1<br />Beyond Automation:<br />Extracting Actionable Intelligence from Clinical Trials<br />Tevin Pathareddy <br />Fred La...
Introduction<br />2<br />
Outline<br /><ul><li> How we work today: Impacts and Challenges
 Holistic approach to CT management
Aligning your organization through BPM
 Feeding your business brain with BI
 Putting SharePoint to value added use
 A real life SP example: IMP Shipment Authorization
Rolling knowledge into dashboards</li></ul>3<br />
How we work today<br />4<br />Information and procedural silos<br /><ul><li>In today’s GxP landscape we have independent s...
Resources (Individuals, groups and organizations)
Computerized systems
Departments or organization specific processes
All generate data and information which for the most part remains dislocated and underexploited
This makes our working environment inefficient, clumsy (as opposed to agile) and costly</li></li></ul><li>The silos effect...
NVA transcribing, reconciling and collating data
Unclear study progress at any one point in time becoming even murkier across programs of studies
Under exploitation of operational data
Opposing sets of metrics and KPIs across functions
System redundancies</li></li></ul><li>The Challenge<br />6<br /><ul><li>In today’s R&D environment, we strive to:
Make better drug development decisions
Accelerate time to market
Increase organizational efficiency and agility
Improve understanding and management of  R&D processes
Reduce cost
Reduce risk
Improve quality
Improve compliance</li></li></ul><li>Meeting the Challenge…<br />7<br /><ul><li>To meet the challenge we must break down o...
Leveraging new technologies and work methods
Map out, re-engineer, automate and integrate processes
Leverage and establish procedural and data standards
Integrate computerized systems and data sources
Identify clear and measurable metrics and KPIs
Align and integrate the quality system with automated processes</li></li></ul><li>Definition of BPM<br />8<br /><ul><li>Bu...
It is a holistic management approach that promotes business effectiveness and efficiency while striving for innovation, fl...
Is based on continuous improvement of processes</li></ul>Source: Wikipedia<br />
BPM technology elements<br />9<br /><ul><li> Dashboards
 Excel services
 Performance Point
Workflows
 Sites and Sub-Sites
 Task lists
 Calendars
 Blogs
SharePoint controlled libraries and workspaces</li></li></ul><li>Definition of Business Intelligence<br />10<br />In 1958 ...
Definition of BI<br />11<br />BI<br /><ul><li>BI refers to skills, processes, technologies, applications and practices use...
BI technologies provide historical, current, and predictive views of business operations
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Extracting Actionable Intelligence from Clinical Trials

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Extracting Actionable Intelligence from Clinical Trials

  1. 1. 1<br />Beyond Automation:<br />Extracting Actionable Intelligence from Clinical Trials<br />Tevin Pathareddy <br />Fred Landry<br />
  2. 2. Introduction<br />2<br />
  3. 3. Outline<br /><ul><li> How we work today: Impacts and Challenges
  4. 4. Holistic approach to CT management
  5. 5. Aligning your organization through BPM
  6. 6. Feeding your business brain with BI
  7. 7. Putting SharePoint to value added use
  8. 8. A real life SP example: IMP Shipment Authorization
  9. 9. Rolling knowledge into dashboards</li></ul>3<br />
  10. 10. How we work today<br />4<br />Information and procedural silos<br /><ul><li>In today’s GxP landscape we have independent sets of:
  11. 11. Resources (Individuals, groups and organizations)
  12. 12. Computerized systems
  13. 13. Departments or organization specific processes
  14. 14. All generate data and information which for the most part remains dislocated and underexploited
  15. 15. This makes our working environment inefficient, clumsy (as opposed to agile) and costly</li></li></ul><li>The silos effect: Lack of operational knowledge<br />5<br />The Silos Symptoms:<br /><ul><li>Limited cross system/cross functional knowledge
  16. 16. NVA transcribing, reconciling and collating data
  17. 17. Unclear study progress at any one point in time becoming even murkier across programs of studies
  18. 18. Under exploitation of operational data
  19. 19. Opposing sets of metrics and KPIs across functions
  20. 20. System redundancies</li></li></ul><li>The Challenge<br />6<br /><ul><li>In today’s R&D environment, we strive to:
  21. 21. Make better drug development decisions
  22. 22. Accelerate time to market
  23. 23. Increase organizational efficiency and agility
  24. 24. Improve understanding and management of R&D processes
  25. 25. Reduce cost
  26. 26. Reduce risk
  27. 27. Improve quality
  28. 28. Improve compliance</li></li></ul><li>Meeting the Challenge…<br />7<br /><ul><li>To meet the challenge we must break down organizational and procedural silos by:
  29. 29. Leveraging new technologies and work methods
  30. 30. Map out, re-engineer, automate and integrate processes
  31. 31. Leverage and establish procedural and data standards
  32. 32. Integrate computerized systems and data sources
  33. 33. Identify clear and measurable metrics and KPIs
  34. 34. Align and integrate the quality system with automated processes</li></li></ul><li>Definition of BPM<br />8<br /><ul><li>Business process management (BPM) is a management approach focused on aligning all aspects of an organization
  35. 35. It is a holistic management approach that promotes business effectiveness and efficiency while striving for innovation, flexibility, and integration with technology
  36. 36. Is based on continuous improvement of processes</li></ul>Source: Wikipedia<br />
  37. 37. BPM technology elements<br />9<br /><ul><li> Dashboards
  38. 38. Excel services
  39. 39. Performance Point
  40. 40. Workflows
  41. 41. Sites and Sub-Sites
  42. 42. Task lists
  43. 43. Calendars
  44. 44. Blogs
  45. 45. SharePoint controlled libraries and workspaces</li></li></ul><li>Definition of Business Intelligence<br />10<br />In 1958 Hans Peter Luhn, a computer scientist at IBM used the term business intelligence for the first time. He defined intelligence as: <br />"the ability to apprehend the interrelationships of presented facts in such a way as to guide action towards a desired goal."<br />
  46. 46. Definition of BI<br />11<br />BI<br /><ul><li>BI refers to skills, processes, technologies, applications and practices used to support decision making
  47. 47. BI technologies provide historical, current, and predictive views of business operations
  48. 48. BI is composed on reports, dashboards, metrics and analytical models
  49. 49. BI is capable of transforming operational and business data into information and knowledge</li></li></ul><li>BI Implementation<br />12<br />Top Critical Success Factors are:<br /><ul><li>Business driven methodology & project management
  50. 50. Clear vision & planning
  51. 51. Committed management support & sponsorship
  52. 52. Data management & quality issues
  53. 53. Mapping the solutions to the user requirements
  54. 54. Performance considerations of the BI system
  55. 55. Robust & extensible framework </li></ul>Source: Naveen K Vodapalli, 2009 <br />
  56. 56. Mapping out processes – High level to detailed<br />13<br /><ul><li>We typically think of clinical trial organization as hierarchical
  57. 57. Processes usually align to a particular level of hierarchy
  58. 58. Processes can be high level and then drill down</li></li></ul><li>Identifying milestones and KPI<br />14<br /><ul><li>Milestones are predefined events within a process or processes
  59. 59. Milestonescorrespond to predefined key events or values within the various levels of the process maps
  60. 60. Examples of Milestones would be:
  61. 61. IND Submission (Molecule Level)
  62. 62. Protocol Approval (Study Level)
  63. 63. FSFV (Site Level)</li></li></ul><li>Process Maps<br />15<br />
  64. 64. Identifying milestones and KPIs with process maps<br />16<br /><ul><li>KPIs are key operational indicators which are measured using information from processes, data, documents
  65. 65. KPIs are calculated or non-calculated values based on one or many datapoints
  66. 66. KPIs can be drilled in to see underlying KPIs and data or rolled-up to see higher level KPIs (they are hierarchal)
  67. 67. Examples of KPIs would be:
  68. 68. Time between FSFV and DB Lock (study level)
  69. 69. Time between last query and DB lock (study level)
  70. 70. Time to query resolution (study, site level)</li></li></ul><li>Identifying milestones and KPIs with process maps<br />17<br />
  71. 71. Identify data sources and integration points<br />18<br /><ul><li>Data sources for KPIs and Milestones can come from:
  72. 72. Documents and document metadata
  73. 73. Procedures and procedural data (workflows)
  74. 74. Databases (EDC, CTMS, Safety etc.)
  75. 75. Project plans and manual metrics
  76. 76. When thinking about data for KPIs and Milestones, it is important to identify unique data sources
  77. 77. Establishment and use of standards is key to be able to integrate data sources and procedures</li></li></ul><li>Integrating Processes through BPM<br />19<br />
  78. 78. Building an operational knowledge model<br />20<br />Dashboards – <br />roll-up, drill-down, drill-in<br /><ul><li>By identifying key metrics, milestones and indicators at all levels we are able to develop multi-dimensional dashboards
  79. 79. These dashboards allow up to move up and down in our operational knowledge
  80. 80. By adding a third dimension we are able to drill in both in terms of data but also time
  81. 81. This model enables us to pin point key factors which have positive/negative impacts on our operations </li></li></ul><li>Aligning with the QMS<br />21<br /><ul><li>Implementing this approach often requires changes to components of the QMS
  82. 82. When re-engineering processes break them down into clear steps, tasks, responsibilities and deliverable elements
  83. 83. Adopt and use available standards to define your metrics, KPIs and processes. (UML, BPMN, CDISC, etc.)
  84. 84. Clearly identify all interconnections on process maps
  85. 85. Re-engineer manual processes into automated processes
  86. 86. Finally align these elements to your BPM and collaborative environment</li></li></ul><li>Identifying milestones and KPIs with process maps<br />22<br />
  87. 87. Study Level Process Break Down (Site Management)<br />23<br />
  88. 88. Site Level Process Breakdown (Site Initiation)<br />24<br />
  89. 89. Site Level Sub-Process Breakdown (IMP Management)<br />25<br />
  90. 90. IMP Authorization Process Dependencies<br />26<br />
  91. 91. Enterprise Architecture<br />27<br />Enterprise<br />
  92. 92. System Design Process<br />(MS SharePoint)<br />SOPs<br />28<br />
  93. 93. 29<br />
  94. 94. BI Example Using Out of the Box SharePoint Tools<br />30<br />Excel Services<br />KPI<br />Dashboard<br />Forms<br />Workflows<br />Lists / Libraries<br />Source: Microsoft<br />
  95. 95. IMP Shipment Authorization Workflow<br />31<br />
  96. 96. Clinical Operations Document Library<br />32<br />
  97. 97. New IMP Shipment Authorization Request InfoPath Form<br />33<br />From CTMS<br />From SharePoint <br />Library<br />
  98. 98. New IMP Shipment Authorization Request in Forms Library<br />34<br />
  99. 99. IMP Shipment Request Approved by Clinical Operations (Form)<br />35<br />
  100. 100. IMP Shipment Request Approved by Clinical Operations (Library)<br />36<br />
  101. 101. 37<br />
  102. 102. 38<br />
  103. 103. IMP Shipment Authorization Dashboards<br />39<br />
  104. 104. Clinical Study Management – Milestones and KPIs<br />40<br />Time to Initiation <br />Time to Site<br />Closure<br />CTA<br />CDA<br />SQV<br />SIV<br />FSFV<br />LSLV<br />DB Lock Date<br />SCV<br />IRB Approval<br />CTM shipped<br />ISF Sent<br />ISF Complete<br />IRB Submission<br />CTM Shipment Authorization<br />
  105. 105. Clinical Study Management – the “Big Picture”<br />41<br />
  106. 106. Clinical Study Management Scorecard – Study level<br />42<br />
  107. 107. Clinical Study Management Scorecard – Region level<br />43<br />
  108. 108. 44<br />
  109. 109. Recommended approach<br />45<br />Map out R&D process maps; remember top-down approach<br />Identify processes (SOPs) and interactions for each level and step<br />Identify people and organizations who intervene in each process and step<br />Identify data sources<br />Identify key metrics, milestones and KPIs<br />Identify technology elements<br />Define a scope for pilot project<br />Implement and improve<br />
  110. 110. BPM<br />GAMP 5 (Issue Management, CAPA, etc.)<br />ISO<br />ICH<br />CDISC<br />Object Management Group [BPMN, UML, etc.] (www.omg.com)<br />BI<br />Metrics Champion (www.metricschampion.org )<br />Some BPM/Standards and Resources<br />46<br />
  111. 111. www.montrium.com<br />tpathareddy@montrium.com<br />Tel. 514-223-9153 ext. 208<br />flandry@montrium.com<br />Tel. 514-223-9153 ext. 213<br />Contact Info<br />47<br />

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