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Interactive Technologies At the Forefront of IVR & Web Technology for Clinical Studies Menu 2. Service Portfolio 1. Interactive Technologies Overview 3. Drug Management 4. ePro 5. System Delivery & Support 6. Appendix Interactive Technologies Overview « Menu Interactive Technologies Service Portfolio Three Integrated Applications ICOWEB ICOPHONE ePro Reporting application that summarizes study data for clients, Investigators and other partners in the trial Interactive Technologies’ branded IVRS platform. ICOPhone has a dual platform that allows for both IVRS (telephone) or IWRS (web) data access Electronic Patient Reported Outcomes (ePRO) application that allows subjects to enter diary or questionnaire data via the web or telephone « Menu ICON Divisional Structure Central Laboratories Clinical Research Development Solutions Medical Imaging « Menu ICON Clinical Research Structure and Services « Menu Interactive Technologies Operations Dublin, Ireland • Project Management Chicago, IL • Project Support • Project Management Marlow, UK • Project Support • Business Development • Project Support North Wales, Philadelphia • Project Management Support North• Project Carolina, PA • Biostatistics • Project Management • Finance • Project Support • Business Development and • Business Development Proposals • Contracts Houston, Texas (HQ) • Quality Operations • Quality Management • Technical Services • Project Support and Maintenance • Project Management • Help Desk • Quality Assurance Chennai, India • Project Support and Maintenance • Help Desk • Technical Services 300 dedicated staff worldwide « Menu Interactive Technologies Operations Marlow, UK • Project Support • Business Development Dublin, Ireland Chicago, IL • Project Management • Project Management • Project Support • Project Support North Wales, Philadelphia • Project Management North Carolina, PA • Project Support • Project Management • Biostatistics Houston, Texas (HQ) • Project Support • Quality Operations • Quality Management • Technical Services • Project Support and Maintenance • Project Management • Help Desk • Quality Assurance Chennai, India • Project Support and Maintenance • Help Desk • Technical Services 300 dedicated staff worldwide « Menu Interactive Technologies Operations Chicago, IL Dublin, Ireland • Project Management • Project Management • Project Support • Project Support Marlow, UK • Project Support North Wales, Philadelphia • Project Management North Carolina, PA • Project Support • Project Management • Biostatistics Houston, Texas (HQ) • Project Support • Quality Operations • Quality Management • Technical Services • Project Support and Maintenance • Project Management • Help Desk • Quality Assurance Chennai, India • Project Support and Maintenance • Help Desk • Technical Services 300 dedicated staff worldwide « Menu Interactive Technologies: Experience Profile Client Experience: XX Studies List therapeutic areas Total: XXX studies implemented worldwide (300+ active) - Multi-Lingual Support 65+ languages - Complex Study Support - Adaptive Randomization - Global Trial Support * (includes Minimization, Biased Coin, Dose Titration, etc.) « Menu System Guarantees Reliability • Two fully redundant systems • Full data back-up (nightly/7days a week) • Tailored study specific procedures « Menu Service Portfolio « Menu System Features and Benefits ICOPhone is ICON Clinical Research’s branded IVR/IWR system Features Benefits • • • • • • • 21 CFR Part 11 Compliant and ISO 9001:2000 certified Provides both a IVR and IWR platform to capture and store data User support available 24 hours/7 days/week Can transfer data to and from Sponsor compatible systems Displays data in real time web reports Produces call confirmations and alerts via fax or email to Sponsors and site personnel • • • It is completely customizable to the protocol requirements Allows Sponsors to monitor the progress of a study via web reports Sponsors can make mid-study decisions that can expedite the progress of a trial Allows a Sponsor to launch a study with a minimum amount of packaged drug « Menu Data Management and Integration • CTMS: IMPACT, TrialWorks, ICOTrial • EDC: Medidata Rave, PhaseForward Inform, OC RDC CTMS • Clinical Supply: Fisher, Aptuit, Almac, Catalent, Xerimis • Formats: Text file, XML, ASCII, CDISC, SAS • Methods: sFTP (secured file transfer protocol), Cyclone EDC Lab Systems « Menu Data Management and Integration Benefits: • Can 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, SAS, CDISC, etc. • Can transfer any information collected in the IVR system « Menu Sponsor- Data Management Commonly Used System Modules: Emergency Site Activation Deactivation Unblinding Benefits: • System provides a simple option for enabling and disabling the sites • Sponsors can modify site parameters through site flags or caps • Sponsors can receive alerts, reports and notifications when events occur « Menu Site – Data Management Commonly Used System Modules: • Subject Screening • Subject Randomization • Subject Discontinuation ensures promotes Efficiency Safety • Emergency Unblinding • Subject Resupply Benefits: • Screening helps determine if subject meet eligibility criteria • Randomization helps maintaining balance in treatment arms while maintaining the blind • Discontinuation helps Sponsors key metrics easy • Emergency unblinding expedites the Sponsor notification and reporting process to data Access « Menu Services Offered – Biostatistics • Randomization services – – – – – • List Specification Guidance Drug Supply Management Subject and Pack List Generation Complex and client specific randomization schemes Logistics of how randomization list is used in the IVR Adaptive trial design and logistics of implementation of these complex trial designs – Within the (sponsor) team and the technology – Bid defense (Business Development) « Menu Services Offered – Biostatistics • Dynamic randomization services – Presentations and publications for reference – Development of dynamic algorithm – Development of customized reports • Response adaptive randomization services – Other randomizations based on what is known at baseline – Randomization based on combining information from subject responses (Primary efficacy endpoint) • Can be stand alone or covariate baseline hybrid – Covariate baseline • Known stratification factors – Mostly phase II dose ranging studies – Consultation on ePRO • Which psychometric tool to select • How to best capture patient responses electronically « Menu Services Offered – Biostatistics • Consultation on ways to facilitate data integration – Lab data – EDC – IVR/IWR services • Consultation and design work for specialized statistical data reports on the web – Interim analyses – Adaptive trial design • Consultation on electronic clinical supplies management – Customized to protocol and dependant on triggers, expiry, supply availability, number and location of site and stratification « Menu Services Offered – Biostatistics • Consultation on designing longitudinal studies – Clinical trials or epidemiological studies • Knowledge of SAS programming and – – – – – • Data sets Data Integration Data base structures Client specific randomization EDC and data management Consultation on establishing patient registries « Menu Biostatistics - Randomization List Generation • Independent biostatistics team within Interactive Technologies: – Interactive Technologies Biostatistician and SAS programmer assigned to every project • Support the generation of many subject and pack randomization list designs including: – Replacement strategy – Re-randomization – Multiple stratification factors – Multiple drug ratios – Latin square « Menu Biostatistics - Randomization List Generation • Randomization list specifications captured in separate documents – Requirements documents are separate from main system requirements in order to: • Capture randomization list requirements in greater detail • Maintain the study blind • May contain additional logical rules • Approval of test and live subject/pack randomization Lists – Unblinded statistical services available • Approval of test and live randomization lists • Approval of list generation documentation • Confirmation of successful IVR system load « Menu Biostatistics – Adaptive Randomization • Statistical consultation is available for the management of mis-randomizations that have a higher consequence in an adaptive randomization. • ICON’s service regarding adaptive randomization also includes the development of customized web reports, available in real time to unblinded staff members. These three customized web reports: – Track the randomization events for individual subjects – Show the cumulative balance within strata by treatment groups – Show the impact of special cases on the randomizations « Menu Biostatistics – Adaptive Randomization • Eva Miller, Ph.D., Director, Biostatistics, Interactive Technologies, works with the project statistician to delineate the adaptive randomization algorithm in scientific terms such that the algorithm can be appended to the protocol. • The specification of the adaptive randomization algorithm must meet regulatory standards of replicability: – given a particular set of randomization counts, a probability value, and the logic of the algorithm, there can be one and only one treatment assignment per subject. • Following the algorithm specification, the client can provide simulations for “black box” testing or ICON Clinical Research can provide simulations for the client statistician’s review. « Menu Drug Management « Menu Drug Supply Management System Modules and Capabilities: • Automated drug ordering • Replace Kit Module • Resupply Expiration Tracking • Visit Projection • Inventory Tracking Benefits: • Comprehensive Inventory Management • Allows for a study to start with a minimum of packaged drug « Menu Drug Supply Management Study Coordinator calls System for subject resupply visit System selects the appropriate kit based on site inventory and study randomization scheme System sends resupply drug order to depot to resupply dispensed kits Sponsor can monitor site and study levels via alerts and web reports « Menu Drug Management Goal • ICON’s typical drug management scheme utilizes an algorithm that is successful in: – Minimizing the number of shipments created – Minimizing amount of drug wastage « Menu Site Drug Management Scheme – Visit Schedule • • A pre-defined visit schedule is needed for each treatment arm – User defines visit schedule – Expected visit day is defined for each visit – System uses visit schedule to ‘project’ when drug is needed at the site for each patient – Flexible enough for titrations Start and Stop Visits are configurable within the system – Start visit: when projection starts for a subject i.e. enrollment or randomization visit – Stop visit: when project ends for a subject. « Menu Site Drug Management Scheme – Short Window / Projected Need 1. • Short Window – timeframe used to determine the number of each kit type that will be allocated to active subjects at the site, that is to be included in the calculation of the Projected Need – Used to identify ‘if’ a shipment needs to be sent – Flag driven and defined in User Requirements Projected Need for each kit type – [(# of kits needed for each active subject to be supplied at all visits within the short projection window + trigger level value) - (# kits in transit + # kits available at the site + # kits pending at the site)] – If projected need for any kit type >/= 0 then shipment needs to be generated « Menu Site Drug Management Scheme – Long Window / Quantity to Ship 2. • Long Window – timeframe used to determine the number of each kit type that will be allocated to active subjects at the site, that is to be included in the calculation of the Quantity to Ship – Used to identify how much to send in a shipment – Flag driven and found in User Requirements Quantity to Ship – Identified for each kit type – [(# of kits needed for each active subject to be supplied at all visits within the LONG projection window + ‘RESUPPLY up to’ value) - (# kits in transit + # kits available at the site + # kits pending at the site) ] « Menu Site Drug Management Scheme – Short Window / Projected Need Projected Need for each kit type Short Window • • • Timeframe used to determine the number of each kit type that will be allocated to active subjects at the site, that is to be included in the calculation of the Projected Need Used to identify ‘if’ a shipment needs to be sent Phase II: Flag driven and defined in User Requirements • • [(# of kits needed for each active subject to be supplied at all visits within the short projection window + trigger level value) - (# kits in transit + # kits available at the site + # kits pending at the site)] If projected need for any kit type >/= 0 then shipment needs to be generated « Menu Site Drug Management Scheme – Long Window / Quantity to Ship Quantity to Ship Long Window • • • Timeframe used to determine the number of each kit type that will be allocated to active subjects at the site, that is to be included in the calculation of the Quantity to Ship Used to identify how much to send in a shipment Phase II: Flag driven and found in User Requirements • • [(# of Identified for each kit type [(# of kits needed for each active subject to be supplied at all visits within the LONG projection window + ‘RESUPPLY up to’ value) - (# kits in transit + # kits available at the site + # kits pending at the site) ] « Menu Site Drug Management Scheme – Long Window / Quantity to Ship 2. • Long Window – timeframe used to determine the number of each kit type that will be allocated to active subjects at the site, that is to be included in the calculation of the Quantity to Ship – Used to identify how much to send in a shipment – Flag driven and found in User Requirements Quantity to Ship – Identified for each kit type – [(# of kits needed for each active subject to be supplied at all visits within the LONG projection window + ‘RESUPPLY up to’ value) - (# kits in transit + # kits available at the site + # kits pending at the site) ] « Menu Depot Drug Management • Most xxx (Client Specific) studies include: – a depot to depot shipment request IWR module. • Drug can only be moved from a main depot to a sub depot – Ability to handle depot to depot drug management via trigger and re-supply values • Values are flag driven and can be updated. « Menu ePRO « Menu Subject Data Management (ePro) What is ePro? Benefits: ICON’s proprietary electronic patient reported outcomes (ePRO) application • Eliminates data entry costs • Increases subject compliance • Reminder calls & alerts • Higher data quality • Can be delivered via IVRS / IWRS • Supports Multiple Languages Subject enters diary into application ePro stores data in database Sponsors can receive alerts or can view data via reports in real time « Menu ePro Logic • Eligibility calculations – • Adaptive branching – • Ability to determine if/when a patient should advance (screening => randomization) Ability to ask different questions based on patient responses Forced order – Patient must answer each question before continuing « Menu ePro Benefits • Reduces time & cost of data entry (forces data entry confirmation) • Increased patient compliance • Increased data quality • No paper or device for patients to lose • System can enforce time window improving accuracy of data « Menu System Demonstration Access Details • Phone: 800-594-4977 • Web: icophone.iconplc.com • Demo User ID: 10000 • Demo Pin: 9999 « Menu ICOWeb - System Reports Reporting • Web-based, Real-time • Ability to be exported to Excel, data filtered • Standard and custom reports available Standard Reports • Study at a Glance • Shipment History • Site Inventory • Visit Summary • Site Status • Depot Inventory • Screening • Enrollment/Randomization • Discontinuation « Menu System Delivery and Support « Menu INTERACTIVE TECHNOLOGIES Phase 1 Business Development BD Gate Phase 2 Planning 4 WEEKS Plan Gate Phase 3 Development 4 WEEKS Dev Gate Phase 4 Validation 2-3 WEEKS +1 WEEK UAT TESTING Phase 5 Installation 1 WEEK System Delivery Lifecycle SOL Gate Phase 6 Maintenance Retire Gate Phase 7 Retirement « Menu Estimated Timelines Task Average time Study award to final user requirements 1-4 weeks System design and programming 3-4 weeks System testing and validation 2-3 weeks User acceptance testing 1 week Final installation 1 week Average time from final UR: 7-9 weeks « Menu Project Team Structure – Development Phase Vice President Project Operations Group Manager Project Implementation Client Manager Project Manager Project Implementation Assistant Project Manager Technical Analyst Programmer/ Developer Business Analyst Validation Specialist « Menu Project Team Structure – Maintenance Phase Vice President Project Operations Group Manager Project Support Client Manager Project Manager Support Services Project Lead (if applicable) Project Support Analyst(s) Call Center « Menu Communication Path Business Development Vice President Global Data & Technical Services Vice President Project Operations Client Management Group Manager Project Manager « Menu User Acceptance Testing (UAT) • System will be made available for testing prior to implementation • Testing will be supported by the project team • Changes and/or defects are reported, tracked and corrected • Upon acceptance, system is formally validated and installed « Menu System Support: Call Center / Help Desk • Available 24/7/365 • Staffed by ICON employees • E-mail access & toll-free phone • Direct access from system by pressing “0” • 140 languages supported • Trained on technical components of system per protocol • Calls routinely reviewed for quality • Data change procedures « Menu User Training • Typically conducted by the Project Manager at the Investigator Meeting, Web Teleconference or Site focused • Brochures and instruction packets provided for subjects and site personnel • Practice system available for sites and subjects • CRA training is recommended for facilitating training of new site personnel « Menu Core Values • Exceptional customer satisfaction • Technology as a solution • Promotion of education and self-improvement • Teamwork environment • Promoting accountability • Constant improvement « Menu Our Value Proposition Promotion of education and self-improvement Teamwork environment Constant improvement Exceptional customer satisfaction Core Values Technology as a solution Promoting accountability Appendix « Menu Site Drug Management Scheme – Visit Schedule Example • Visit 1 is randomization in this example Visit Number Days from Randomization Randomized Treatment Arm Kit Type Quantity 2 21 A 1 1 2 21 B 2 1 3 42 A 1 1 3 42 B 2 1 « Menu Site Drug Management Scheme – Example Patient 1 Treatment Arm A W2 Dispense Patient 2 Treatment Arm A W4 Dispense W4 Dispense W6 Dispense W6 Dispense 14 days • • 42 days Values – 2 Available Kit Types 1 at Site – Trigger Value is 2 – Re-supply Value is 4 – Short Window is 14 – Long Window is 28 Projected Need – Does Shipment need to be generated? – • 28 days 2 (# needed SW) + 2 (Trigger) – 2 (at site) = 2 which is >= 0 Quantity to Ship – How much needs to be shipped? – 4 (# needed LW) + 4 (Re-supply) – 2 = 6 « Menu Randomization List / Pack list relationship Randomization List Block # Rand # Treatment Arm 1 1 Active 1 2 Active 1 3 Placebo 1 4 Placebo 2 5 Placebo New Subject 2 6 Active New Subject 2 7 Active 2 8 Placebo New Subject New Subject New Subject New Subject New Subject Pack List Treatment # (Pack #) Treatment Arm 15988 Placebo 23356 Placebo 26584 Active 26889 Active 32556 Active 42865 Placebo 55544 Active 65585 Placebo Randomization List / Pack list relationship Randomization List Block # Rand # Treatment Arm 1 1 Active New Subject 1 2 Active New Subject 1 3 Placebo New Subject 1 4 Placebo 2 5 Placebo 2 6 Active 2 7 Active 2 8 Placebo New Subject New Subject New Subject New Subject Pack List Treatment # (Pack #) Treatment Arm 15988 Placebo 23356 Placebo 26584 Active 26889 Active 32556 Active 42865 Placebo 55544 Active 65585 Placebo Site – Data Management Commonly Used System Modules: promotes • Subject Screening Efficiency • Subject Randomization • Subject Discontinuation • Emergency Unblinding • Subject Resupply Benefits: • Screening helps determine if subject meet eligibility criteria • Randomization helps maintaining balance in treatment arms while maintaining the blind • Discontinuation helps Sponsors key metrics easy • Emergency unblinding expedites the Sponsor notification and reporting process to data Access ensures Safety « Menu Site – Data Management Commonly Used System Modules: promotes • Subject Screening Efficiency • Subject Randomization • Subject Discontinuation • Emergency Unblinding • Subject Resupply Benefits: • Screening helps determine if subject meet eligibility criteria • Randomization helps maintaining balance in treatment arms while maintaining the blind • Discontinuation helps Sponsors key metrics easy • Emergency unblinding expedites the Sponsor notification and reporting process to data Access ensures Safety « Menu Clinical Data Repository Data Analytics & Online Reports Data Management Quality Metrics LHS Clinical Operations Quality Metrics Data Cleaning, data reconsilation & data consistency reports Patient profile, patient safety reports - Clinical Research - Medical Imaging - Development Solutions - Central Laboratories DM, Clinical, Medical Reports Data consolidation for CDISC SDTM submissions