Learn the benefits of a unified clinical landscape, particularly how clinical trial management software (CTMS) and study start-up applications lead to more efficient trial management when working in concert with one another.

1. Efficient Trial Management
through Unified CTMS and
Study Start-up
•Webinar

2. 2Copyright © Veeva Systems 2018
Presented By
Henry Galio, Vault CTMS
Email: henry.galio@veeva.com
Ashley Davidson, Vault Study Startup
Email: ashley.davidson@veeva.com

3. 3Copyright © Veeva Systems 2018
Agenda
The State of Clinical Operations Technology State of Clinical Operations
When SSU and CTMS are Disconnected
The Value of Unified and Best-of-Breed
Q&A
1
2
3
4

4. The State of Clinical Operations
Technology

5. 5Copyright © 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
Hundreds of Tasks > Old Technologies >Complex and Inefficient Trial Process

6. 6Copyright © Veeva Systems 2018
Audience Poll
Challenges you face due to disconnected clinical technologies?
78% 73% 62% 54%
Watch on-demand webinar to gain full insights
http://go.veeva.com/ctms-ssu-xtalks

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

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. 9Copyright © Veeva Systems 2018
Integrated versus Unified
Content
Replicatio
n
DocumentMgmt.
Study
Planning
Site Activation
Study
Closeout
Data
Mgmt.
Site
Monitoring
• Disparate technologies & versions
• Multiple logins & user interfaces
• Disconnected data, documents, &
processes
• Limited visibility
Integrated
• One platform, one version
• One login & user experience
• Streamlined processes, seamless
flow of data & documents
• Full visibility
Unified

10. 10Copyright © 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

11. Integrated versus Unified
What’s the Difference?

12. 12Copyright © Veeva Systems 2018
Audience Poll
Is your CTMS and study start-up disconnected?
38% 20% 16% 16%
Watch on-demand webinar to gain full insights
http://go.veeva.com/ctms-ssu-xtalks

13. 13Copyright © Veeva Systems 2018
Disconnected Site Selection
Confirm and
Qualify
CMSEmail Survey Tool CTMS
10. Confirm site interest in
participation
11. Send CDA to site for
signature
12. Negotiate CDA changes
13. Search for existing CDA or
create new
14. Review and approve
internally
15. Route for signature
16. Upload fully executed CDA
17. Build feasibility
questionnaire
18. Distribute to interested
candidate sites
19. Review survey results
20. Track progress of site
qualification
21. Update site data, if
relevant, upon completed
questionnaire
22. Conduct PTAV
Score, Rank
and Select
CTMSMS Excel Email
23. Update candidate site list
24. Divide site list into tiers
25. Review scores/tiered sites
internally
26. Select site(s)
27. Update selection status in
CTMS
28. Notify site(s) of selection
29. Provide final site list to SSU
team to begin startup
activities
Measure Site
Performance
Investigator DBCTMS
30. Conduct SIV post-startup
31. Complete visit report
32. Review/approve report
33. Track enrollment progress –
planned vs. actual
34. Extract performance data
from CTMS
35. Import site data into DB
and other selection tools
Identify
Sites
CTMSInvestigator DB MS Excel Email
9 Review recommended/not
recommended lists with
internal team
1. Log into DB
2. Extract investigator and
institution data
3. Log into CTMS
4. Extract other site data
5 Import and compile all
relevant data
6. Review and clean site data
7. Search/Screen for prospects
8. Create candidate site list

14. 14Copyright © Veeva Systems 2018
Unified Site Selection
Confirm and
Qualify
CMSEmail Survey Tool CTMS
10. Confirm site interest in
participation
11. Send CDA to site for
signature
12. Negotiate CDA changes
13. Search for existing CDA or create
new
14. Review and approve
internally
15. Route for signature
16. Upload fully executed CDA
17. Build feasibility
questionnaire
18. Distribute to interested
candidate sites
19. Review survey results
20. Track progress of site
qualification
21. Update site data, if
relevant, upon completed
questionnaire
22. Conduct PTAV
Score, Rank
and Select
CTMSMS Excel Email
23. Update candidate site list
24. Divide site list into tiers
25. Review scores/tiered sites
internally
26. Select site(s)
27. Update selection status in
CTMS
28. Notify site(s) of selection
29. Provide final site list to SSU
team to begin startup activities
Measure Site
Performance
Investigator DBCTMS
30. Conduct SIV post-startup
31. Complete visit report
32. Review/approve report
33. Track enrollment progress
– planned vs. actual
34. Extract performance data from
CTMS
35. Import site data into DB and
other selection tools
Identify
Sites
CTMSInvestigator DB MS Excel Email
9 Review recommended/not
recommended lists with internal
team
1. Log into DB
2. Extract investigator and
institution data
3. Log into CTMS
4. Extract other site data
5 Import and compile all
relevant data
6. Review and clean site data
7. Search/Screen for prospects
8. Create candidate site list

15. 15Copyright © Veeva Systems 2018
Site Selection with Vault Clinical
Login to Vault Once
******
Unified Experience
• Streamlines site selection
by 30-40%
• Reduces number of
systems from 8 down to 3
• Shared data, content, &
workflows
• Endless loop of measured
site performance

16. 16Copyright © Veeva Systems 2018
Disconnected Site Initiation
MS ExcelEmail CTMS
4. Send package to SGL reviewer
5. Review & approve package
6. Notify SSU and/or CRA/Clin
Ops of approval
7. Open SSU Tracker
8. Input approved SGL date
9. Log into CTMS
10. Track GL approval date
SharePoint
1. Log into SharePoint system
2. Reconcile docs vs.
requirements for GL
3. Extract/download documents
Site
Greenlight
eTMFEmail
11. Compile approved GL
package with checklist
12. Send to TMF manager
13. Log into eTMF
14. Index/classify each document
15. Review each document for
quality/accuracy
16. File in correct location/section
MS Excel
17. Track eTMF filed date
TMF Filing
Email
18. Request anticipated GL
date from SSU team
19. Schedule SIV with study site
20. Confirm SIV with site
CTMS
21. Track scheduled SIV date
22. Track completion of pre-SIV
activities
23. Retrieve approved SGL docs
24. Conduct SIV
25. Prepare/Review visit report
MS Excel
27. Compile list of required
pre-SIV tasks & activities
28. Track completion of pre-SIV
activities
29. Track/log site training
LMS
26. Provide Protocol-specific
training (s) to site staffSite Initiation
Visit

17. 17Copyright © Veeva Systems 2018
Unified Site Initiation
MS ExcelEmail CTMS
4. Send package to SGL
reviewer
5. Review & approve package
6. Notify SSU and/or CRA/Clin
Ops of approval
7. Open SSU Tracker
8. Input approved SGL date
9. Log into CTMS
10. Track GL approval date
SharePoint
1. Log into SharePoint system
2. Reconcile docs vs.
requirements for GL
3. Extract/download documents
Site
Greenlight
eTMFEmail
11. Compile approved GL package
with checklist
12. Send to TMF manager
13. Log into eTMF
14. Index/classify each document
15. Review each document for
quality/accuracy
16. File in correct location/section
MS Excel
17. Track eTMF filed date
TMF Filing
Email
18. Request anticipated GL
date from SSU team
19. Schedule SIV with study site
20. Confirm SIV with site
CTMS
21. Track scheduled SIV date
22. Track completion of pre-SIV
activities
23. Retrieve approved SGL docs
24. Conduct SIV
25. Prepare/Review visit report
MS Excel
27. Compile list of required
pre-SIV tasks &
activities
28. Track completion of
pre-SIV activities
29. Track/log site training
LMS
26. Provide Protocol-specific
training (s) to site staffSite Initiation
Visit

18. 18Copyright © Veeva Systems 2018
Site Initiation with Vault Clinical
Login to Vault Once
******
Unified Experience
• Streamlines site greenlight
and initiation by 40-45%
• Reduces number of
systems from 6 down to 3
• Reduction of manual steps
• Visibility between start-up
and conduct processes

19. 19Copyright © 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

20. Best-of-Breed and Unified

21. 21Copyright © Veeva Systems 2018
The Best of Both Worlds
Best-of-Breed
Unified
Seamless user experience
Rapid innovation
Purpose-built functionality
Complete visibility and oversight
Unified data, documents, processes

22. 22Copyright © Veeva Systems 2018
Quality
Why Unified and Best-of-Breed?
InnovationVisibility CollaborationSpeed

23. 23Copyright © Veeva Systems 2018
Audience Poll
What other capabilities would be innovative in the study start-up
and trial management areas?
81% 60% 52% 52%
Watch on-demand webinar to get full insights
http://go.veeva.com/ctms-ssu-xtalks

24. Thank you

25. Watch Full Webinar
https://go.veeva.com/ctms-ssu-xtalks