A clinical trial management system (CTMS) can be a real lifesaver when it comes to managing studies. But the implementation process can be a huge headache if not handled well. Don’t let that headache happen to you! Perficient’s Param Singh, director of clinical trial management solutions, discussed three approaches to implementing a CTMS. He covered the pros and cons of each approach, as well as what factors to consider when choosing the right approach for your organization.

1. 3 WAYS TO IMPLEMENT A
CLINICAL TRIAL MANAGEMENT SYSTEM

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ABOUT PERFICIENT
Perficient is a leading information
technology consulting firm serving
clients throughout North America.
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.

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Founded in 1997
Public, NASDAQ: PRFT
2014 revenue $456.7 million
Major market locations:
Allentown, Atlanta, Ann Arbor, Boston, Charlotte,
Chicago, Cincinnati, Columbus, Dallas, Denver,
Detroit, Fairfax, Houston, Indianapolis, Lafayette,
Milwaukee, Minneapolis, New York City, Northern
California, Oxford (UK), Southern California,
St. Louis, Toronto
Global delivery centers in China and India
>2,600 colleagues
Dedicated solution practices
~90% repeat business rate
Alliance partnerships with major technology vendors
Multiple vendor/industry technology and growth awards
PERFICIENT
PROFILE

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Business Process
Management
Customer Relationship
Management
Enterprise Performance
Management
Enterprise Information
Solutions
Enterprise Resource
Planning
Experience Design
Portal / Collaboration
Content Management
Information Management
Mobile
BUSINESSSOLUTIONS
50+PARTNERS
Safety / PV
Clinical Data
Management
Electronic Data Capture
Medical Coding
Clinical Data
Warehousing
Clinical Data Analytics
Clinical Trial
Management
Healthcare Data
Warehousing
Healthcare Analytics
CLINICAL/HEALTHCAREIT
Consulting
Implementation
Integration
Migration
Upgrade
Managed Services
Private Cloud Hosting
Validation
Study Setup
Project Management
Application Development
Software Licensing
Application Support
Staff Augmentation
Training
SERVICES
OUR SOLUTIONS PORTFOLIO

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AGENDA
Topic
Welcome and Introduction
CTMS Implementation Methodologies
Methodology Pros and Cons
Case Study
Q&A

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WELCOME & INTRODUCTION
Param Singh
Director of Clinical Trial Management Solutions
Life Sciences, Perficient
CTMS practice lead since 2008
– Leads the team that implements, supports, enhances, and
integrates Siebel Clinical
Extensive Siebel Clinical implementation experience
– 15+ years of experience implementing Siebel Clinical
– 30+ implementations and integrations
– Spearheaded the creation of ASCEND, an official Oracle Accelerate
solution for Siebel Clinical

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3 CTMS IMPLEMENTATION METHODOLOGIES
Big Bang Rolling Release Modular

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BIG BANG
• Project incorporates all requirements for the CTMS, including
integration, automation, and system functionality
• Phases include analysis, design, test/validation and deployment
• All project requirements are identified during analysis and documents
are signed off sequentially

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ROLLING RELEASE
• Project divided into iterations
• Each iteration includes analysis, design, test and potentially
deployment. With rolling releases, the goal is to go live/release with
each iteration
• Ideally governed by one validation plan

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MODULAR
• System implemented quickly using out-of-the-box functionality
• Enable modules slowly over time to larger user group, as adoption rate
and core business allows

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BIG BANG PROS AND CONS
• The time span between analysis and deployment can be high if there
are many requirements, including configuration, integration and
reports. This leads to changing requirements and delayed timelines.
• The stakeholders/users have little to no visibility into the application
design until it is completely designed and implemented. Rework is
often required since expectations may have been different.
• Project failure rate is higher with this methodology.
• Business can’t reap the benefits of the system until deployment,
therefore ROI is delayed.
• Change management can be difficult when releasing a new system
and revised processes all at once, and to a larger user community.

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CASE STUDY – BIG BANG
Business Need
• New CTMS to be implemented
• Enhancements needed to support core business requirements
• Key integrations needed to eliminate dual data entry
Implementation Approach
• Big Bang
– 12+ month project to implement all requirements with a large implementation team
– Additional involvement/resource commitment needed from client business and IT organization
Benefits Realized / Challenges
• Went live with system after 12+ months
– Users were trained at the end of the implementation on entire system
– Core functionality, integrations, and enhancements started to be used immediately
– Multiple workstreams in parallel, so more coordination needed along the way
– Change management and communication workstreams were crucial to keep business engaged
and excited about new system
– CTM process was completely revamped with new system, in depth training was needed on
system and process/SOPs
– Larger transformation/change to manage
– Less appetite for additional changes in subsequent releases

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ROLLING RELEASE PROS AND CONS
• System is implemented during each iteration and demos to the
business can take place after each iteration to further tweak the future
design of the system, if needed.
• Likelihood of changes being needed after release is slim because
stakeholders are engaged throughout the process.
• It is easier to adopt a new system and associated processes in
smaller chunks.
• ROI is achieved sooner because high priority requirements are
implemented and released sooner.

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CASE STUDY- ROLLING RELEASE
Business Need
• New CTMS to be implemented
• Enhanced Payments Module for unique business process
• EDC integration with CTMS
Implementation Approach
• Rolling Release
– 1st workstream: Base ASCEND Accelerator implementation
– 2nd workstream: Payments Module release, along with additional enhancements
– 3rd workstream: Trip Report Module release, along with EDC Integration
Benefits Realized
• Went live with base system in about 8 weeks
– Users were trained and using the system very quickly
– Core functionality started to be used immediately
• Subsequent workstreams
– Release of additional functionality was timed, with resources scheduled to ensure user adoption
– Able to manage change according to the ability of the user community
– Gives time for users to get familiar with system before introducing additional complexity and
automation, etc.

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MODULAR PROS AND CONS
• System is implemented very quickly, with the included functionality of
all modules.
• Can be done with OOTB system or with the use of a trusted, validated
“accelerator” solution.
• Focus on modules that relate to core business functions, and enable
other modules as user community are ready for them.
• ROI is achieved very quickly with an OOTB implementation.
• Additional functionality can be released in real-time, since it is an
administrative change to enable additional modules.
• Can still move forward with enhancements using rolling release
methodology.

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CASE STUDY- MODULAR RELEASE
Business Need
• New CTMS to be implemented
• No integrations needed immediately
• Smaller user community looking for immediate benefits of a centralized system
Implementation Approach
• Modular Release
– Base ASCEND Accelerator implementation
Benefits Realized
• Went live with base system in about 8 weeks
– Only enabled key modules in first phase via administration
– Limited core functionality started to be used immediately
• Subsequent workstreams
– Able to manage change according to the ability of the user community via administration of
system – No additional development, IT, consulting costs
– Gives time for users to get familiar with system before introducing additional modules via
administration of system
– Training was focused on only modules that were enabled
– System does not overwhelm users with complexity

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QUESTIONS?

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For more information, please contact:
Param.Singh@perficient.com
LifeSciencesInfo@perficient.com (Sales)
+1 877 654 0033 (U.S. Sales)
+1 303 570 8464 (U.S. Sales)
+44 (0) 1865 910200 (U.K. Sales)
THANK YOU
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