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IRT Storybook
Dawn Sorenson, Amgen
Laurin Vincent, Genentech
Topics to be discussed together today…
1. Key Considerations for
IRT Strategy
Development
2. Internal Governance
Structure and Resource
Allocation
3. Outsourcing Trends and
Challenges in IRT - IF and
HOW Various Models
Matter
Topic Introduction
Discussion
IRT Strategy Roadmap
Overall
Strategy
System
Oversight
Roles &
Responsibilities
Standardization
Resourcing
Sourcing
Models
Governance &
Oversight
UAT
Key Considerations for IRT Strategy
Development
Topic 1
Key Considerations for IRT Strategy Development
Topics
• Outsourcing Trends &
Strategy
• Ownership and Budget
• System Type and Usage
• Total Cost of Ownership
• Company Size and Culture
Outsourcing Trends & Strategy
Movement in Outsourcing
Tactical Outsourcing
• Study by study focus
• Competitive bidding
• Inconsistent performance monitoring and governance
• Limited sponsor - supplier relationship
Preferred Provider
• Quasi-strategic
• Better than average timelines and prices
• Some metrics / governance established
• Moderate sponsor - supplier relationship
Strategic Outsourcing
• Integrated program outsourcing
• Identify a few strategic partners
• Performance monitoring through robust metrics reviewed regularly
• Well defined governance structure
• Equal seat at the table partnership relationship
FSP
Single Supplier
Strategic
Multi-supplier
Tactical
IRT Ownership and Budget
Roles and Responsibilities
• Who owns IRT in your organization?
– Study Management
– Clinical Supplies
– Systems Operations
– Others?
• Is the IRT currently being outsourced, in-house, or mix?
• How is UAT supported in your organization?
• Do you build an internal team to support IRT?
• Do you rely on the supplier or CRO to support IRT?
System Type and Usage
What Type of Systems to Use?
• Off the shelf system
• Software as a service (SaaS)
• Fully configurable
• Custom developed
• In house
The type of system to use is driven by the level of standardization
defined in your IRT strategy.
System Type and Usage
How Do You Use the System?
• Interface type: IVR, IWR, IMR (app)
• Phase of studies that use IRT
• Randomization / Enrollment
• Drug supply management
• Subject management; subject progression tracking
• Drug reconciliation, bar code scanning of product
• Integrating with other key systems; eg, CTMS, EDC, ERP
• Compliance tool
• ePRO / eDiary
Total Cost of Ownership
Key Considerations
• Direct cost of acquiring services
• Operating costs
• Resource costs
• Maintenance costs
Your IRT strategy should take the total cost of ownership into consideration.
Discussion Points
• How many of you have an IRT strategy at your
organization?
• Who developed the strategy?
• Who maintains the strategy?
• Is the strategy being followed?
• What advantages / disadvantages do you see to having a
strategy around IRT?
• How does company size and culture impact your strategy?
Internal Governance Structure and Resource
Allocation
Topic 2
Internal Governance Structure and Resource Allocation
Topics
• Standardization
• Resourcing
• System Oversight
• UAT
Standardization
Should You Standardize?
PROS CONS
Consistent across studies Maintenance of standards
Faster timelines for set-up Keeping up with technology / platform
Less rework Maintaining across multiple suppliers
Higher quality/ more reusable
functionality
In-house expertise to support
standards
Data quality through protocol to
submission
Difficult to know how much to
standardize
Configurability vs. customization — what are the pros/cons with each?
Resourcing
Best Practices
• Consider all areas; eg, clinical supplies, data management,
study management, clinical systems, biostatistics
• Ensure all impacted stakeholders have adequate
resourcing to support your IRT strategy
• Ensure UAT model is appropriately resourced
• Ensure adequate coverage for system oversight including
governance
Resourcing should align with your IRT strategy.
System Oversight
Benefits to Internal IRT Expertise
• Understand Sponsor-specific procedures and needs
• Internal advocate for IRT processes
• Understand IRT terminology as it relates to protocol design
• Increases effective communication to IRT suppliers
• Streamlines system build process
• Clear line of escalation and/or support for issue resolution
Internal IRT expertise can become an effective liaison
between supplier and study team members
UAT
Model Options
Model Pros Cons
Use supplier-generated scripts
to perform UAT (Happy Path
Testing)
• Simple to execute with little
preparation required
• Testers do not need to
understand IRT systems to
execute scripts
• Mimic supplier validation,
may not catch certain
errors
• May not include all
scenarios intended by
clinical team
Sponsor stakeholders perform
independent / informal UAT
without supplier-generated
scripts
• Stakeholder flexibility in
“testing” the system
• May be able to catch
certain errors
• Documentation may be
inconsistent and minimal
• Requires some preparation
and coordination with
supplier and/or stakeholder
Independent internal sponsor
group to manage and perform
UAT
• Full documentation of UAT
in consistent manner
• Catch more errors and
ensure errors are properly
resolved
• Requires technical skill set
• Resources required
• UAT vs validation in test
script planning
Discussion Points
• Does your organization have a dedicated IRT team?
• How much do you standardize?
• How does your organization perform UAT?
• What challenges have been faced with internalizing an
IRT? How have they been resolved?
• What are the different ways to provide oversight to a
supplier when they own the system?
Networking Break * 10:00 -10:30
Outsourcing Trends and Challenges in IRT
IF and HOW Various Models MatterTopic 3
Outsourcing Trends and Challenges in IRT
IF and HOW Various Models Matter
Topics:
• Pros/Cons for Different Sourcing
Approaches
• Benefits of Strategic Sourcing
• Governance / Oversight
Sourcing Models
Pros / Cons
Model Pros Cons
Single or sole
Sourcing
• Strong partnership
• Leverage relationship to
reduce costs
• Dedicated supplier staff
• No back-up supplier
• Long onboarding time for new
supplier
• IRT risky category
• Timelines critical for study start-up
Primary
Provider
w/back-up
• Strong partnership
• Risk mitigation with back-up
• Leverage relationship to
reduce cost
• Maintaining a back-up only supplier
is challenging
• Negotiating power limited with back-
up
Program /
molecule level
sourcing
• Continuity and efficiencies
within the program with
Sponsor and Supplier
• Dedicated supplier staff
• Difficult to balance portfolio across
suppliers
• Line of sight limited to program
Competitive
bidding
(preferred / non
preferred)
• Study team makes decisions
• Cost can be negotiated at
study level
• No strategic planning with suppliers
• No balance of work across supplier
• Difficult for further leverage
• More suppliers is harder to manage
Location / Site
specific
• Localized support by region
• Little time zone issues
• Limits supplier choices
• Most suppliers are global anyway
Sourcing Evaluation
How to Source in IRT?
Situational Analysis
• Different models are appropriate for different Sponsors and service areas
• What are the drivers (e.g. cost, quality, timelines, culture, size, leadership, etc.)?
Internal Landscaping
• Technology appetite
• Assess IRT support structure internally
• Risk tolerance level
• Resources
External Landscaping
•Market research•Sourcing initiatives (RFI, RFP, etc.)•Alignment with organization’s culture
Business
Needs
Benefits to Strategic Sourcing
• Reduced cost with improved supplier predictability
Quality • Greater system standardization will drive efficiencies
and reduce custom programming (reduce errors)
Cost
Time• Faster set-up time by avoiding competitive bidding
• Potential to move off critical path
• Reduce complexity; study prioritization within TA Service
• Reduce internal resource for selection, set-up & oversight
• Line of sight allows for better planning & higher quality PMs
Simplification
Resource
Benefits Non-Study Level Competitive Bidding: Strategic Sourcing
• TA specific standards; shorter learning curve for teams
Sites • Develop familiarity with same supplier’s system
Innovation • Faster, preferential access to supplier innovation
Governance & Oversight
Do You Need It With IRT?
• Sponsor Responsibility (ICH E6)
– 5.2.1 A sponsor may transfer any or all of the sponsor’s trial-related duties
and functions to a CRO, but the ultimate responsibility for the quality and
integrity of the trial data always resides with the sponsor…
• High risk category
• Dedicated People at Sponsor and Supplier to manage the relationship
• Key Performance Indicators and Metrics
• Auditing and Monitoring Activities
• Quality Language in Service Agreements
Issu
e
Res
olu
tio
n
StrategicExecutive forum for outlining business
strategies
Operational
Cross functional participation as required
Resolution of issues escalated from the Functional Level
Functional
Oversight of daily operations support
Resolution of issues escalated from study team
Governance StructureStandard Approach
High
Vo
lum
e of Issu
esLow
Sev
erit
y o
f Is
sues
Low
High
Discussion Points
• Have you found a specific sourcing approach to be more
valuable for your organization (e.g. competitive bidding,
alignment, strategic, etc.)?
• Anything special or unique with outsourcing of IRT?
• Does 3rd party outsourcing of IRT have a positive or
negative impact on you (e.g. outsourcing IRT through the
CRO)?
• What have you found to be most effective for governance in
IRT?
At the end of the day…
1. Develop a company strategy around IRT
2. Socialize strategy, gain buy-in
3. Provide appropriate level of governance and oversight to support the
strategy
4. Be flexible as it will change
5. Sourcing models vary in benefit based on Sponsor organization’s
needs, culture, and maturity in IRT space
6. Many cases, more strategic models will offer more benefit to both the
Sponsor and supplier
7. IRT SME’s within the Sponsor organization are very useful
Thank you for your participation!
