Learn how a modern CTMS leads to better oversight, study analytics, and risk identification. This presentation also covers common barriers to the migration process and how to overcome them. Watch a demonstration of Veeva Vault CTMS: http://bit.ly/VaultCTMSDemo

1. Speed Clinical Trials from Start to Close
The Path to a Modern CTMS

2. Senior Director, Vault CTMS
Henry Galio

3. 3Copyright © Veeva Systems 2019
Clinical Studies Are Getting More Complex
Trial volume and complexity are increasing at exponential rates
-100,000
-50,000
0
50,000
100,000
150,000
200,000
250,000
300,000
350,000
# of Trials
# of Trials Linear (# of Trials)
• Increase in:
• Outsourcing
• Number of studies
• Number of amendments
• Complexity
• Data sources
• Volume of data
• Need for collaboration
Clinical Trials Take Longer to Execute than 10 Years Ago

4. 4Copyright © Veeva Systems 2019
We Have Become Less Efficient Despite Technology
79%
81%
84%
88%
1980 1990 2000 2010
Percentage of All Drugs Entering Clinical
Testing that Fail to Receive Approval
Capitalized Cost of Drug Development
$1,044B
$2,558B
2003 2018
• 26% Direct Costs
• 18% Time-based
• 56% Cost of Failure
Source: Tufts CSDD Source: EvaluatePharma; William Blair & Wells Fargo Securities

5. Audience Poll #1

6. 6Copyright © Veeva Systems 2019

7. 7Copyright © Veeva Systems 2019

8. 8Copyright © Veeva Systems 2019
Legacy CTMS Applications Are Not Built For Today’s Trial
Aggregation Layer
CTMS
QMSeTMF$$$$
SSULABELS
LIMSeSource
EDC
Integration Layer
OpsData
ReportingDashboards, Analytics Dashboards, Analytics

9. 9Copyright © Veeva Systems 2019
Key Challenges of Legacy Applications
Productivity and Process
• Duplicative efforts and siloed
processes causes inefficiencies
• Ineffective coordination causes
trial delays
System Maintenance
• Maintenance and upgrade
issues burden IT
• Integration challenges result in
poor data quality
Visibility and Compliance
• Lack of insight leads to
uninformed decisions
• Lack of oversight may result in
non-compliance
Business Tip:
Audit active tracking spreadsheets.
Illustrate the information hand-offs
between teams and time it takes to
enter information in multiple places.
Business Tip:
Quantify the time and costs IT teams
spend on updates. How many times
does an unexpected event impact
productivity during an upgrade?
Business Tip:
List risks introduced with manual
processes and the resulting lack of
visibility. Identify what metrics can’t
be tracked due to data siloes.

10. 10Copyright © Veeva Systems 2019
A Different Approach to “Platform”
Acquire and Integrate Strategy
Hard for Vendors Hard on Users
DocumentMgmt.
Study
Planning
Site Activation
StudyCloseout
Data
Mgmt.
Site
Monitoring
• Multiple, distinct technologies
• Multiple dev cycles
• Multiple teams
• Focus on maintaining, not innovating
• Struggle to meet commitments
• Multiple log-ins and experiences
• Not usually best of breed
• Limited data flow
• Poor visibility
• Disconnected processes
• Hard to get clean data out

11. 11Copyright © Veeva Systems 2019
• Multiple, distinct technologies
• Multiple user log-ins and experiences
• Disconnected data, document, and processes
• Limited visibility
Integrated versus Unified
Integrated
• One technology; single version
• One login and experience
• Unified workflow, reporting and process
• Seamless flow of study data and documents
• Full visibility
Unified
Content
Replicatio
n
DocumentMgmt.
Study
Planning
Site Activation
Study
Closeout
Data
Mgmt.
Site
Monitoring

12. 12Copyright © Veeva Systems 2019
Indicated the
need for CTMS
improvement
Nearly
100%
Indicated the
desire to move
to unification
87%
• Visibility and
oversight
• Proactive risk
identification
• Better study
analytics
Top
Drivers
Industrywide Move Toward Unified Clinical

13. 13Copyright © Veeva Systems 2019
Attributes of a Modern CTMS
Command Center
• A place to truly manage a trial
• Reduced clicks, log ins, transactions,
more actionable insights
• Point-to-click configuration
Improve Monitoring
• Improve monitoring efficiency through
reduced data entry and user demands
• Event-driven automation
• Risk-based everything approach
Actionable with EDC
• Direct connectivity from trip report
to subject record
• EDC-agnostic
Pace of Innovation
Oversight Built-in
• ICH E6 (R2) compliant oversight capabilities
• Closed-loop issue management; track SLAs
• Robust oversight reporting & dashboards
• Multiple releases per year
• New features for changing
business requirements
Unified and Collaborative
• Unified with eTMF and SSU
• Shared data and content
• Tell the operational story of a trial
• Drive action and collaboration

14. 14Copyright © Veeva Systems 2019
Example: Interim Monitoring Visit Process
Using Existing CTMS Technology (29 Steps)

15. 15Copyright © Veeva Systems 2019
Example: Interim Monitoring Visit Process
Using Unified Clinical Operations Cloud (8 Steps)
CRA logs in once *******
CTMS
eTMF
Study Start-up
Access to a unified environment
Prepare for IMV
Request updates and
documents
Prepare and send visit
confirmation letter
Conduct visit, including
SDV
Auto-generate MVR
Review and annotate
MVR
Approve MVR report MVR auto-filed in eTMF
1 2 3 4
5 6 7 8

16. 16Copyright © Veeva Systems 2019
CTMS Modernization Case Study #1
A Large European Biotech Company
Business Challenges Business Objectives
• Spinoff from a large global Biopharma
• Implement a complete clinical, regulatory,
and quality platform in less than 12 months
• Change management challenges due to
system changes
• Cloud first
• Easy to use functionality
• Integrated platform-based solutions
…we needed cutting-edge cloud technology that could scale as we
grow.” “…This solution met all three objectives within a very tight
timeline.

17. 17Copyright © Veeva Systems 2019
CTMS Modernization Case Study #2
A Top 20 Biopharma Company
Business Challenges Business Objectives
• Disconnected clinical operations resulted in
a number of workarounds
• Lots of manual and localized solutions for
end users
• High complexity with lots of duplicate work
• Unified approach of applications to talk to
one another driving faster more informed
decisions
• Unified and seamless user interface
• Ability to reimagine and automate tasks
To reimagine the way we work required a Unified Clinical Platform that
improves efficiency and accelerates our ability to provide best science
to our patients.

18. Audience Poll #2

19. 19Copyright © Veeva Systems 2019

20. 20Copyright © Veeva Systems 2019

21. 21Copyright © Veeva Systems 2019
Implementation Accelerators
True Multi-tenant
Cloud
Configurability Ease-of-Use Rapid Innovation Single Platform
Immediately
available
environment, only
one version in
production
No need for
customization
Click to configure
Graphical workflows
and reporting
Pre-validated IQ and
PQ by release
Agile cloud
methodology
A suite of unified
clinical operations
applications (CTMS,
eTMF, SSU)
50% - 80% faster implementations compared to legacy market leading CTMS

22. 22Copyright © Veeva Systems 2019
Data Migration Accelerators
Automated
Loader
Restful Web
Services
Data Loader
Templates
Easy to migrate and
load data
Simple, Scalable, and
powerful
Loading easy enough
for business to use
Study start-up or eTMF customers already have most of the CTMS data loaded in their platform

23. 23Copyright © Veeva Systems 2019
Integration Accelerators
Easy to use APIs Backward
compatibility
Documentation Platform-level
Integrations
Offline integration
Simple and easy to
use APIs
APIs are backward
compatible
(unbreakable)
Well documented
and freely available
Integration at the
cloud platform level
not the application
level
Offline integration
with a partner’s
technology in a week
A unified approach dramatically reduces the number of integrations

24. 24Copyright © Veeva Systems 2019
Clinical Cloud is Still the Minority
Aggregation Layer
CTMS
QMSeTMF$$$$
SSU
LABELS
LIMSeSource
EDC
Integration Layer
Op
s
Dat
a
ReportingDashboards, Analytics Dashboards, Analytics
On Premise
21.6%
Aggregation Layer
CTMS
QMSeTMF$$$$
SSU
LABELS
LIMSeSource
EDC
Integration Layer
Op
s
Dat
a
ReportingDashboards, Analytics Dashboards, Analytics
Web-hosted
59%
Aggregation Layer
CTMS
QMSeTMF$$$$
SSU
LABELS
LIMSeSource
EDC
Integration Layer
Op
s
Dat
a
ReportingDashboards, Analytics Dashboards, Analytics
Cloud
19.4%
Multi-tenant Cloud
Unified
eTMF, CTMS,
SSU, QMS, EDC,
eSource
Source: Annual Reports, SEC Filings, Investor Presentations, Press Releases, Journals, Articles, ClinicalTrials.gov, the World Bank, International Federation of Pharmaceutical
Manufacturers & Associations, U.S. Food and Drug Administration, National Institutes of Health, National Cancer Institute, Eurostat - European Commission, the EU
Industrial R&D Investment Scoreboard, Expert Interviews, and Markets and Markets Analysis.

25. 25Copyright © Veeva Systems 2019
Not All Clouds are Created Equal
Application
Data / Documents
Runtime
Middleware
OS
Virtualization
Servers
Storage
Networking
Packaged Software
On Premise
Application
Data / Documents
Runtime
Middleware
OS
Virtualization
Servers
Storage
Networking
Application
Data / Documents
Runtime
Middleware
OS
Virtualization
Servers
Storage
Networking
Infrastructure
(As a Service)
Application
Data / Documents
Runtime
Middleware
OS
Virtualization
Servers
Storage
Networking
Managed by You Managed by the Vendor
Platform
(As a Service)
Software
(As a Service)

26. 26Copyright © Veeva Systems 2019
Does Your CTMS Pass the Cloud Litmus Test?
Configuration vs.
Customization?
Single-instance only one
version, multi-tenant?
Upgrades and updates are
included?
Integrations carry
forward?
Native cloud?Rapid implementation?
Predictable costs vs.
hidden fee’s?

27. 27Copyright © Veeva Systems 2019
Benefits of CTMS Cloud
IT Business
• True, single source of truth
• Familiar modern consumer web user
interface across processes
• Access anytime, anywhere, on any device
• Dramatically faster access to information
• Dramatically reduced user training and
training documentation across user base
• Increased global system adoption and
compliance
• SaaS platform always remains current
• Innovation provided via 3 releases per year
• Built to scale and perform
• Pre-validated with IQ and OQ included
• Consistent system administration
• Industry best practices based delivered
applications speeds implementation
• Modern configuration ability allows true
business change over time

28. 28Copyright © Veeva Systems 2019
Examples of Modern CTMS Value Realization
Productivity Levers Realized Value
Monitoring Efficiencies
- 50% reduced effort to write reports
- Site essential docs, SDV data instantly available
Issue Management
5% savings in effort for issue management (includes taking action
on non-enrolling sites, CAPA management, QI reporting)
Internal Delivery Model
(Streamlined Workflow)
Time saved via streamlined workflows would allow 10% more
studies to be delivered
Automatic Monitoring Deliverable Filing Eliminate manual filing in eTMF from CTMS
Ease of Sponsor Visibility Direct sponsor access
Comprehensive Study and Site Level
Data Quality & Reporting
Reduction of run costs; reduction of data clean-up and customer
remediation cycles
Clean, Centrally Accessible Operational Data Referential database for RFPs
Site Communication Reduce cost and effort to communicate with sites

29. 29Copyright © Veeva Systems 2019
Speed Trial Management with Modern CTMS
Greater Visibility
and Oversight
Proactive Risk
Identification
Better Study
Analytics
• Implement a remote monitoring strategy to reduce number of site visits
• Easy to use role-based dashboards and streamlined navigation
• Monitor subject enrollment against goals, proactively address delays
• Enable proactive closed-loop issue management
• Manage end-to-end trial process, get a global view of tasks & milestones
• Get actionable insights from easy, self-serve reports and dashboards
Faster Clinical
Trials
• Document and identify trends on site adherence to ICH/GCP guidelines
• Accurate, real-time view of trial information across all study partners

30. 30Copyright © Veeva Systems 2019
Call to Action
Replace your
20+ year old
CTMS
Be a skeptic,
question your
vendors
Demand more
and expect
more
Say no to
integrated
platforms,
demand
unification

31. Thank you

32. Henry Galio
Senior Director, Vault CTMS
610-509-8957
Henry.galio@veeva.com

33. 33Copyright © Veeva Systems 2019
• Enable faster trials
• Improve decision making
• Streamline clinical operations
Watch a demonstration
http://bit.ly/VaultCTMSDemo