Strategies for ContinuousCTMS ImprovementSeptember 20, 2012Parambir SinghVice President ofClinical Trial Management SolutionsBioPharm Systems
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’sLabPas 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 & IntroductionsCTMS Practice ServicesImplementationsManage implementations of SiebelClinical, Siebel Clinical ASCEND, andOracle Health Sciences LabPas.IntegrationsBuild interfaces between SiebelClinical or LabPas and other clinicaland non-clinical systems.TrainingDevelop and/or deliver standard andcustom training classes and materials.Process GuidanceProvide insight, advice, and solutionsto specific clinical trial managementissues.
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 upWHAT 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 potentialenhancements• Increases system acceptance and usability
Establish Change Control BoardChangeControlBoardClinicalAdministratorBusinessRepresentativeIT ProjectManager
Define Enhancement ProcessesWhen to roll out theenhancementsHow to manage andprioritize enhancementsHow often to meet andreview enhancementsHow to collectenhancementsDefine the following in your plan:
Sources of InputEnhancementRequest LogDeferredRequirementsUser FeedbackHelp Desk LogTrainingFeedbackInfrastructureRoadmapUserCommunityConference
Meetings & Frequency• Meet with end users• Review Help Desk Log• Change Control BoardMeeting
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 theenhancement
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 themfrom 1 to 10, and with no two items sharing the same ranking (allunique)
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 asintegration
Best Practices for Continuous Improvement Plans• Start thinking of the plan prior to the initial go-live• Schedule recurring meetings to establish the continuousimprovement process• After initial release, ensure users have a chance to use thesystem and understand its functionality before planningany additional releases• Note: The continuous improvement process can also resultin non-system changes, such as training material updates,business process re-engineering, etc.