general capability at the forefront of ivr & web technology for clinical studies

General Capability

At the forefront of IVR & web technology for clinical studies

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

Project Team Structure

Experience Profile

Over 50 Languages Including:

Interactive Technologies System

Interactive Technologies

ICOWeb

ICOPhone ICOPro

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

IVR/IWR Compared to PDA

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

System 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

System Delivery LifecycleSystem Delivery Lifecycle


Phase 2

Planning

Phase 1


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


Phase 2

Planning

Phase 1


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


Phase 2

Planning

Phase 1


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


Phase 2

Planning

Phase 1


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


Phase 2

Planning

Phase 1


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


Phase 2

Planning

Phase 1


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


Phase 2

Planning

Phase 1


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

Estimated Timelines

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

general capability at the forefront of ivr & web technology for clinical studies

Documents

system validation

entire study

site staffdrug

randomization schedules

patient idcaps

simultaneous calls icophone

sitevisit closuredenies

redundant systems