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

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

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

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 EfficiencyCost Savings

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

6. Project Team Structure

7. Experience Profile

8. Over 50 Languages Including:

9. Interactive Technologies System Interactive Technologies ICOWeb ICOPhoneICOPro

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

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

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

26. 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

27. 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

28. System Delivery Lifecycle

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

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

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

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

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

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

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

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

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

38. Estimated Timelines

39. 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