Exploring Metrics in Siebel Clinical

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Exploring Metrics in Siebel Clinical

  1. 1. Exploring Metrics in Siebel ClinicalNovember 29, 2012Parambir SinghVice President ofClinical Trial Management SolutionsBioPharm Systems
  2. 2. Welcome & IntroductionsParam SinghVice President of Clinical Trial Management SolutionsBioPharm 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’sSiebel 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 AccelerateSolution for Siebel Clinical
  3. 3. Welcome & IntroductionsCTMS Practice ServicesImplementationsManage implementations of SiebelClinical, Siebel Clinical ASCEND, andOracle Health Sciences LabPas.IntegrationsBuild interfaces between Siebel Clinicalor LabPas and other clinical and non-clinical systems.TrainingDevelop and/or deliver standard andcustom training classes and materials.Process GuidanceProvide insight, advice, and solutionsto specific clinical trial managementissues.
  4. 4. Agenda• Commonly Requested Siebel Clinical Metrics• Out-of-the-Box Metrics• Demo: Out-of-the-Box Metrics• Additional Metrics Available via Data Manipulation andConfiguration• Demo: Additional Metrics Available• Add-on Tools• Audience Input• Summary• Q&A
  5. 5. Commonly Requested Siebel Clinical Metrics• Metrics to capture and track clinical information at multiplelevels (Protocol, Region, and Country level)• Metrics to monitor the project status and benchmark itagainst performance milestones, critical events, andbudgeted costs• Subject status and enrollment rates plotted for sites,regions, and protocols
  6. 6. Categories of Out-of-the-Box Metrics• Site metrics• Subject metrics• Financial metricsNote: All metrics roll up to Site, Region, and Protocol levels
  7. 7. Out-of-the-Box Metrics: Site• Planned vs. actual sites• Key site milestone dates– 1st site initiated– Last site terminated
  8. 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. 9. Out-of-the-Box Metrics: Financial• Planned vs. actual– Paid to date– Earned to date
  10. 10. Demo: Out-of-the-Box Metrics
  11. 11. Additional Metrics Available via Data Manipulation• Query and export to Excel to calculate metrics– i.e., site initiation and enrollment progress for a study1. Query site by protocol and site status2. Export to Excel3. Use Excel’s COUNT function to get # of sites initiated and # ofactive sites (enrolling)4. Compare site statistics to planned site progress
  12. 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. 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. 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. 15. Demo: Additional Metrics Available
  16. 16. Demo: Screenshots1
  17. 17. Demo: Screenshots1
  18. 18. Demo: Screenshots1
  19. 19. Add-on Tools• Clinical Development Analytics (CDA)– Dynamic customizable dashboard– Prepackaged clinical metrics– Flexible ad hoc reporting capability
  20. 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. 21. Audience Input• What types of study metrics does your organization track?What types of metrics would you like to track but don’tknow how?Program Protocol RegionSite Subject Subject VisitsPayments Documents Site Visit ReportsContacts Accounts Protocol DeviationsActivities Follow-up Items Monitored AEs
  22. 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 variousmilestones– Custom Site Visits• Turnaround times• Time between visits
  23. 23. Q&A
  24. 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

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