Developing a Continuous Improvement Plan for Your Clinical and Safety Systems


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Developing a Continuous Improvement Plan for Your Clinical and Safety Systems

  1. 1. Developing a ContinuousImprovement Plan for YourClinical and Safety Systems November 5, 2012 Parambir Singh Vice President of Clinical Trial Management Solutions BioPharm Systems 1 PREVIOUS PREVIOUS NEXT NEXT
  2. 2. Welcome & IntroductionsParam SinghVice President of Clinical Trial Management SolutionsBioPharm 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. 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. 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. 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. 6. Establish Change Control Board Business Representative Clinical IT Project Administrator Manager Change Control Board 6 PREVIOUS PREVIOUS NEXT NEXT
  7. 7. Define Enhancement ProcessesDefine 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. 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. 9. Meetings & Frequency • Meet with end users • Review Help Desk Log • Change Control Board Meeting 9 PREVIOUS PREVIOUS NEXT NEXT
  10. 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. 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. 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. 13. Assess by Validation Effort• Level of validation required• Validation scenario complexity• Regression testing needs 13 PREVIOUS PREVIOUS NEXT NEXT
  14. 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. 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. 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. 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. 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. 19. Thank you for attending!Questions? 19 PREVIOUS PREVIOUS NEXT NEXT
  20. 20. 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: – 20 PREVIOUS PREVIOUS NEXT NEXT
  21. 21. Presenter – Param Singh• Contact – – +1 210 454 5192Param has been working in the life sciences industry hisentire career. As vice president of CTMS at BioPharm, hedeveloped the CTMS practice to become one of the best inthe industry.With a knack for resource and project management, Paramleads a highly skilled team of implementation specialists andcontinues to build lasting relationships with clients. 21 PREVIOUS PREVIOUS NEXT NEXT