J&J: Transforming Study Start-up in a Global Environment
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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.
J&J: Transforming Study Start-up in a Global Environment
- 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
- 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