Param Singh, Vice President of Clinical Trial Management Solutions, gave a presentation on the top 10 reasons why an organization needs a Clinical Trial Management System (CTMS). He began with introductions and an overview of his company's CTMS services. The top 10 reasons were then presented: 10) simpler maintenance than separate systems; 9) a centralized investigator database; 8) transparent financial tracking; 7) streamlined document tracking; 6) increased recruitment visibility; 5) ability to integrate with other systems; 4) greater compliance; 3) robust reporting; 2) informed decision-making; 1) scalable growth to manage more trials with fewer resources. The presentation concluded with a live poll for attendees to vote on desired CTMS feature demonstrations

1. Top 10 Reasons Why
You Need a CTMS
Param Singh

2. Welcome & Introductions
Param Singh
Vice President of
Clinical Trial Management Solutions
• 10+ years of experience
implementing Siebel Clinical
• Managed over a dozen Siebel Clinical
implementations

3. Welcome & Introductions
CTMS Practice Services
Implementation
Manage implementations
of Siebel Clinical, whether
custom builds or our
out-of-the-box
accelerator, ASCEND.
Integration
Build interfaces between
Siebel Clinical and other
clinical systems.
Training
Develop and/or deliver
standard and custom
training classes and
materials
Process Guidance
Provide insight, advice,
and solutions to specific
CTMS issues based on
industry best practices.

4. Today’s Agenda
Time (CDT) Topic
9:00-9:05 Welcome and Introductions
9:05-9:30 Count Down of Top 10 Reasons
Why You Need a CTMS
9:30-9:45 Live Demonstration of 2 Features,
Voted on by You
9:45-10:00 Q&A

5. Reason #10
Simpler Maintenance
Maintain one commercial system,
usually with support from the vendor,
rather than multiple spreadsheets
and/or home-grown databases.

6. Reason #10: Why?
• Minimal duplicate data entry and
error resolution
• No confusion about the stored
location or most current version
• No need to maintain expertise in
house; rely on vendor
– Vendor supplies updates, patches, and
bug fixes
• Hosting makes it even simpler; no
need to maintain IT infrastructure

7. Reason #9
Centralized Investigator Database
Store past, present, and future
investigator information in a central
location that can be
queried during
site selection.

8. Reason #9: Why?
• One master record with multiple
read-only “associations”
– People, organizations, and addresses are
stored separately and then associated to
one another as appropriate
• Centralized maintenance = cleaner
data
• Can capture additional metadata
from standardized dropdown lists
• Easier to query

9. Reason #8
Transparent Financial Tracking
Monitor planned costs vs. actual spend
vs. outstanding balances for
investigators, sites, sponsors, and
vendors.

10. Reason #8: Why?
• Investigator payments, IRB fees,
vendor expenses, etc. in one place
provides a comprehensive picture
• Enforces business rules and SOX
compliance through payment
statuses that can only be updated by
authorized users
• Helps to identify potential cost
savings and to plan better for future
trials

11. Reason #7
Streamlined Document Tracking
Create standardized lists of documents
to be collected over the course of
various types of trials, and track
standardized dates and
other information
against those lists.

12. Reason #7: Why?
• Enforces standardization and
consistency in the information
gathered and the method for
gathering it
• Allows users to update multiple
document records and/or fields
simultaneously
• Enables quick identification of
documents that are still outstanding,
expired, about to expire, etc.

13. Reason #6
Increased Recruitment Visibility
Track subject enrollment
across studies and
clinical programs
against planned targets.

14. Reason #6: Why?
• Identify high- vs. low-performing
investigators
• Learn which sites are experiencing
the greatest number of screen
failures and early terminations –
and why
• Capture metrics on planned vs.
actual recruitment
• Accurately plan monitoring resources

15. Reason #5
Ability to Integrate
Streamline processes even further
through automated interfaces
with other clinical
systems.

16. Reason #5: Why?
• One “source” system for each kind of
clinical data
• Fewer data entry/maintenance
resources needed
• Less data investigation and
correction needed
• No need to log into multiple systems
to find answers
• Processes are completed consistently
and quickly

17. Reason #4
Greater Compliance
Adhere to regulatory requirements and
guidelines through user access
controls, enforced processes, and
behind-the-scenes
tracking, such as
audit trails.

18. Reason #4: Why?
• Much easier to validate and keep
validated/controlled than
spreadsheets
• Much easier to control access:
system as a whole and specific
records
• Fewer deviations
• Greater data integrity
• Smoother audits

19. Reason #3
Robust Reporting
Answer questions quickly and easily
with ad hoc and canned reports
that query one
centralized database.

20. Reason #3: Why?
• Stores historical and current data
• Stores ALL clinical trial data, from
subject recruitment to vendor
payments to investigator information
• Offers high level and detailed
reporting capabilities
• Provides access to real-time data,
especially with integrations; no more
out-dated reports

21. Reason #2
Informed Decision-Making
Identify trends and inconsistencies
across investigators,
trials, and business
units.

22. Reason #2: Why?
• Real-time, comprehensive data
enables nimble, smart decision-
making
• Identify strengths and weaknesses
in PIs, vendors, and even your own
organization
• Identify areas of risk and put
processes in place to mitigate
• Make changes to current trials and
plan better for future trials

23. Reason #1
Scalable Growth
Increase the number and size of the
trials you manage with fewer additional
resources.

24. Reason #1: Why?
• No organization can afford to spend
exponentially to grow exponentially
• Scalable software solutions are the
answer
• CTMS consolidates and streamlines
subject tracking, investigator
payments, document tracking,
financial tracking, site monitoring,
and more, allowing you to manage
more and larger trials with less

25. Top 10 Reasons Why You
Need a CTMS
10. Simpler Maintenance
9. Centralized Investigator Database
8. Transparent Financial Tracking
7. Streamlined Document Tracking
6. Increased Recruitment Visibility
5. Ability to Integrate
4. Greater Compliance
3. Robust Reporting
2. Informed Decision-Making
1. Scalable Growth

26. Cast Your Vote!
Possible Choices:
• Clinical Administration - Study Setup
• Investigator Payments
• Protocol Expense Tracking
• Document Tracking and Document Packages
• Investigator Database
• Site Setup
• Site Management
• Subject Tracking and Recruitment Visibility
• SOP Compliance and Templates
• System Reporting

27. Siebel Clinical ASCEND

28. Q&A

29. Closing
Thank you for attending!
This webinar will be posted on
www.biopharm.com
within 24 hours
psingh@biopharm.com
+1 877-654-0033
+44 (0) 1865 910200