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Extracting Actionable Intelligence from Clinical Trials
- 1. 1Beyond Automation:Extracting ActionableIntelligence from Clinical TrialsTevin Pathareddy Fred Landry
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- 3. Outline How wework today: Impacts and Challenges
- 4. Holistic approachto CT management
- 5. Aligning your organizationthrough BPM
- 6. Feeding yourbusiness brain with BI
- 7. Putting SharePointto value added use
- 8. A reallife SP example: IMP Shipment Authorization
- 9. Rolling knowledge intodashboards3
- 10. How we worktoday4Information and procedural silosIn today’s GxP landscape we have independent sets of:
- 11. Resources (Individuals, groupsand organizations)
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- 13. Departments or organizationspecific processes
- 14. All generate dataand information which for the most part remains dislocated and underexploited
- 15. This makes ourworking environment inefficient, clumsy (as opposed to agile) and costlyThe silos effect: Lack of operational knowledge5The Silos Symptoms:Limited cross system/cross functional knowledge
- 16. NVA transcribing, reconcilingand collating data
- 17. Unclear study progressat any one point in time becoming even murkier across programs of studies
- 18. Under exploitation ofoperational data
- 19. Opposing sets ofmetrics and KPIs across functions
- 20. System redundanciesThe Challenge6Intoday’s R&D environment, we strive to:
- 21. Make better drugdevelopment decisions
- 22. Accelerate time tomarket
- 23. Increase organizational efficiencyand agility
- 24. Improve understanding andmanagement of R&D processes
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- 28. Improve complianceMeeting theChallenge…7To meet the challenge we must break down organizational and procedural silos by:
- 29. Leveraging new technologiesand work methods
- 30. Map out, re-engineer,automate and integrate processes
- 31. Leverage and establishprocedural and data standards
- 32. Integrate computerized systemsand data sources
- 33. Identify clear andmeasurable metrics and KPIs
- 34. Align and integratethe quality system with automated processesDefinition of BPM8Business process management (BPM) is a management approach focused on aligning all aspects of an organization
- 35. It is aholistic management approach that promotes business effectiveness and efficiency while striving for innovation, flexibility, and integration with technology
- 36. Is based oncontinuous improvement of processesSource: Wikipedia
- 37. BPM technology elements9Dashboards
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- 41. Sites andSub-Sites
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- 45. SharePoint controlled librariesand workspacesDefinition of Business Intelligence10In 1958 Hans Peter Luhn, a computer scientist at IBM used the term business intelligence for the first time. He defined intelligence as: "the ability to apprehend the interrelationships of presented facts in such a way as to guide action towards a desired goal."
- 46. Definition of BI11BIBIrefers to skills, processes, technologies, applications and practices used to support decision making
- 47. BI technologies providehistorical, current, and predictive views of business operations
- 48. BI is composedon reports, dashboards, metrics and analytical models
- 49. BI is capableof transforming operational and business data into information and knowledgeBI Implementation12Top Critical Success Factors are:Business driven methodology & project management
- 50. Clear vision &planning
- 51. Committed management support& sponsorship
- 52. Data management &quality issues
- 53. Mapping the solutionsto the user requirements
- 54. Performance considerations ofthe BI system
- 55. Robust & extensibleframework Source: Naveen K Vodapalli, 2009
- 56. Mapping out processes– High level to detailed13We typically think of clinical trial organization as hierarchical
- 57. Processes usuallyalign to a particular level of hierarchy
- 58. Processes can behigh level and then drill downIdentifying milestones and KPI14Milestones are predefined events within a process or processes
- 59. Milestonescorrespond to predefinedkey events or values within the various levels of the process maps
- 60. Examples of Milestoneswould be:
- 61. IND Submission (MoleculeLevel)
- 62. Protocol Approval (StudyLevel)
- 63. FSFV (Site Level)ProcessMaps15
- 64. Identifying milestones andKPIs with process maps16KPIs are key operational indicators which are measured using information from processes, data, documents
- 65. KPIs are calculatedor non-calculated values based on one or many datapoints
- 66. KPIs can bedrilled in to see underlying KPIs and data or rolled-up to see higher level KPIs (they are hierarchal)
- 67. Examples of KPIswould be:
- 68. Time between FSFVand DB Lock (study level)
- 69. Time between lastquery and DB lock (study level)
- 70. Time to queryresolution (study, site level)Identifying milestones and KPIs with process maps17
- 71. Identify data sourcesand integration points18Data sources for KPIs and Milestones can come from:
- 72. Documents and documentmetadata
- 73. Procedures and proceduraldata (workflows)
- 74. Databases (EDC, CTMS,Safety etc.)
- 75. Project plans andmanual metrics
- 76. When thinking aboutdata for KPIs and Milestones, it is important to identify unique data sources
- 77. Establishment and useof standards is key to be able to integrate data sources and proceduresIntegrating Processes through BPM19
- 78. Building an operationalknowledge model20Dashboards – roll-up, drill-down, drill-inBy identifying key metrics, milestones and indicators at all levels we are able to develop multi-dimensional dashboards
- 79. These dashboards allowup to move up and down in our operational knowledge
- 80. By adding athird dimension we are able to drill in both in terms of data but also time
- 81. This model enablesus to pin point key factors which have positive/negative impacts on our operations Aligning with the QMS21Implementing this approach often requires changes to components of the QMS
- 82. When re-engineering processesbreak them down into clear steps, tasks, responsibilities and deliverable elements
- 83. Adopt and useavailable standards to define your metrics, KPIs and processes. (UML, BPMN, CDISC, etc.)
- 84. Clearly identify allinterconnections on process maps
- 85. Re-engineer manual processesinto automated processes
- 86. Finally align theseelements to your BPM and collaborative environmentIdentifying milestones and KPIs with process maps22
- 87. Study Level ProcessBreak Down (Site Management)23
- 88. Site Level ProcessBreakdown (Site Initiation)24
- 89. Site Level Sub-ProcessBreakdown (IMP Management)25
- 90. IMP Authorization ProcessDependencies26
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- 92. System Design Process(MSSharePoint)SOPs28
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- 94. BI Example UsingOut of the Box SharePoint Tools30Excel ServicesKPIDashboardFormsWorkflowsLists / LibrariesSource: Microsoft
- 95. IMP Shipment AuthorizationWorkflow31
- 96. Clinical Operations DocumentLibrary32
- 97. New IMP ShipmentAuthorization Request InfoPath Form33From CTMSFrom SharePoint Library
- 98. New IMP ShipmentAuthorization Request in Forms Library34
- 99. IMP Shipment RequestApproved by Clinical Operations (Form)35
- 100. IMP Shipment RequestApproved by Clinical Operations (Library)36
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- 103. IMP Shipment AuthorizationDashboards39
- 104. Clinical Study Management– Milestones and KPIs40Time to Initiation Time to SiteClosureCTACDASQVSIVFSFVLSLVDB Lock DateSCVIRB ApprovalCTM shippedISF SentISF CompleteIRB SubmissionCTM Shipment Authorization
- 105. Clinical Study Management– the “Big Picture”41
- 106. Clinical Study ManagementScorecard – Study level42
- 107. Clinical Study ManagementScorecard – Region level43
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- 109. Recommended approach45Map outR&D process maps; remember top-down approachIdentify processes (SOPs) and interactions for each level and stepIdentify people and organizations who intervene in each process and stepIdentify data sourcesIdentify key metrics, milestones and KPIsIdentify technology elementsDefine a scope for pilot projectImplement and improve
- 110. BPMGAMP 5 (IssueManagement, CAPA, etc.)ISOICHCDISCObject Management Group [BPMN, UML, etc.] (www.omg.com)BIMetrics Champion (www.metricschampion.org )Some BPM/Standards and Resources46
- 111. [email protected]. 514-223-9153 ext.[email protected]. 514-223-9153 ext. 213Contact Info47