The document outlines GSK's transformation strategy for study start-up, emphasizing the integration of people, processes, and technology to improve efficiency and standardization. It discusses the implementation of a unified clinical ecosystem and collaborative solutions to streamline operations while addressing challenges in current processes. Key takeaways include the importance of change management, alignment across business units, and a focus on user experience to ensure successful system adoption.

1. Preparing the
Business for
Study Start-up
Change
Jess Robinson
Director, Study Start-up

2. Agenda
1
2
3
Introduction
Compelling reasons to transform study start-up
People, Process, and Technology
The pillars that drive change
Results
What GSK has achieved with Vault Study Startup
4 Q&A
Get your questions answered

4. GSK’s Unified Technology Journey
Build the capabilities
of our people
Improve the user experience for all
personnel involved
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2
Become a more efficient organisation
to support faster timelines
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5
4
Drive standardisation across business
units supporting a global process change
Unified Clinical eco-system with single entry
point, workflows, and complete view
people process technology
Integrated Reporting allows AI and Machine
Learning with improved data quality
Clinical Vault Programme: Collection of current clinical operations projects joined
together to extract maximum value for GSK. Using Tech solutions as the catalyst to align.

5. people process technologyprocess

6. Opportunities to Improve Key Processes
• Data and functionality
across disparate systems
• Little visibility to roadblocks
• Process delays due to
inefficient technology
• Mixed model for
accountabilities
• Siloed ways of working
• Six methods + email
• Manual collection
SITE DOCUMENT EXCHANGE REG/ETHICS SUBMISSIONS SITE GREENLIGHT
6
  

7. Unified solution: align processes to demonstrate value
Process Changes Affected the Rollout Approach
• Documents from Study
Start-up go directly to eTMF
• Integration from Vault to
drug release system
• Consider interactions
between RIM, eTMF, and
Study Startup
• Shared responsibility
across country users
• Manage rollout across
two Vaults/cross-links
• Focus on site
relationships and
experience – become
sponsor of choice
• Tech solutions as
catalyst to align
SITE DOCUMENT EXCHANGE REG/ETHICS SUBMISSIONS SITE GREENLIGHT
7

8. people process technologytechnology

9. Balancing the risk of new system implementation and study delivery
Our Phased Approach to Rollout
MEET THE TEAM
• Core team: Business &
Tech
• Designated Ambassadors
• Became SMEs and
helped build the
system
• Train the trainers
• Every country has
POC to handhold
– PHASE I
– (Initially two phases, combined into one)
– 20 countries
• Implemented as many countries as possible to ensure consistency across
studies (most countries use Vault Study Startup)
• Extended country intel period to pressure test
Deployed site document exchange to ready the business
(large-scale change that impacts entire business)
– PHASE II
– 10 countries
SYSTEM GO-LIVE: JULY 2020
INTERIM
PHASE
9

10. Cross-Vault team assignment and Governance
Vault Study Startup Learnings
10
Designate people who understand the business and impacts across
applications to ensure changes in one system don’t affect another (milestones)
Work with TMF teams to understand milestone configurations
Establish a steering committee who can make decisions that impact both
eTMF and Study Startup
Define a central group who is responsible for all Vaults to eliminate siloed
decision-making and manage access rights

11. people process technologypeople

12. Change management tactics
Preparing the Business
12
&
Include end users
from the start
Identify strategic
change champions
Enable agility with the
right team structure
&

13. GSK’s Unified Study Start-up Journey Results
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people process technology
• Introduced Global Study
Start-up Team
• Cultural shift: data-driven
decision-making, metrics and
KPIs, strong ambition
• Alignment across business
units for simplification
• Focus on what regulations
are required rather than
tweaking original processes
• Inherently siloed – tech needs
to support, not complicate
• Decisions to meet needs of
end user – simplification and
efficiency

14. Key Takeaways
14
Account for cross-
Vault implications
when making
decisions
Structure team to
drive alignment and
agile decisions
Start-up tech should
support people and
processes
Dedicate time to
change management
to increase adoption

15. Q&A