general capability at the forefront of ivr & web technology for clinical studies
TRANSCRIPT
Content
• Interactive Technologies Overview
• Interactive Technologies Applications
– ICOPhone
– ICOPro
– ICO Web
• System Integration
• System Delivery Lifecycle
– Timelines
• Help desk support
Interactive Technologies
2005 – Highest ranked CRO IVR Provider
7 offices in 3 countries, 200 employees
Founded in 2000
Led by division founders
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
Interactive Technologies – Locations
Dublin
200+ Interactive Technology dedicated staff worldwide
Philadelphia
RaleighHouston
(HQ)
MarlowChicago
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
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
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
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
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
ICOPhone - Screen Failure/Discontinuation
• Registers screen fails and discontinuations
• Tracks reasons for withdraw
• Allows for real-time tracking of subjects current
status
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
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
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
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 1st call
System Availability99.99% availability
Real-time web reports
Proven record of delivery on time – 7 years & 400+ systems
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
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
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
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
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
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
Interactive TechnologiesInteractive Technologies
Phase 2
Planning
Phase 1
Business Development
Phase 3
Development
Phase 4
Validation
Phase 5Installation
Phase 6
Maintenance
Phase 7
Retirement
BD Gate
Plan Gate
Dev Gate
SOLGate
Retire Gate
System Delivery LifecycleSystem Delivery Lifecycle
Interactive TechnologiesInteractive Technologies
Phase 2
Planning
Phase 1
Business Development
Phase 3
Development
Phase 4
Validation
Phase 5Installation
Phase 6
Maintenance
Phase 7
Retirement
BD Gate
Plan Gate
Dev Gate
SOLGate
Retire Gate
Phase 1• Study team assigned
• Project file set-up
• Handover from BD to Ops
Interactive TechnologiesInteractive Technologies
Phase 2
Planning
Phase 1
Business Development
Phase 3
Development
Phase 4
Validation
Phase 5Installation
Phase 6
Maintenance
Phase 7
Retirement
BD Gate
Plan Gate
Dev Gate
SOLGate
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
Interactive TechnologiesInteractive Technologies
Phase 2
Planning
Phase 1
Business Development
Phase 3
Development
Phase 4
Validation
Phase 5Installation
Phase 6
Maintenance
Phase 7
Retirement
BD Gate
Plan Gate
Dev Gate
SOLGate
Retire Gate
Phase 3• Design handover meeting
• System development
• Code review
• Unit/component testing
• Functional testing/debugging
• Formal test scripts finalized/approved
Interactive TechnologiesInteractive Technologies
Phase 2
Planning
Phase 1
Business Development
Phase 3
Development
Phase 4
Validation
Phase 5Installation
Phase 6
Maintenance
Phase 7
Retirement
BD Gate
Plan Gate
Dev Gate
SOLGate
Retire Gate
Phase 4• Installation into validation
environment
• Formal system validation complete
• Client UAT
• Formal validation report issued
Interactive TechnologiesInteractive Technologies
Phase 2
Planning
Phase 1
Business Development
Phase 3
Development
Phase 4
Validation
Phase 5Installation
Phase 6
Maintenance
Phase 7
Retirement
BD Gate
Plan Gate
Dev Gate
SOLGate
Retire Gate
Phase 5• Installation into production
• Help desk training conducted
• Investigator/user data loaded
• Switch on live
Interactive TechnologiesInteractive Technologies
Phase 2
Planning
Phase 1
Business Development
Phase 3
Development
Phase 4
Validation
Phase 5Installation
Phase 6
Maintenance
Phase 7
Retirement
BD Gate
Plan Gate
Dev Gate
SOLGate
Retire Gate
Phase 6• System in use
• Monthly quality review
• Help desk support
• Client support
Interactive TechnologiesInteractive Technologies
Phase 2
Planning
Phase 1
Business Development
Phase 3
Development
Phase 4
Validation
Phase 5Installation
Phase 6
Maintenance
Phase 7
Retirement
BD Gate
Plan Gate
Dev Gate
SOLGate
Retire Gate
Phase 7• System taken off-line
• Final data transfer to client
• Study files archived
System Change Process
• System changes follow SDLC
• Change assessed to determine validation level
• Mid-study changes immediately available
• All changes are tracked
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