The document discusses strategies for continuous improvement of clinical trial management systems (CTMS). It recommends establishing a change control board and defining enhancement processes to prioritize and manage system updates. Enhancement requests should be collected from various sources and assessed based on business needs, technical complexity, validation efforts, and impact on existing functionality. Enhancements should be prioritized and scheduled in regular releases to keep the system flexible without disrupting users. Continuous improvement ensures the CTMS meets evolving needs while maintaining stability.

1. Strategies for Continuous
CTMS Improvement
September 20, 2012
Parambir Singh
Vice President of
Clinical Trial Management Solutions
BioPharm Systems

2. 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

3. 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.

4. 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

5. 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?

6. 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

7. Establish Change Control Board
Change
Control
Board
Clinical
Administrator
Business
Representative
IT Project
Manager

8. 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:

9. Sources of Input
Enhancement
Request Log
Deferred
Requirements
User Feedback
Help Desk Log
Training
Feedback
Infrastructure
Roadmap
User
Community
Conference

10. Meetings & Frequency
• Meet with end users
• Review Help Desk Log
• Change Control Board
Meeting

11. 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

12. 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

13. Assess by Design/Development Complexity
• Level of effort required
• Custom coding needs
• Leverage in-house resources
• Fit with current system architecture
• Identify alternative approaches

14. Assess by Validation Effort
• Level of validation required
• Validation scenario complexity
• Regression testing needs

15. Assess by Impacted Modules and Upgrade Risks
• Impact on existing functionality
• Number of modules impacted
• Impact on existing integration
• Impact on future upgrades

16. 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)

17. 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

18. Demo: Defining scope of a point release

19. Summary: Continuous Improvement Process
Collect
enhancement list
Review, assess,
and prioritize
enhancement list
Determine scope
of project
Create change
control charter
Kickoff project

20. 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.

21. Thank you for attending!
Questions?

22. Contact Us
• North America Sales Contact:
– Rod Roderick
– rroderick@biopharm.com
– +1 877 654 0033
• Europe/Middle East/Africa Sales Contact:
– Rudolf Coetzee
– rcoetzee@biopharm.com
– +44 (0) 1865 910200
• General Inquiries:
– info@biopharm.com