Sponsors and research organizations are often tasked with building a business case for a clinical trial management system (CTMS) before they even evaluate the various solutions in the marketplace. After multiple successful Oracle Siebel CTMS implementations, Perficient has identified 10 ways you can benefit from a CTMS solution. In this slideshare we share information that you can leverage as you develop a business case for a CTMS. We also demonstrate the two most popular CTMS benefits and corresponding features.

1. 10 Things to Consider When Building a
CTMS Business Case
Param Singh, Director of Clinical Trial Management Solutions
Life Sciences Business Unit
facebook.com/perficient twitter.com/perficient_LSlinkedin.com/company/perficient

2. Welcome & Introduction
Param Singh
Director of Clinical Trial Management Solutions
Life Sciences, Perficient
• CTMS practice head since 2008
– Leads the team that implements, supports, enhances and
integrates Oracle’s CTMS solution
• Extensive Siebel CTMS implementation experience
– 14+ years of experience implementing Siebel CTMS
– 30+ implementations and integrations
– Spearheaded the creation of ASCEND, an official Oracle Accelerate
Solution for Siebel CTMS

3. Perficient is a leading information technology consulting firm serving clients throughout
North America and Europe.
We help clients implement business-driven technology solutions that integrate business
processes, improve worker productivity, increase customer loyalty and create a more agile
enterprise to better respond to new business opportunities.
About Perficient

4. • Founded in 1997
• Public, NASDAQ: PRFT
• 2013 revenue ~$373 million
• Major market locations throughout North America
• Atlanta, Boston, Charlotte, Chicago, Cincinnati, Cleveland,
Columbus, Dallas, Denver, Detroit, Fairfax, Houston,
Indianapolis, Los Angeles, Minneapolis, New Orleans, New
York City, Northern California, Philadelphia, Southern
California, St. Louis, Toronto and Washington, D.C.
• Global delivery centers in China, Europe and India
• >2,100 colleagues
• Dedicated solution practices
• ~85% repeat business rate
• Alliance partnerships with major technology vendors
• Multiple vendor/industry technology and growth awards
Perficient Profile

5. BUSINESS SOLUTIONS
Business Intelligence
Business Process Management
Customer Experience and CRM
Enterprise Performance Management
Enterprise Resource Planning
Experience Design (XD)
Management Consulting
TECHNOLOGY SOLUTIONS
Business Integration/SOA
Cloud Services
Commerce
Content Management
Custom Application Development
Education
Information Management
Mobile Platforms
Platform Integration
Portal & Social
Our Solutions Expertise

6. Life SciencesPractices/Solutions
Implementation
Migration
Integration
Validation
Consulting
Upgrades
Managed Services
Application Development
Private Cloud Hosting
Application Support
Sub-licensing
Study Setup
Services
Deep Clinical and Pharmacovigilance Applications Expertise
Clinical Trial
Management
Clinical Trial Planning and Budgeting
Oracle ClearTrial
CTMS
Oracle Siebel CTMS / ASCEND
Mobile CRA
Clinical Data Management
& Electronic Data Capture
CDMS
Oracle Clinical
Electronic Data Capture
Oracle Remote Data Capture
Oracle InForm
Medical Coding
Oracle Thesaurus Management System
Safety &
Pharmacovigilance
Adverse Event Reporting
Oracle Argus Safety Suite
Oracle AERS / Empirica Trace
Axway Synchrony Gateway
Signal Management
Oracle Empirica Signal/Topics
Medical Coding
Oracle Thesaurus Management System
Clinical Data
Warehousing & Analytics
Clinical Data Warehousing
Oracle Life Sciences Data Hub
Clinical Data Analytics
Oracle Clinical Development Analytics
JReview
Data Review and Cleansing
Oracle Data Management Workbench
Clients

7. Welcome & Introductions
CTMS Practice Services
Implementation
Manage implementations of
Siebel CTMS/ASCEND and
Mobile CRA.
Integration
Build interfaces between
Siebel CTMS and other
clinical and safety systems.
Training
Develop and/or deliver
standard and custom training
classes and materials.
Process Guidance
Provide insight, advice and
solutions for specific CTMS
issues based on industry
best practices.

8. Today’s Agenda
Time (ET) Topic
11:00‐11:05 Welcome and Introduction
11:05‐11:30 Count Down of Top 10 Things to
Consider When Building a CTMS
Business Case
11:30‐11:45 Live Demonstration of 2 Features, Voted
on by You
11:45‐12:00 Q&A

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

10. Consideration #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

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

12. Consideration #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

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

14. Consideration #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

15. Consideration #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

16. Consideration #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.

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

18. Consideration #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

19. Consideration #5
Ability to Integrate
Streamline processes even further through
automated interfaces
with other clinical and safety
systems

20. Consideration #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

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

22. Consideration #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

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

24. Consideration #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

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

26. Consideration #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

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

28. Consideration #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

29. Top 10 Considerations
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

30. Siebel Clinical ASCEND

31. 31

32. www.facebook.com/perficient
www.perficient.com
www.twitter.com/perficient_LS
Thank You!
For more information, please contact:
Param.Singh@perficient.com
LifeSciencesInfo@perficient.com (Sales)
+44 (0) 1865 910200 (U.K. Sales)
+1 877 654 0033 (U.S. Sales)