This document summarizes a presentation on Johnson & Johnson's implementation of Veeva's study start-up solution. It discusses J&J's global presence, their partnership with Veeva, and the drivers and expected value of implementing a unified study start-up system. The presentation outlines J&J's implementation approach, focusing on key areas like the implementation team, configuration, deployment, training, and leadership support. It also covers factors impacting investigational sites and anticipated outcomes of a successful deployment. The overall goals are to speed up study start-up, provide better visibility and oversight, increase efficiency, and transform J&J into a sponsor of choice.

1. Transforming Study Start-up in a Global
Environment
Veeva R&D Summit
September 2018
Lisa Rakebrand, Director, Johnson & Johnson
Ashley Davidson, Sr. Director, Veeva Systems

2. 2
Agenda
• J&J Global Presence and Partnership with Veeva
• Study Start-up Solution: Drivers and Expected Value
• Implementation Approach
• Conclusion/Q&A
Disclaimer: These are our personal views; not company views.
This content may not be distributed or re-used in other presentations or publications without the consent of the author.

3. 3
• Consumer, Medical Device,
Pharmaceuticals
• 36 countries
• 58 legal entities
• 3500+ total FTE
Johnson & Johnson Global Presence

4. 4
Our Partnership with Veeva
Veeva applications
used at J&J
Customer-centric
approach to product
development
Veeva is a preferred
J&J provider

5. Study Start-up Solution: Drivers and Expected Value

6. 6
Organizations Aim to Speed Study Start-up
Top drivers to improve study start-up
Source: Veeva 2018 Unified Clinical Operations Survey
To the extent your organization has a study start-up improvement initiative underway, what are the most important drivers? (Q16)
Percent of respondents using a study start-up system, N=71

7. 7
Catalysts for Change: Study Start-up Challenges
Limited
Automation
Lack of Real-
Time Visibility
Paper-based
Collaboration
& Document
Exchange
Difficult to
Leverage
Intelligence
Across the
Org
Desktop trackers
Manual steps
Duplicate data
entry
Difficult to see
dependencies
Work completed in
order of receipt
Can’t spot
trends/issues
Inefficient
Delays
Difficult to
collaborate
Quality
assessments
Future study
decisions
Continuous
improvement

8. 8
A Unified Clinical Environment Improves Study Execution
Top drivers for unified clinical operations
Source: Veeva 2018 Unified Clinical Operations Survey
To the degree your organization needs to better integrate/unify the clinical applications identified in question 3 (e.g., CTMS, EDC, eTMF, etc.), what are the most important drivers? Select all that apply. (Q.5)
Percent of total respondents, N=180

9. 9
Requirements
Capabilities Cost Vendor
Relationship
Unified
Landscape
Collaboration
• Functionality
• Usability
• Performance
• Metrics
• Effort to configure
• Effort to integrate
• Industry expertise
• Vision and roadmap
• One log-in
• One view
• One experience
• Transparency
• Oversight
• Ease

10. 10
Why Vault Study Startup?
Capabilities Cost Vendor
Relationship
Unified
Landscape
Collaboration
• Flexible
• Configurable
• Realtime visibility
• Reduced system
resources
• Increased
productivity
• Proven track record
• Customer focused
• Streamline
operations
• Strategic fit
• Simplify
communications
• Better planning &
execution

11. Implementation Approach

12. 12
Implementation Approach: Guiding Principles
Keep it
Simple
Know Your
Audience
Keep the
Investigator
Experience
Top of Mind
Maintain
Open/Honest
Dialogue
Plan with the intent of long-term sustainability

13. 13
Implementation Approach: Five Key Areas Critical to Success
Implementation Team • Are the right resources identified?
• Is their time properly allocated?
Configuration • What technical & business process
changes are required?
Deployment • How will the capabilities be rolled out?
Training & Change Mgmt. • What is the training & communication
plan?
Leadership Support • Is the project actively and visibly
supported by senior leaders?

14. 14
Implementation Approach
Implementation
Team
Configuration
Deployment
Training and
Change Mgmt.
Leadership
Support
What about investigational sites?

15. 15
Factors Impacting Investigational Sites
Timing • Develop plan for awareness and onboarding
• Engage the sites as early as possible and begin WIIFM discussions
Training
• Be brief and concise
• Consider providing Quick Reference Card as a supplement
• Site-facing sponsor roles should familiarize themselves with site processes
Access • Determine which site staff roles will need system access
• Develop plan for how site users will be provisioned

16. 16
Factors Impacting Investigational Sites
Roles
• Who from the sites will have an action in the study start-up process?
• Who from the Sponsor will be the site’s primary contact throughout the
process?
Engagement
• Understand and communicate the value of site adoption
• Consider why sites might not adopt and factor into change management plans
• Will there be any sponsor check-in points to gather feedback?
Support • Develop support plan for site staff
• Proactively seek leadership team alignment on messaging and approach

17. 17
Anticipated Outcomes of a Successful Deployment
Success Criteria
ü Site adoption rate
ü # of support tickets logged
ü Types of questions
ü Sponsor/site user focus groups
ü Cycle time and metrics insights
ü Assessment of new processes
ü Implementation team experiences
ü Line manager and team feedback
Other Foundational Elements
ü Country configuration readiness
ü Support model
ü SOP and process change status
ü Integrations
Early deployment experiences will be used to make decisions on full deployment path

18. 18
Transformational Value
Sponsor of
Choice
Better Visibility &
Oversight
Harmonization &
Cross-Sector
Efficiency
Speed
Appreciating
Value

19. 19
Thank you!
Lisa Rakebrand
lrakebra@its.jnj.com