This document discusses driving clinical trial efficiency through an outsourced model and moving towards a unified clinical model. It describes the current state of disparate clinical technologies and siloed processes that cause challenges. Moving to a unified model with one platform, one version, and streamlined data flow can provide benefits like improved visibility, oversight, decision making, and faster trial execution. Integrating applications and exposing electronic trial master files to partners can also boost collaboration. Leveraging data through reports and dashboards allows for ongoing monitoring and compliance.

1. Driving Clinical Trial Efficiency in an
Outsourced Model
Presenter: Shad Ayoub, Veeva
Outsourcing in Clinical Trials West Coast
February 13, 2019
Burlingame, CA

2. 2Copyright © Veeva Systems 2018
Objectives
Discuss today’s current state, challenges, and the
industry’s desire to move towards a unified clinical model
Discuss opportunities to transform trial execution through
greater collaboration
How to leverage data for oversight and compliance
Understand the difference between Integrated and
Unified

3. 3Copyright © Veeva Systems 2018
Clinical Trial Process Today
Study Planning and Set-Up
Site Activation
Monitoring and
Study Management
Data Management
Study Closeout
Document Management (TMF)
Site Activation
Tool
eTMF Tool
CTMS
CTMS
EDC

4. 4Copyright © Veeva Systems 2018
The Veeva Unified Clinical Operations Survey
examines the life sciences industry’s progress in
reducing system and process complexity to
improve study execution. This research aims to
understand the drivers, benefits, and barriers of a
unified clinical operating model.
Veeva Unified Clinical Operations Survey

5. 5Copyright © Veeva Systems 2018
Today’s Clinical Technology Landscape
Does your organization utilize applications developed by third-party vendors in
managing clinical studies? If yes, please indicate which are currently in use.
Source: Veeva 2018 Unified Clinical Survey, Q3
Percent of total respondents, N=331

6. 6Copyright © Veeva Systems 2018
Top Challenges Related to Application and Process Silos
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.
Source: Veeva 2018 Unified Clinical Survey, Q4
Percent of total respondents, N=331

7. 7Copyright © Veeva Systems 2018
87% of clinical leaders taking action to unify clinical systems and processes
Industrywide Move to A Unified Clinical Model
Source: Veeva 2018 Unified Clinical Survey, Q6
Percent of total respondents, N=331
Does your organization have an initiative underway to better integrate/unify
clinical applications in Q3?

8. 8Copyright © Veeva Systems 2018
Top Drivers for Unified Clinical Operations
Visibility and
Oversight
Faster Trials Study Quality Productivity Collaboration
77% 67% 62% 51% 49%
Source: 2018 Veeva Unified Clinical Operations Survey

9. Transform Trial Execution through
Collaboration

10. 10Copyright © Veeva Systems 2018
• Security
− Site users should only see content that applies to their site or has been directly shared with them
• Simplicity
− UI for sites should be a simple, secure means to exchange content
− Document re-use across multiple studies can reduce document collection needs
• Task-based Collaboration
− Site users usually interact with Sponsors/ CROs for upload/authoring and acknowledgement of
tasks
Expose Your eTMF to Partners
Site / Sponsor / CRO
Collaboration with eTMF

11. 11Copyright © Veeva Systems 2018
• Consistency
− Document exchange is performed the same regardless of the users involved
• Contemporaneousness
− Documents do not disappear into the void (e.g., email, fax, FedEx/UPS, local drive, etc.)
− Reports on completeness and timeliness are more accurate and meaningful
• Traceability of the Life of a Document
− All activity on a document in the eTMF is captured
• Reporting
− Ability to report on activities performed in the eTMF
Benefits
eTMF Collaboration

12. 12Copyright © Veeva Systems 2018
Passive vs. Active Operating Models
• Paper documents / scanning
• Study teams do not
regularly access the TMF
• TMF is not integrated with
other clinical systems
• No/few manual KPIs or
metrics
PASSIVE ACTIVE
• Electronic documents
managed in system
• Sites, CROs, and sponsor
have eTMF access
• TMF is integrated with other
eClinical systems
• Real-time KPIs and metrics
used for active management

13. Leverage Data for Oversight,
Compliance, and Decision-making

14. 14Copyright © Veeva Systems 2018
The sponsor should ensure oversight of any
trial-related duties and functions carried out
on its behalf, including trial-related duties and
functions that are subcontracted to another
party by the sponsor’s contracted CRO(s).
INTEGRATED ADDENDUM TO ICH E6(R1):
GUIDELINE FOR GOOD CLINICAL PRACTICE E6(R2), November 2016

15. 15Copyright © Veeva Systems 2018
The Power of Reports and Dashboards
• Reports and dashboards can be used as early as study planning and throughout the
life of a study
• Continuous visibility and better oversight of trial activities
Study
Administration
TMF
Planning
Document
Collection
Document
Processing
Closeout &
Archival

16. 16Copyright © Veeva Systems 2018
Historical Forward Looking Custom
How long did it take to approve
documents?
Which documents are approaching
expiration?
How long does it take to resolve
issues during Review?
How many documents have been
reviewed and approved?
Timeline Management
Where are the bottlenecks in a
process?
What is the duration documents
spent in each workflow?
TMF Completeness
How many iterations are needed
with each site prior to completion?
QC, Review, and Approval Cycle
Times
What items need attention?
E.g. Overdue Approvals
How many documents are in the
Approved State?
How many times has a specific user
viewed an approved document?
Inspection Readiness
What is the average time to
Approval?
What Can Reports / Dashboards Provide?

17. Integrated versus Unified
What’s the Difference?

18. 18Copyright © Veeva Systems 2018
Integrated versus Unified
Title Integrated Unified
Technology
Disparate technologies
Multiple versions
One platform
One version
User Experience
Different User Interfaces
Multiple Logins
One login
Unified experience
Data Flow
Disconnected processes
Broken flow of documents and data
Streamlined processes
Seamless flow of documents and data
Visibility Limited Complete

19. 19Copyright © Veeva Systems 2018
The Impact of Disparate Technologies
Higher Integration and
Maintenance Costs
Reduced Ability to Make
Quick Timely Decisions
Slow and Error-prone
Manual Processes

20. 20Copyright © Veeva Systems 2018
Interim Monitoring Visit Today

21. 21Copyright © Veeva Systems 2018
Interim Monitoring Visit With Unified Suite

22. 22Copyright © Veeva Systems 2018
Site
Activation
Monitor
&
Site Mgmt.
Data Mgmt.
Document
Mgmt.
Study
Planning
Study
Closeout
The Unified Clinical Trial Process
One
Unified Solution
One
Intuitive User
Experience
One
Complete View

23. Thank You
To read the 2018 Annual CRO Report visit:
http://bit.ly/AnnualCROReport18