prompts sent for translation recording SOL Gate Retire Gate

  31. Phase 1 Business Development Phase 2 Planning Phase 3 Development Phase 4 Validation Phase 5 Installation Phase 6 Maintenance Phase 7 Retirement Interactive Technologies BD Gate Plan Gate Dev Gate Phase 3 • Design handover meeting • System development • Code review • Unit/component testing • Functional testing/debugging • Formal test scripts finalized/approved SOL Gate Retire Gate

  32. Phase 1 Business Development Phase 2 Planning Phase 3 Development Phase 4 Validation Phase 5 Installation Phase 6 Maintenance Phase 7 Retirement Interactive Technologies BD Gate Plan Gate Dev Gate Phase 4 • Installation into validation environment • Formal system validation complete • Client UAT • Formal validation report issued SOL Gate Retire Gate

  33. Phase 1 Business Development Phase 2 Planning Phase 3 Development Phase 4 Validation Phase 5 Installation Phase 6 Maintenance Phase 7 Retirement Interactive Technologies BD Gate Plan Gate Dev Gate Phase 5 • Installation into production • Help desk training conducted • Investigator/user data loaded • Switch on live SOL Gate Retire Gate

  34. Phase 1 Business Development Phase 2 Planning Phase 3 Development Phase 4 Validation Phase 5 Installation Phase 6 Maintenance Phase 7 Retirement Interactive Technologies BD Gate Plan Gate Dev Gate SOL Gate Phase 6 • System in use • Monthly quality review • Help desk support • Client support Retire Gate

  35. Phase 1 Business Development Phase 2 Planning Phase 3 Development Phase 4 Validation Phase 5 Installation Phase 6 Maintenance Phase 7 Retirement Interactive Technologies BD Gate Plan Gate Dev Gate SOL Gate Phase 7 • System taken off-line • Final data transfer to client • Study files archived Retire Gate

  36. System Change Process • System changes follow SDLC • Change assessed to determine validation level • Mid-study changes immediately available • All changes are tracked

  37. Estimated Timelines

  38. Help Desk • 24 hours per day, 7 days per week • Project manager always on call • Email access & toll-free phone access • Direct access from system by pressing “0” • 140 languages supported • Trained on system & protocol • Calls reviewed monthly & monitored randomly • Quality measure • Identify trends/common issues

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