Gone are the days of using spreadsheets to manage clinical trials. Fortunately, a clinical trial management system (CTMS) such as Oracle Siebel CTMS, offers an effective method for streamlining business processes, reducing cost and saving time. Whether you are a sponsor running global trials or a research organization conducting hundreds of studies, Perficient’s Param Singh, Director of Clinical Trial Management Solutions, will teach you: What a CTMS is and who needs one Key functions of a CTMS CTMS selection process System types and implementation options Best practices

1. The ABCs of Clinical Trial Management Systems
Param Singh, Director of Clinical Trial Management Solutions
Life Sciences Business Unit
facebook.com/perficient linkedin.com/company/perficient twitter.com/perficient_LS

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. About Perficient
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.

4. Perficient Profile
• 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

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

6. Life Sciences Practices / Solutions
Deep Clinical and Pharmacovigilance Applications Expertise
Implementation
Migration
Integration
Validation
Consulting
Upgrades
Managed Services
Application Development
Private Cloud Hosting
Application Support
Sub-licensing
Study Setup
Services
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 / EmpiricaTrace
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 Topic
1:00‐1:05 Welcome and Introduction
1:05‐1:15 What is a CTMS and Who Needs One
1:15‐1:25 Key Functions of a CTMS
1:25‐1:30 CTMS Selection Process
1:30‐1:35 System Types & Implementation Options
1:35‐1:45 Best Practices
1:45‐2:00 Q&A

9. What is a CTMS?
• Web-based technology solution that centralizes
the management aspects of clinical trials
• Results in streamlined business processes and
reduced time and cost for most trials
• Enables informed decision-making based on real-time
data
• Simplifies historical reporting

10. Who Needs a CTMS?
• Any sponsor organization, clinical research
organization or academic medical center that:
– Manages multiple clinical trials on an ongoing basis
– Wants to centralize and standardize the management of
clinical trials and the associated business processes
– Wants to reduce study start-up time and associated costs
while increasing efficiencies

11. Key Functions of a CTMS
• Investigator and Site Database
– Cataloging the history and details
of all individuals and organizations
associated with clinical trials
– Accelerating feasibility analyses
during investigator and site selection
• Study Set-Up
– Tracking essential documents
– Planning for study expenses
– Standardizing visit and payment schedules

12. Key Functions of a CTMS
• Site Management
– Tracking of site budgets and investigator payments
– Tracking of subject enrollment and progression
– Tracking of investigational product and ancillary supplies
– Tracking of protocol deviations and follow-up issues
– Tracking of site visits and monitoring reports

13. Key Functions of a CTMS
• Subject Tracking
– Tracking overall subject enrollment
– Tracking individual subject visits and activities
– Tracking subject status at any time
• Document Tracking
– Tracking regulatory and other documents based on a study, site,
individual or company
– Tracking single documents or document packages

14. Key Functions of a CTMS
• Financial Tracking
– Monitoring expenses across a project
– Tracking investigator payments based on completed activities or
milestones
– Tracking pass-through expenses at the site or study level
• Reporting
– Monitoring trip reports
– Document tracking reports
– Payment reports

15. Selecting a CTMS
• Requirements
– Organization gathers requirements from business users, IT and
other stakeholders
– Requirements are reviewed, finalized and prioritized
• Demos
– Vendor RFPs are distributed and responses received
– Demos are scheduled by multiple vendors
– Gap analyses are performed
– Short list of best-fit systems is developed
• Final Selection
– Following further demos, additional requirement reviews and
detailed sales discussions

16. Consideration: System Types
• Standard CTMS:
– Out-of-the-box system without
organization-specific customizations
– Shorter implementation time, but may not meet all of the
organization’s requirements
• CTMS Accelerator:
– Pre-configured version of a standard CTMS that includes
commonly-requested configurations and enhanced
functionality
– Can satisfy many of the organization’s key requirements
without additional development
– Less time and cost than a customized system

17. Consideration: System Types
• Customized CTMS:
– Standard or accelerator system
that is tailored to organization
specific configurations and/or
enhancements
– Implementations can be up to and over several months
– Costs can be up to and over $1M, depending on the system
chosen and level of customization
• Costs can be reduced by starting with an accelerator

18. Consideration: Implementation Options
• In-House:
– Hardware and software is owned, housed and operated by the
organization and maintained by its IT department
• Hosted:
– Hardware and software is housed and maintained off-site by a third
party

19. Consideration: Hosting Options
• Dedicated Hosting:
– You own the software and the servers, but the servers are
housed/maintained by a data center
• Shared Hosting:
– You own the software, but the servers are owned, housed,
maintained by a data center and can be shared by others
• Cloud Computing/SaaS:
– You lease the use of the software and servers

20. Best Practices: Selection Process
• Collect requirements from ALL stakeholders
• Consider requirements beyond system functionality
• Prioritize and define your evaluation scale
– Consider whether you need all requirements met immediately or
whether some can wait for a future phase

21. Best Practices: Implementation Strategy
• “Big Bang”
– All aspects of implementation
completed simultaneously
• Phased
– Implementation is broken up into chunks, such as:
Basic Installation
Point Release for
Custom
Configurations
Data Migration &
Retirement of
Legacy Systems
Integrations

22. Best Practices: Before Implementation
• Assemble your project team
• Determine the tasks,
deliverables, deadlines
and responsible resources
• Create a scope control plan
• Design your communication plan
• Begin your SOP gap analysis
• Begin analyzing the
organizational structure

23. Best Practices: During Implementation
• Adhere to the project charter and the
communication plan
• Design your rollout plan
• Design your training plan
• Design your support plan
• Involve users early and often
• Create a “data standards” document
• Mandate the use of CTMS

24. Questions?

25. Thank You!
For more information, please contact:
Param.Singh@perficient.com
LifeSciencesInfo@perficient.com (Sales)
+1 303 570 8464 (U.S. Sales)
+44 (0) 1865 910200 (U.K. Sales)
www.perficient.com
www.facebook.com/perficient
www.twitter.com/perficient_LS