Using the Metrics within SiebelClinical to Meet the Expectationsof End-User Reporting Needs                    November 5,...
Welcome & IntroductionsParam SinghVice President of Clinical Trial Management SolutionsBioPharm Systems, Inc.• CTMS practi...
Agenda•   Commonly Requested Siebel Clinical Metrics•   Out-of-the-Box Metrics•   Demo: Out-of-the-Box Metrics•   Addition...
Commonly Requested Siebel Clinical Metrics• Metrics to capture and track clinical information at multiple  levels (Protoco...
Categories of Out-of-the-Box Metrics• Site metrics• Subject metrics• Financial metricsNote: All metrics roll up to Site, R...
Out-of-the-Box Metrics: Site• Planned vs. actual sites• Key site milestone dates   – 1st site initiated   – Last site term...
Out-of-the-Box Metrics: Subject• Planned vs. actual subjects• Subject enrollment statistics• Key subject milestone dates  ...
Out-of-the-Box Metrics: Financial• Planned vs. actual   – Paid to date   – Earned to date                        8        ...
Demo: Out-of-the-Box Metrics                       9       PREVIOUS                               PREVIOUS   NEXT         ...
Additional Metrics Available via Data Manipulation• Query and export to Excel to calculate metrics   – i.e., site initiati...
Additional Metrics Available via Configuration• Payment custom metrics         • Site visit custom metrics   – Approval tu...
Additional Metrics Available via Configuration• Study dashboard / protocol summary   – High level view of progress of all ...
Additional Metrics Available via Configuration• Study dashboard / protocol summary (cont.)   – Study turnaround metrics   ...
Demo: Additional Metrics Available                       14            PREVIOUS                                     PREVIO...
Add-on Tools• Clinical Development Analytics (CDA)   – Dynamic customizable dashboard   – Prepackaged clinical metrics   –...
Add-on Tools• Clinical Data Analytics (CDA) (cont.)   – Study enrollment over time   – Site milestones reports      • Firs...
Audience Input• What types of study metrics does your organization track?  What types of metrics would you like to track b...
Summary• Out-of-the-box metrics                • Additional metrics   – Site                                    – Data Man...
Thank you for attending!Questions?                       19   PREVIOUS                            PREVIOUS   NEXT         ...
Contact Us• North America Sales Contact:   – Rod Roderick   – rroderick@biopharm.com   – +1 877 654 0033• Europe/Middle Ea...
Presenter – Param Singh• Contact   – psingh@biopharm.com   – +1 210 454 5192Param has been working in the life sciences in...
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Using the Metrics within Siebel Clinical to Meet the Expectations of End-User Reporting Needs

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Using the Metrics within Siebel Clinical to Meet the Expectations of End-User Reporting Needs

  1. 1. Using the Metrics within SiebelClinical to Meet the Expectationsof End-User Reporting Needs November 5, 2012 Parambir Singh Vice President of Clinical Trial Management Solutions BioPharm Systems 1 PREVIOUS PREVIOUS NEXT NEXT
  2. 2. Welcome & IntroductionsParam SinghVice President of Clinical Trial Management SolutionsBioPharm 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 2 PREVIOUS PREVIOUS NEXT NEXT
  3. 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 3 PREVIOUS PREVIOUS NEXT NEXT
  4. 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 4 PREVIOUS PREVIOUS NEXT NEXT
  5. 5. Categories of Out-of-the-Box Metrics• Site metrics• Subject metrics• Financial metricsNote: All metrics roll up to Site, Region, and Protocol levels 5 PREVIOUS PREVIOUS NEXT NEXT
  6. 6. Out-of-the-Box Metrics: Site• Planned vs. actual sites• Key site milestone dates – 1st site initiated – Last site terminated 6 PREVIOUS PREVIOUS NEXT NEXT
  7. 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 7 PREVIOUS PREVIOUS NEXT NEXT
  8. 8. Out-of-the-Box Metrics: Financial• Planned vs. actual – Paid to date – Earned to date 8 PREVIOUS PREVIOUS NEXT NEXT
  9. 9. Demo: Out-of-the-Box Metrics 9 PREVIOUS PREVIOUS NEXT NEXT
  10. 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 10 PREVIOUS PREVIOUS NEXT NEXT
  11. 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 11 PREVIOUS PREVIOUS NEXT NEXT
  12. 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 12 PREVIOUS PREVIOUS NEXT NEXT
  13. 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 13 PREVIOUS PREVIOUS NEXT NEXT
  14. 14. Demo: Additional Metrics Available 14 PREVIOUS PREVIOUS NEXT NEXT
  15. 15. Add-on Tools• Clinical Development Analytics (CDA) – Dynamic customizable dashboard – Prepackaged clinical metrics – Flexible ad hoc reporting capability 15 PREVIOUS PREVIOUS NEXT NEXT
  16. 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 16 PREVIOUS PREVIOUS NEXT NEXT
  17. 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 17 PREVIOUS PREVIOUS NEXT NEXT
  18. 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 18 PREVIOUS PREVIOUS NEXT NEXT
  19. 19. Thank you for attending!Questions? 19 PREVIOUS PREVIOUS NEXT NEXT
  20. 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 20 PREVIOUS PREVIOUS NEXT NEXT
  21. 21. Presenter – Param Singh• Contact – psingh@biopharm.com – +1 210 454 5192Param has been working in the life sciences industry hisentire career. As vice president of CTMS at BioPharm, hedeveloped the CTMS practice to become one of the best inthe industry.With a knack for resource and project management, Paramleads a highly skilled team of implementation specialists andcontinues to build lasting relationships with clients. 21 PREVIOUS PREVIOUS NEXT NEXT

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