The document discusses the challenges and inefficiencies in the clinical trial process, highlighting increasing costs and extended timelines for drug approval. It presents the journey of Idorsia in adopting a unified platform to enhance clinical trial management, focusing on improved collaboration and data connectivity. The report emphasizes the potential advantages of moving from disconnected point solutions to a comprehensive, integrated system for better operational efficacy in clinical research.

1. It’s Never Too Late -
Improve Clinical Trial Processes
With a Unified Platform
February 28, 2019

2. 2Copyright © Veeva Systems 2019
Agenda
Industry Perspective – Challenges and Opportunities
1
Idorsia’s Journey to a Unified Solution
2
Summary
3
Q&A
4

3. Industry Perspective

4. 4Copyright © Veeva Systems 2019
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

5. 5Copyright © Veeva Systems 2019
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

6. 6Copyright © Veeva Systems 2019
Key Challenges
Silos Within Clinical
Silos Across Development
Increased Outsourcing
Process Inefficiency
Redundant Information
IT Burden
Usage Issues = Incompleteness
Redundancy = Poor Quality
Uninformed Decisions, Insights
Lack of Coordination and
Collaboration
Data Completeness and
Quality
Disconnected Point
Solutions

7. 7Copyright © Veeva Systems 2019
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=331
Today’s Clinical Trial Landscape
There has been an explosion of technology

8. 8Copyright © Veeva Systems 2019
What are the biggest challenges, if any, your organization faces in utilizing the clinical applications identified in question 3? (e.g., CTMS, EDC, eTMF, etc.) Select all that apply. (Q.4)
Percent of total respondents, N=331
But It’s Too Disconnected
Top challenges related to application and process silos

9. 9Copyright © Veeva Systems 2019
Monitoring
& Site
Mgmt.
Document
Mgmt.
Study
Closeout
Data Mgmt.
Study
Planning &
Setup
Site
Activation
And, It’s Proliferated …

10. 10Copyright © Veeva Systems 2019
Monitoring
& Site
Mgmt.
Document
Mgmt.
Study
Closeout
Data
Mgmt.
Study
Planning &
Setup
Site
Activation
… Throughout R&D
IDMP
Submissions
Planning
Regulatory
Intelligence
Study
Planning and
Setup
Registration
Tracking
Publishing
SOP Mgmt.
Training
CAPAs
Validation
Documents
Manufactured
Changes
Document
Mgmt.
Safety Report
Distribution
Signal
Detection
SAE Reporting
Case Intake
Case
Processing
Document
Mgmt.

11. 11Copyright © Veeva Systems 2019
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
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

12. 12Copyright © Veeva Systems 2019
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 by Tech
Which of the following tech, typically supplied by
sponsors, are currently used at site
Source: CenterWatch 2016; (n=252 sites)
0%
10%
20%
30%
40%
50%
60%
70%
80%
90%
100%
Somewhat well Not very well Very well Not well at all
Extent to which available tech solutions are meeting
site operating needs
Lots of different tech
pushed to sites from
sponsors
Most tech does not
support site’s
operational needs
Tech does not support site operations and lacks interoperability

13. 13Copyright © Veeva Systems 2019
Key Opportunities for Clinical Trials and Development
Platforms vs point solutions
Connected data
Cloud
Reimagine processes
Event-driven automation
Change and implementation
Shortening the distance
within clinical and R&D
Connecting ecosystem of
partners
CollaborationBetter ExecutionTechnology Simplification

14. 14Copyright © Veeva Systems 2019
Monitoring
& Site
Mgmt.
Document
Mgmt.
Study
Closeout
Data Mgmt.
Study
Planning &
Setup
Site
Activation
But How Do We Go From This…

15. 15Copyright © Veeva Systems 2019
Monitoring
& Site
Mgmt.
Document
Mgmt.
Study
Closeout
Data
Mgmt.
Study
Planning &
Setup
Site
Activation
And This…
IDMP
Submissions
Planning
Regulatory
Intelligence
Study
Planning and
Setup
Registration
Tracking
Publishing
SOP Mgmt.
Training
CAPAs
Validation
Documents
Manufactured
Changes
Document
Mgmt.
Safety Report
Distribution
Signal
Detection
SAE Reporting
Case Intake
Case
Processing
Document
Mgmt.

16. 16Copyright © Veeva Systems 2019
Sponsors
CROsSites
…To This?
UNIFIED &
CONNECTED

17. Journey to Simplifying the
Clinical Landscape

18. Idorsia Today
>750Highly qualified
professionals
10
>1 bn > 550State-of-the-art
laboratory workspaces
Compounds in the pipeline,
with four in late-stage
development
Swiss francs in cash
Improve clinical trial processes with unified platform | 28 Feb 201918
Multiple therapeutic areas
CNS
Cardiovascular
Immunological disorders
Orphan diseases

19. Legacy Systems Landscape
Idorsia
A “green field” with great time pressure and fixed deadline
Transition Agreements (12
months)
A Unique Opportunity
Project & Resource Management
Business & Corporate Systems
Infrastructure & User Support
eTMF CTMS
eCTDEDMS
EDC
Statistical
Computing
Environment
Data Analytics
QMS
Clinical Trial
Portal
Improve clinical trial processes with unified platform | 28 Feb 201919

20. Platform based and SaaS
The Strategy
Clinical & Quality Systems Scope
Document Management
Quality Management
Project & Resource Management
Clinical
Operations
Clinical
Data
Regulatory &
Submissions
CTMS & eTMF
QMS
EDMS
EDMS & eCTD
Functionality and Usability
• Best fit to Idorsia user requirements
• Minimal configuration no customization
• User-friendly and intuitive
• Connecting information in R&D
Idorsia‘s IT strategy
• One platform supporting a variety of functional areas
• True Software as a Service
• Compliant
Improve clinical trial processes with unified platform | 28 Feb 201920

21. Making the impossible happen
Our Journey’s Timeline and Scope
2017 2018 2019
J A S O N D J F M A M J J A S O N D J F M
Program & Change Management
Platform
CTMS & eTMF (Clinical)
EDMS (Regulatory & Quality)
QMS (Quality Management)
OtherClinical
eCTD System
Biometry Environment
Data Analytics Platform & Tools
Project & Resource Management System
Drug Safety Systems
Other
Business & Corporate Systems
Infrastructure & User Support
Kick-off WS to go-live Ongoing
Improve clinical trial processes with unified platform | 28 Feb 201921

22. A unified solution
Highlights and User Experience
Improve clinical trial processes with unified platform | 28 Feb 201922

23. CTMS
• 180 users
• 6 ongoing and all legacy
studies
eTMF
• 180 users
• 6 closed studies
EDMS
• 300 users
• 50.000 documents
Implementation & roll-out
Benefits Of The Unified Platform
Scope Highlights
Streamlined approach to validation documentation, testing, operational
procedures
Minimal integration effort
• Integrated eTMF/ CTMS, no technical interfaces required to align milestones
or transfer documents
• User provisioning/ SSO set up on platform level
Experience can be applied across all
applications
MAR
Improve clinical trial processes with unified platform | 28 Feb 201923

24. End User Experience
Benefits Of The Unified Platform
Highlights
Ease of use
• Same user interface and principles across all application
• Ease of navigation and search functionality (filters and views)
• Visual representation of documents and metadata in one view
Seamless use of CTMS and eTMF, e.g.
• Studies, sites, personnel only created once
• Monitoring Visit Reports signed in CTMS and automatically in eTMF
• Comprehensive progress reporting
Cross-linking of documents between
eTMF and EDMS
Clinical Trial Management System
(CTMS)
Electronic Trial Master File (eTMF)
Electronic Document Management
System (eEDMS)
Scope Highlights
Improve clinical trial processes with unified platform | 28 Feb 201924

25. Maintenance and Support
Benefits Of The Unified Platform
CTMS/ eTMF
• 310 users
• 14 ongoing studies
(w/o phase 1)
EDMS
• 300 users
Reduced training effort
• Users get quickly up to speed if trained on one of the Vaults
• CRAs - 3 hours, Study Managers - 2.5 hours (eTMF and CTMS)
Small support team working across the platform
Streamlined release management
• 3 major releases per year which can be run “silent”
• New functionality implemented at own pace
per application
Streamlined vendor and contract management
HighlightsScope
Improve clinical trial processes with unified platform | 28 Feb 201925

26. • Strong dependency on one vendor requires solid risk assessment and a strategic partnership
• Not all applications may be “best of breed”
• Software as a service / cloud based
- To be in line with the corporate IT strategy
- Requires streamlined business processes adapted to the system to avoid customization
Improve clinical trial processes with unified platform | 28 Feb 201926
Considerations!!

27. Document Management
Quality Management
Project & Resource Management
Clinical
Operations
Clinical
Data
Regulatory &
Submissions
CTMS & eTMF
QMS
EDMS
EDMS & eCTD
Summary
User Experience
Implementation & Roll-out
Maintenance & Support
Improve clinical trial processes with unified platform | 28 Feb 201927

28. Questions

29. Thank You
For more information, please contact:
Jim.Reilly@Veeva.com
LinkedIn: www.linkedin.com/in/jim-reilly