2013 OHSUG - Best Practices for Setting up the CDA Repository for CTMS/OC
Using Siebel Clinical Metrics to Meet End-User Reporting Needs
1. Using the Metrics within Siebel
Clinical to Meet the Expectations
of End-User Reporting Needs
November 5, 2012
Parambir Singh
Vice President of
Clinical Trial Management Solutions
BioPharm Systems
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2. Welcome & Introductions
Param Singh
Vice President of Clinical Trial Management Solutions
BioPharm 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
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3. Agenda
• Commonly Requested Siebel Clinical Metrics
• Out-of-the-Box Metrics
• Demo: Out-of-the-Box Metrics
• Additional Metrics Available via Data Manipulation and
Configuration
• Demo: Additional Metrics Available
• Add-on Tools
• Audience Input
• Summary
• Q&A
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4. Commonly Requested Siebel Clinical Metrics
• Metrics to capture and track clinical information at multiple
levels (Protocol, Region, and Country level)
• Metrics to monitor the project status and benchmark it
against performance milestones, critical events, and
budgeted costs
• Subject status and enrollment rates plotted for sites,
regions, and protocols
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5. Categories of Out-of-the-Box Metrics
• Site metrics
• Subject metrics
• Financial metrics
Note: All metrics roll up to Site, Region, and Protocol levels
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6. Out-of-the-Box Metrics: Site
• Planned vs. actual sites
• Key site milestone dates
– 1st site initiated
– Last site terminated
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7. Out-of-the-Box Metrics: Subject
• Planned vs. actual subjects
• Subject enrollment statistics
• Key subject milestone dates
– 1st subject enrolled
– Last subject off study
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10. Additional Metrics Available via Data Manipulation
• Query and export to Excel to calculate metrics
– i.e., site initiation and enrollment progress for a study
1. Query site by protocol and site status
2. Export to Excel
3. Use Excel’s COUNT function to get # of sites initiated and # of
active sites (enrolling)
4. Compare site statistics to planned site progress
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11. Additional Metrics Available via Configuration
• Payment custom metrics • Site visit custom metrics
– Approval turnaround – Approval turnaround
– Total turnaround – Submission turnaround
– Total turnaround
– Weeks since last visit
• Site custom metrics
– Startup to IRB submission
– Startup to IRB approval
– Startup to SIV
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12. Additional Metrics Available via Configuration
• Study dashboard / protocol summary
– High level view of progress of all studies
• Protocol name, status, phase, etc.
– Planned vs. actual
• Subject forecasting: # screened, # enrolled, # completed, etc.
• Site progress: # initiated, # active, # completed, etc.
– Key study milestone tracking
• Signed protocol
• 1st SIV
• FSFV
• LSLV
• Database lock
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13. Additional Metrics Available via Configuration
• Study dashboard / protocol summary (cont.)
– Study turnaround metrics
• Approved protocol to FPI
• Enrollment time period
• LPO to final database lock
• Final database lock to final analysis
• Final analysis to CSR
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15. Add-on Tools
• Clinical Development Analytics (CDA)
– Dynamic customizable dashboard
– Prepackaged clinical metrics
– Flexible ad hoc reporting capability
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16. Add-on Tools
• Clinical Data Analytics (CDA) (cont.)
– Study enrollment over time
– Site milestones reports
• First and latest subjects screened, enrolled, and randomized
– Comparative graphs for site progress over time
• Cumulative screening vs. enrollment
• Cumulative enrollment vs. early termination
– Clinical document cycle times report
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17. Audience Input
• What types of study metrics does your organization track?
What types of metrics would you like to track but don’t
know how?
Program Protocol Region
Site Subject Subject Visits
Payments Documents Site Visit Reports
Contacts Accounts Protocol Deviations
Activities Follow-up Items Monitored AEs
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18. Summary
• Out-of-the-box metrics • Additional metrics
– Site – Data Manipulation
• Planned vs. actual sites • Query and export to Excel
• Key site milestone dates – Custom Payments
– Subject • Turnaround times
• Planned vs. actual subjects – Custom Sites
• Subject enrollment statistics • Initiation date to various
• Key subject milestone dates milestones
– Financial – Custom Site Visits
• Planned vs. actual • Turnaround times
• Time between visits
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19. Thank you for attending!
Questions?
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20. Contact Us
• North America Sales Contact:
– Rod Roderick
– rroderick@biopharm.com
– +1 877 654 0033
• Europe/Middle East/Africa Sales Contact:
– Rudolf Coetzee
– rcoetzee@biopharm.com
– +44 (0) 1865 910200
• General Inquiries:
– info@biopharm.com
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21. Presenter – Param Singh
• Contact
– psingh@biopharm.com
– +1 210 454 5192
Param has been working in the life sciences industry his
entire career. As vice president of CTMS at BioPharm, he
developed the CTMS practice to become one of the best in
the industry.
With a knack for resource and project management, Param
leads a highly skilled team of implementation specialists and
continues to build lasting relationships with clients.
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