1. Exploring Metrics in Siebel Clinical
November 29, 2012
Parambir Singh
Vice President of
Clinical Trial Management Solutions
BioPharm Systems

2. Welcome & Introductions
Param Singh
Vice President of Clinical Trial Management Solutions
BioPharm Systems, Inc.
• CTMS practice head since 2007
– Expertise in managing all phases and styles of clinical trials
– Leads the team that implements, supports, and enhances Oracle’s
Siebel Clinical and LabPas solutions
• Extensive Siebel Clinical implementation experience
– 11+ years of experience implementing Siebel Clinical
– 25+ implementations and integrations
– Spearheaded the creation of ASCEND, an official Oracle Accelerate
Solution for Siebel Clinical

3. Welcome & Introductions
CTMS Practice Services
Implementations
Manage implementations of Siebel
Clinical, Siebel Clinical ASCEND, and
Oracle Health Sciences LabPas.
Integrations
Build interfaces between Siebel Clinical
or LabPas and other clinical and non-
clinical systems.
Training
Develop and/or deliver standard and
custom training classes and materials.
Process Guidance
Provide insight, advice, and solutions
to specific clinical trial management
issues.

4. 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

5. 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

6. Categories of Out-of-the-Box Metrics
• Site metrics
• Subject metrics
• Financial metrics
Note: All metrics roll up to Site, Region, and Protocol levels

7. Out-of-the-Box Metrics: Site
• Planned vs. actual sites
• Key site milestone dates
– 1st site initiated
– Last site terminated

8. Out-of-the-Box Metrics: Subject
• Planned vs. actual subjects
• Subject enrollment statistics
• Key subject milestone dates
– 1st subject enrolled
– Last subject off study

9. Out-of-the-Box Metrics: Financial
• Planned vs. actual
– Paid to date
– Earned to date

10. Demo: Out-of-the-Box Metrics

11. 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

12. Additional Metrics Available via Configuration
• Payment custom metrics
– Approval turnaround
– Total turnaround
• Site custom metrics
– Startup to IRB submission
– Startup to IRB approval
– Startup to SIV
• Site visit custom metrics
– Approval turnaround
– Submission turnaround
– Total turnaround
– Weeks since last visit

13. 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

14. 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

15. Demo: Additional Metrics Available

16. Demo: Screenshots
1

17. Demo: Screenshots
1

18. Demo: Screenshots
1

19. Add-on Tools
• Clinical Development Analytics (CDA)
– Dynamic customizable dashboard
– Prepackaged clinical metrics
– Flexible ad hoc reporting capability

20. Add-on Tools
• Clinical Development 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

21. 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

22. Summary
• Out-of-the-box metrics
– Site
• Planned vs. actual sites
• Key site milestone dates
– Subject
• Planned vs. actual subjects
• Subject enrollment statistics
• Key subject milestone dates
– Financial
• Planned vs. actual
• Additional metrics
– Data Manipulation
• Query and export to Excel
– Custom Payments
• Turnaround times
– Custom Sites
• Initiation date to various
milestones
– Custom Site Visits
• Turnaround times
• Time between visits

23. Q&A

24. Contact Us / Thank you for attending!
• 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