See slides from Veeva's Outsourcing Clinical Trials West Coast presentation. This deck explores the driving forces behind the industrywide move to streamline information exchange in clinical trials. Learn about modern technologies that improve how organizations work together across the clinical environment and discover new approaches to sharing trial information with study partners.

1. Steps to Overcome Information
Overload in Clinical Research
Shad Ayoub
Director, Clinical Strategy

2. 2Copyright © Veeva Systems 2020
Lessons Learned from EHR
Challenge shifting from digitizing to sharing
2009
EHR stimulus passed
(12% EHR adoption)
2015
96% EHR adoption
Medicare Access
and CHIP
Reauthorization
Act (MACRA)
2019
Apple allows any
health systems to
register directly2016
21st Century
Cures Act
Cancer
Moonshot 2020

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Growing focus on
rare diseases
Complex trial
designs
Stratified patient
populations
New Realities, New Pressures
Increased cost and complexity of running trials for all stakeholders

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Clinical Trials Take Longer than 10 Years Ago
A typical phase III protocol (means) 2001–2005 2011–2017 % increase
Total cycle time from site identification to FPI 25.6 weeks 29.1 weeks 14%
Time from patient visit to data entry 6.9 days 8.1 days 17%
Last patient last visit (LPLV) to database lock 33.4 days 36.1 days 8%
Source: Tufts CSDD

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The Industry Has Become Less Efficient Across R&D
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

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We’re Relying More on Partners
$38.3
$60.4
$71.6 $68.6
$10.4
$24.3
$43.1
$59.7
$5.9
$9.5
$12.7
$13.7
0
20
40
60
80
100
120
140
160
2000 2005 2010 2015
Internal Staff and Infrastructure CRO Services Investigative Site Services
Share of R&D Spending
Source: Tufts Center for the Study of Drug Development

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Clinical Trial Information Sharing
@
@
Sponsor
@
CRO 1
@
CRO 3
@
CRO 2
@
@
Site(s)
@
@
@

8. 8Copyright © Veeva Systems 2020
Sponsors Use Multiple Tools to Exchange Information with CROs
Email, portals, file share most common
What methods does your organization used to exchange trial data and documents with study partners? Select all that apply. (Q6)
Percentage of total sponsor respondents, N=346

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91%
84%
75% 74%
62% 60%
52%
39% 37%
25% 23%
10%
0%
10%
20%
30%
40%
50%
60%
70%
80%
90%
100%
EDC
eCRF
Portal
IVRS
Safety
CTM
S
ePRO
LM
S
eTM
FeSource
M
obile
ePRO
Other
Sites Smothered in Tech
What technology is provided by sponsors?
Source: CenterWatch 2016; (n=252 sites)
68%
18%
9%
5%
0%
10%
20%
30%
40%
50%
60%
70%
80%
90%
100%
Somewhat well Not very well Very well Not well at all
Sponsor provided tech meets your needs?
Low Value
Top down tech deployment strategies not meeting needs of sites

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Methods Used To Exchange Information with Sites
High use of paper shipments and email
What methods does your organization used to exchange trial data and documents with study partners? Select all that apply. (Q6)
Percentage of total respondents, N=461

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Challenges with Information Exchange
Biggest issues exchanging information with study partners
What are the biggest challenges, if any, your organization faces in utilizing the methods of information exchange identified in Q6? Select all that apply. (Q7)
Percentage of total respondents, N=461

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Modernizing clinical trials is an agency wide priority…
Efforts to streamline medical product development
can be frustrated by legacy business models that
discourage collaboration and data sharing, and the
adoption of disruptive technologies that make clinical
research more effective.
• - Statement by Former FDA Commissioner Scott Gottlieb, M.D.

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Opportunities to Create a Modern Clinical Network
From digitizing to sharing
Platforms vs. point solutions
Connected data
Standard DefinitionsTechnology Strategies Success Criteria
Domains of information
exchange
Measure extent to which
objective is met
Common language
Clarity
Consistency

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Unified Connected
High-Level Elements of a Technology Strategy
Purpose-Built

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Steady Adoption of eClinical Applications
Does your organization utilize applications developed by third-party vendors in managing clinical studies? If yes, please indicate which are currently in use. (Q.3)
Percent of total respondents, N=461
EDC, eTMF, RTSM, CTMS most common

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Unified Clinical Environment Improves Study Execution
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=461
Top drivers for unified clinical operations

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Challenges with Information Exchange
Biggest issues exchanging information with study partners
What are the biggest challenges, if any, your organization faces in utilizing the methods of information exchange identified in Q6? Select all that apply. (Q7)
Percentage of total respondents, N=461

18. 18Copyright © Veeva Systems 2020
Summary of Key Points
• Industry driven to modernize clinical research to speed
study execution
• Improving information exchange is becoming a top priority
• Opportunity remains to develop and adopt information
exchange standards and industry adoption success criteria

19. 19Copyright © Veeva Systems 2020
Veeva 2020 Unified Clinical Operations Survey
Help evaluate the industry’s progress to improve study execution
Complete the survey
and receive an Amazon gift card:
go.veeva.com/clinicalsurvey2020
Visit Veeva booth 38

20. Thank you