3 ways to implement a clinical trial management system
TRANSCRIPT
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
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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 SinghDirector 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 BANGBusiness 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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