This document discusses improving clinical trial management through breaking down organizational and data silos. It recommends taking a holistic business process management approach to map processes, identify metrics and KPIs, integrate data sources and re-engineer workflows. An example is provided of using SharePoint to automate an IMP shipment authorization process through integrated forms, workflows and dashboards. This helps provide end-to-end visibility of operations and accelerate decision making.

1. 1 Beyond Automation: Extracting Actionable Intelligence from Clinical Trials Tevin Pathareddy Fred Landry

2. Introduction 2

4. Holistic approach to CT management

5. Aligning your organization through BPM

6. Feeding your business brain with BI

7. Putting SharePoint to value added use

8. A real life SP example: IMP Shipment Authorization

9. Rolling knowledge into dashboards3

11. Resources (Individuals, groups and organizations)

12. Computerized systems

13. Departments or organization specific processes

14. All generate data and information which for the most part remains dislocated and underexploited

16. NVA transcribing, reconciling and collating data

17. Unclear study progress at any one point in time becoming even murkier across programs of studies

18. Under exploitation of operational data

19. Opposing sets of metrics and KPIs across functions

21. Make better drug development decisions

22. Accelerate time to market

23. Increase organizational efficiency and agility

24. Improve understanding and management of R&D processes

25. Reduce cost

26. Reduce risk

27. Improve quality

29. Leveraging new technologies and work methods

30. Map out, re-engineer, automate and integrate processes

31. Leverage and establish procedural and data standards

32. Integrate computerized systems and data sources

33. Identify clear and measurable metrics and KPIs

35. It is a holistic management approach that promotes business effectiveness and efficiency while striving for innovation, flexibility, and integration with technology

36. Is based on continuous improvement of processesSource: Wikipedia

38. Excel services

39. Performance Point

40. Workflows

41. Sites and Sub-Sites

42. Task lists

43. Calendars

44. Blogs

47. BI technologies provide historical, current, and predictive views of business operations

48. BI is composed on reports, dashboards, metrics and analytical models

50. Clear vision & planning

51. Committed management support & sponsorship

52. Data management & quality issues

53. Mapping the solutions to the user requirements

54. Performance considerations of the BI system

55. Robust & extensible framework Source: Naveen K Vodapalli, 2009

57. Processes usually align to a particular level of hierarchy

59. Milestonescorrespond to predefined key events or values within the various levels of the process maps

60. Examples of Milestones would be:

61. IND Submission (Molecule Level)

62. Protocol Approval (Study Level)

65. KPIs are calculated or non-calculated values based on one or many datapoints

66. KPIs can be drilled in to see underlying KPIs and data or rolled-up to see higher level KPIs (they are hierarchal)

67. Examples of KPIs would be:

68. Time between FSFV and DB Lock (study level)

69. Time between last query and DB lock (study level)

72. Documents and document metadata

73. Procedures and procedural data (workflows)

74. Databases (EDC, CTMS, Safety etc.)

75. Project plans and manual metrics

76. When thinking about data for KPIs and Milestones, it is important to identify unique data sources

79. These dashboards allow up to move up and down in our operational knowledge

80. By adding a third dimension we are able to drill in both in terms of data but also time

82. When re-engineering processes break them down into clear steps, tasks, responsibilities and deliverable elements

83. Adopt and use available standards to define your metrics, KPIs and processes. (UML, BPMN, CDISC, etc.)

84. Clearly identify all interconnections on process maps

85. Re-engineer manual processes into automated processes

87. Study Level Process Break Down (Site Management) 23

88. Site Level Process Breakdown (Site Initiation) 24

89. Site Level Sub-Process Breakdown (IMP Management) 25

90. IMP Authorization Process Dependencies 26

91. Enterprise Architecture 27 Enterprise

92. System Design Process (MS SharePoint) SOPs 28

93. 29

94. BI Example Using Out of the Box SharePoint Tools 30 Excel Services KPI Dashboard Forms Workflows Lists / Libraries Source: Microsoft

95. IMP Shipment Authorization Workflow 31

96. Clinical Operations Document Library 32

97. New IMP Shipment Authorization Request InfoPath Form 33 From CTMS From SharePoint Library

98. New IMP Shipment Authorization Request in Forms Library 34

99. IMP Shipment Request Approved by Clinical Operations (Form) 35

100. IMP Shipment Request Approved by Clinical Operations (Library) 36

101. 37

102. 38

103. IMP Shipment Authorization Dashboards 39

104. Clinical Study Management – Milestones and KPIs 40 Time to Initiation Time to Site Closure CTA CDA SQV SIV FSFV LSLV DB Lock Date SCV IRB Approval CTM shipped ISF Sent ISF Complete IRB Submission CTM Shipment Authorization

105. Clinical Study Management – the “Big Picture” 41

106. Clinical Study Management Scorecard – Study level 42

107. Clinical Study Management Scorecard – Region level 43

108. 44

109. Recommended approach 45 Map out R&D process maps; remember top-down approach Identify processes (SOPs) and interactions for each level and step Identify people and organizations who intervene in each process and step Identify data sources Identify key metrics, milestones and KPIs Identify technology elements Define a scope for pilot project Implement and improve

110. BPM GAMP 5 (Issue Management, CAPA, etc.) ISO ICH CDISC Object Management Group [BPMN, UML, etc.] (www.omg.com) BI Metrics Champion (www.metricschampion.org ) Some BPM/Standards and Resources 46

111. www.montrium.com tpathareddy@montrium.com Tel. 514-223-9153 ext. 208 flandry@montrium.com Tel. 514-223-9153 ext. 213 Contact Info 47