1. Developing a Continuous
Improvement Plan for Your
Clinical and Safety Systems
November 5, 2012
Parambir Singh
Vice President of
Clinical Trial Management Solutions
BioPharm Systems
1 PREVIOUS
PREVIOUS NEXT
NEXT

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
2 PREVIOUS
PREVIOUS NEXT
NEXT

3. 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
3 PREVIOUS
PREVIOUS NEXT
NEXT

4. 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?
4 PREVIOUS
PREVIOUS NEXT
NEXT

5. 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
5 PREVIOUS
PREVIOUS NEXT
NEXT

6. Establish Change Control Board
Business
Representative
Clinical IT Project
Administrator Manager
Change
Control
Board
6 PREVIOUS
PREVIOUS NEXT
NEXT

7. Define Enhancement Processes
Define the following in your plan:
When to roll out the
enhancements
How to manage and
prioritize enhancements
How often to meet and
review enhancements
How to collect
enhancements
7 PREVIOUS
PREVIOUS NEXT
NEXT

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

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

10. 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
10 PREVIOUS
PREVIOUS NEXT
NEXT

11. 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
11 PREVIOUS
PREVIOUS NEXT
NEXT

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

13. Assess by Validation Effort
• Level of validation required
• Validation scenario complexity
• Regression testing needs
13 PREVIOUS
PREVIOUS NEXT
NEXT

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

15. 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)
15 PREVIOUS
PREVIOUS NEXT
NEXT

16. 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
16 PREVIOUS
PREVIOUS NEXT
NEXT

17. Continuous Improvement Process
Collect
enhancement list
Review, assess,
Kickoff project and prioritize
enhancement list
Create change Determine scope
control charter of project
17 PREVIOUS
PREVIOUS NEXT
NEXT

18. 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.
18 PREVIOUS
PREVIOUS NEXT
NEXT

19. Thank you for attending!
Questions?
19 PREVIOUS
PREVIOUS NEXT
NEXT

20. 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
20 PREVIOUS
PREVIOUS NEXT
NEXT

21. Presenter – Param Singh
• Contact
– psingh@biopharm.com
– +1 210 454 5192
Param has been working in the life sciences industry his
entire career. As vice president of CTMS at BioPharm, he
developed the CTMS practice to become one of the best in
the industry.
With a knack for resource and project management, Param
leads a highly skilled team of implementation specialists and
continues to build lasting relationships with clients.
21 PREVIOUS
PREVIOUS NEXT
NEXT