The document outlines a webinar on interactive response technologies (IRT) presented by Ryan Michaud and Bruce Bailey, detailing the features and capabilities of IVR/IWR systems used in clinical research. It discusses various aspects such as visit tracking, randomization methods, investigational product management, and electronic patient reported outcomes (ePRO). The webinar emphasizes the flexibility, cost-effectiveness, and utility of these technologies in enhancing data management and patient engagement during clinical trials.

1. 2 0 1 1 FA L L B I O M E T R I C S W E B I N A R S E R I E S
IVR/IWR...More than just Randomization
Oct. 11, 2011 Presented by Ryan Michaud and Bruce Bailey

2. Ryan Michaud
 Senior Project Manager, Interactive
Response Technologies (Voice/Web)
 8+ years of clinical research experience
 Overseen the successful development of
more than 100 IVR/IWR systems
 BS in Computer Science from Central
Connecticut State University
2011 FALL BIOMETRICS WEBINAR SERIES

3. Bruce Bailey
 Executive Director, IVR/IWR Application Development
 15+ years of clinical research experience
 Overseen the successful development of more than 150
IVR/IWR systems
 BS in Electrical Engineering from Northeastern University
and an MBA from Rensselaer Polytechnic Institute
2011 FALL BIOMETRICS WEBINAR SERIES

4. Agenda
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 Interactive Response Technology (IRT) Overview
 Visit Tracking
 Randomization
 Investigational Product (IP) Management
 Drug Accountability
 Electronic Patient Reporting Outcome (ePRO)
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5. Interactive Response Technologies
Voice and web options
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6. IRT Overview
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 Automated on-line user registration and approval
 Visit tracking with management of washout, open-label and
rescue medication, dose titration and computation
 Interim visit reporting, subject medication resupply
 Cohort and site permission management
 Study discontinuation visits and monitoring (completion, early
termination, break blind)
 Broad spectrum of randomization types including central,
stratified, adaptive, dynamic and biased coin, etc.
 Electronic patient diary capabilities (ePRO) including outbound
reminders and automated compliance reporting
2011 FALL BIOMETRICS WEBINAR SERIES

7. Flexibility and Convenience
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 Trials can utilize both IVR and IWR systems, allowing
users the flexibility to switch between systems during
the conduct of a trial
 On-line registration provides the convenience
registering anywhere you have an internet connection,
and the security of allowing trial administrators to
manage user access and trial participation
 Multi-Lingual availability
2011 FALL BIOMETRICS WEBINAR SERIES

8. Visit Tracking
 More than collecting visit dates
 Commons visits include screening, washout,
interim study visits with/without investigational
product resupply and discontinuation visits
(completion, screen failure or early termination
 Dose tolerability, computation and titration
(double-blind and open-label)
2011 FALL BIOMETRICS WEBINAR SERIES

9. Visit Tracking and Management
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Cohort Management Site Permission Management
 Automatic enrollment cap  Trial administrator controlled
 Flexible to DMC analysis  Global or site-specific
 Trial administrator controlled  By module
 Global or custom notification  Enrollment management,
 Easily updated parameters permission-based
based on study needs  More control with site initiation
2011 FALL BIOMETRICS WEBINAR SERIES

10. Randomization
 Randomization and dispensing
 Randomization and eligibility
 Types of randomization
– Central
– Central by block
– Stratified…not just once!
– Adaptive and dynamic
– Biased Coin
2011 FALL BIOMETRICS WEBINAR SERIES

11. Randomization
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Stratification
 Case example, stratified by:
– Country/Region
– Risk factor
– Sub-study participation (Holter, etc.)
– Current smoking status
 Since country/region is fluid (countries added
and removed during the conduct of the trial)
the above stratification was implemented
dynamically.
2011 FALL BIOMETRICS WEBINAR SERIES

12. Investigational Product Management
 Enrollment rate and inventory…planning is a
MUST!
 No study too BIG or small
 ITK – In the Know with reporting and alerts
 Automated ordering based on threshold and
trigger or predictive algorithms
2011 FALL BIOMETRICS WEBINAR SERIES

13. Investigational Product Management
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 Supply management at site and depot level
 Depot specific or regional supply management
 International or multi-depot management
 Drug expiry tracking and rotation
 Multipart or country specific labeled kits
 Automated reporting and reconciliation of
temperature excursions
 Full drug reconciliation capabilities
 Predictive – it’s possible! And we’re doing it…
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14. Balancing Enrollment and IP Supply
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Utilize predictive
ordering algorithm
to help trials
FIND BALANCE…
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15. Drug Accountability
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 Helps clients in utilizing a uniform IP reconciliation standard
 Provides end users with the ability to track and manage drug
returns from the study sites back to a central depot
Subject IP Depot
assigned Subject reconciled IP shipped processes
IP returns IP and to depot returns
confirmed
2011 FALL BIOMETRICS WEBINAR SERIES

16. Electronic Patient Reported Outcomes (ePRO)
 IVR/IWR based ePRO systems are cost effective
 The ‘thin-client’ model (phone or browser) is readily
available to nearly all patients throughout the world
 Use of an IVR/IWR system ensures timely and accurate
capture of patient data
 System is feature rich with robust reporting capabilities
and a cost effective solution
2011 FALL BIOMETRICS WEBINAR SERIES

17. IRT ePRO: Flexibility
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Middle-Weight Solution
 IVR/IWR based ePRO systems are growing increasingly
popular
 Optimal solution that provides a level of automation and
control not found with paper but without the expense or
complexity of a hand held device
Availability
 Systems can be translated into any language necessary and
are available throughout the world via a ‘thin-client’ – phone
or browser
2011 FALL BIOMETRICS WEBINAR SERIES

18. IRT ePRO: Data
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Systems can be configured to capture any data that can be
represented numerically or via a ‘drop-down’ including:
1) Pain scores on a scale of 0-10
2) Quality of life
3) Quality of analgesia
4) Rescue medication use
– Number of pills
– Date and time taken
2011 FALL BIOMETRICS WEBINAR SERIES

19. IRT ePRO:
Data & InclusionExclusion Criteria
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 Since the ‘core’ IVR/IWR is running on the same
platform as the ePRO system, data captured via the
ePRO system can be used to determine subject
eligibility prior to randomization
– E.g., The randomization module checks:
– The average baseline pain score and requires a
value of 3-9
– At least 4 of 7 diary entries completed in the 7
days immediately prior to randomization
2011 FALL BIOMETRICS WEBINAR SERIES

20. IRT ePRO: Features
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Data Capture Frequency & Timing
 Systems can be set up to capture data at any frequency (e.g.,
1Xd, 2Xd, 3Xd or ad-hoc)
 System can further be configured to only capture data during
specific times (e.g., morning assessments between 8 and noon,
evening assessments between 8 and midnight)
Alerts
 System can be used to send automated alerts to ePRO users
 Text message, email or phone calls to remind callers to take
their IP or as a reminder to make a diary entry
2011 FALL BIOMETRICS WEBINAR SERIES

21. IRT ePRO: Built in ‘Business Logic’
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 Built in business logic prevents the entry of ‘bad’ data allowing
entry of valid responses
 All data entries are confirmed by the user before being
‘submitted’ to the system
– Once confirmed and submitted by the user, the data cannot
be changed
 ePRO questions asked can vary depending on the patients
status
2011 FALL BIOMETRICS WEBINAR SERIES

22. IRT ePRO: Reporting
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 Data captured is available to the project team in near real-time
 Data reports are shown in contextual format (e.g., in a PDF
calendar format) and serial format
 All data can be exported to Excel or PDF
 Compliance reports are also available
– Compliance reports show the total number of diary entries
expected and total received
– Reports show compliance by patient, by site, and globally for
the entire study
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23. Summary
 IVR/IWR Systems…more than just randomization
– Extensive inventory capabilities including
accountability
– A cost effective and middle-weight alternative for
Electronic Patient Reported Outcome
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24. Upcoming Webinars
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Register at www.premier-research.com/webinars
▪ Streamlining Data Management Start-up
15 November at 11:00 am EST
Speaker: Cheryl Silva
▪ Strategies for Implementing CDISC
13 December at11:00 am EST
Speaker: Thomas Kalfas
Listen to past webinars:
▪ The Role of Data Monitoring Committees
Speaker: Ron Kershner, Ph.D.
2011 FALL BIOMETRICS WEBINAR SERIES

25. Questions?
Ryan Michaud
Senior Project Manager, Interactive Response Technologies (Voice/Web)
Email: ryan.michaud@premier-research.com
Phone: 860.610.5510
Bruce Bailey
Executive Director, IVR/IWR Application Development
Email: bruce.bailey@premier-research.com
Phone: 860.610.5511
www.premier-research.com
2011 FALL BIOMETRICS WEBINAR SERIES