strategies for continuous ctms improvement
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Strategies for Continuous CTMS Improvement
September 20, 2012 Parambir Singh Vice President of Clinical Trial Management Solutions BioPharm Systems
Welcome & Introductions
Param Singh Vice President of Clinical Trial Management Solutions BioPharm Systems, Inc.
• CTMS practice director since 2007 – Expertise in managing all phases and styles of clinical trials
– Leads the team that implements, supports, and enhances Oracle’s LabPas and Siebel Clinical solutions
• Extensive Siebel Clinical implementation experience – 11+ years of experience implementing Siebel Clinical
– 15+ implementations
– Spearheaded the creation of the Siebel Clinical “accelerator” ASCEND
Welcome & Introductions
CTMS Practice Services
Implementations Manage implementations of Siebel Clinical, Siebel Clinical ASCEND, and Oracle Health Sciences LabPas.
Integrations Build interfaces between Siebel Clinical or LabPas and other clinical and non-clinical systems.
Training Develop and/or deliver standard and custom training classes and materials.
Process Guidance Provide insight, advice, and solutions to specific clinical trial management issues.
Agenda
• Importance of a Continuous Improvement Plan – Establish Change Control Board
– Define Enhancement Processes
• Sources of Input – Meetings & Frequency
• How to Manage Enhancements
• How to Prioritize Enhancements
• When to Make Enhancements
• Best Practices for Continuous Improvement Plans
• Q&A
Common Scenario
• Just completed the initial system implementation
• End users are trained, but not yet in the system
• Not all desired requirements included in the initial release
• May potentially roll out the system to other business units
• The annual project budget meeting is coming up
WHAT TO DO NEXT?
Importance of a Continuous Improvement Plan
• Bridges the gap for post production support
• Less anxious end users
• Helps focus on business critical requirements
• Encourages end user communication and feedback
• Allows system to be flexible if business process changes
• Establishes an objective way to evaluate potential
enhancements
• Increases system acceptance and usability
Establish Change Control Board
Change Control Board
Clinical Administrator
Business Representative
IT Project Manager
Define Enhancement Processes
When to roll out the enhancements
How to manage and prioritize enhancements
How often to meet and review enhancements
How to collect enhancements
Define the following in your plan:
Sources of Input
Enhancement Request Log
Deferred Requirements
User Feedback
Help Desk Log
Training Feedback
Infrastructure Roadmap
User Community Conference
Meetings & Frequency
• Meet with end users
• Review Help Desk Log
• Change Control Board Meeting
How to Manage Enhancements
• Use a spreadsheet to track requests
• Categorize each request as an enhancement or defect
• Assess each request from different perspectives
– Business operation criticality
– Design/development complexity
– Validation effort
– Impacted modules and upgrade risks
Assess by Business Operation Criticality
• Identify business requestor
• Capture clear business request details
• Provide justification for enhancement
• Determine impact on daily operations
• Identify potential alternatives/workarounds
• Capture request date
• Capture requestor’s initial priority ranking on the
enhancement
Assess by Design/Development Complexity
• Level of effort required
• Custom coding needs
• Leverage in-house resources
• Fit with current system architecture
• Identify alternative approaches
Assess by Validation Effort
• Level of validation required
• Validation scenario complexity
• Regression testing needs
Assess by Impacted Modules and Upgrade Risks
• Impact on existing functionality
• Number of modules impacted
• Impact on existing integration
• Impact on future upgrades
How to Prioritize Enhancements
• Provide business justification
• All business units should evaluate
• Rank requirements by level of importance
– High / Medium / Low
– Numerical
• For example, in a 10 item enhancement list, ask users to rank them
from 1 to 10, and with no two items sharing the same ranking (all
unique)
When to Make Enhancements
• Initial Enhancements
– At least 3 months after the initial release
– Provide end users an opportunity to get familiar with the system
– Provides time to gather and refine list of enhancements
• Subsequent Releases
– Depend on budget available
– May have minor releases every 3 or 6 months
– Can roll the enhancements in with a major release such as
integration
Demo: Defining scope of a point release
Summary: Continuous Improvement Process
Collect enhancement list
Review, assess, and prioritize
enhancement list
Determine scope of project
Create change control charter
Kickoff project
Best Practices for Continuous Improvement Plans
• Start thinking of the plan prior to the initial go-live
• Schedule recurring meetings to establish the continuous
improvement process
• After initial release, ensure users have a chance to use the
system and understand its functionality before planning
any additional releases
• Note: The continuous improvement process can also result
in non-system changes, such as training material updates,
business process re-engineering, etc.
Thank you for attending!
Questions?
Contact Us
• North America Sales Contact:
– Rod Roderick
– +1 877 654 0033
• Europe/Middle East/Africa Sales Contact:
– Rudolf Coetzee
– +44 (0) 1865 910200
• General Inquiries: