Transcript ITG-GenCapabilities-amended 9.65 MB Feb 07 2011

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
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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
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ICON Divisional Structure
Central Laboratories
Clinical Research
Development Solutions
Medical Imaging
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ICON Clinical Research Structure and Services
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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
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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
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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
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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.)
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System Guarantees
Reliability
• Two fully redundant
systems
• Full data back-up
(nightly/7days a
week)
• Tailored study
specific procedures
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Service Portfolio
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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
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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
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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
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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
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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
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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)
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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
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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
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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
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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
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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
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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
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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.
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Drug Management
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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
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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
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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
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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.
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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
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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) ]
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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
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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) ]
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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) ]
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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.
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ePRO
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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
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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
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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
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System Demonstration Access Details
•
Phone:
800-594-4977
•
Web:
icophone.iconplc.com
•
Demo User ID:
10000
•
Demo Pin:
9999
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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
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System Delivery and Support
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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
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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
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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
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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
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Communication Path
Business Development
Vice President
Global Data &
Technical Services
Vice President
Project Operations
Client Management
Group Manager
Project Manager
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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
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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
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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
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Core Values
•
Exceptional customer satisfaction
•
Technology as a solution
•
Promotion of education and self-improvement
•
Teamwork environment
•
Promoting accountability
•
Constant improvement
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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
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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
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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
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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