The Benefits of Siebel Clinical Integration
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The Benefits of Siebel Clinical Integration

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The Benefits of Siebel Clinical Integration The Benefits of Siebel Clinical Integration Presentation Transcript

  • The Benefits of SiebelClinical IntegrationParam Singhwith Tricia O’Donnell of Covidien
  • Introductions• Param SinghVice President of Clinical TrialManagement SolutionsBioPharm Systems, Inc.• Tricia O’DonnellDirector of Central Admin GroupCovidien
  • Today’s AgendaTime Topic1:00-1:05 Welcome and Introductions1:05-1:15 CTMS Integrations- Commonly integrated systems- Kinds of data shared- Ideal situation for each integration1:15-1:20 Strategies and Methods- Data Replication vs. Data Sharing- Real-Time vs. Batch1:20-1:30 Covidien Case Study1:30-1:50 Covidien Integration Demo1:50-2:00 Wrap Up / Q&A
  • CTMS IntegrationsClinical Data Management (CDM)Electronic Data Capture (EDC)• Example: Oracle Clinical / RDC• Kinds of data shared– Subject– Subject visit• Ideal Situation– Both systems and processes are stableand clearly defined
  • CTMS IntegrationsInteractive Voice Response (IVR)• Example: United BioSourceCorporation (UBC)• Kinds of data shared– Subject– Subject visit• Ideal Situation– XML based IVR system to ensure nopoint-to-point
  • CTMS IntegrationsFinancial• Example: SAP Enterprise ResourcePlanning (ERP) Financials• Kinds of data shared– Payment requests– Details about processed payments• Ideal Situation– Entire organization uses singlefinancial system and process
  • CTMS IntegrationsSafety• Example: Argus• Kinds of data shared– Serious adverse event• Ideal Situation– Both systems and processes arestable and clearly defined
  • CTMS IntegrationsElectronic Document Management(EDM)• Example: Documentum• Kinds of data shared– Electronic document• Ideal Situation– Web-based system– Clinical hierarchy in both systems issimilar
  • CTMS IntegrationsClinical Data Warehouse• Example: Oracle Business IntelligenceEnterprise Edition (OBIEE)• Kinds of data shared– Key metrics– Performance indicators• Ideal Situation– Ample data in source system– Key performance indicators identified
  • CTMS IntegrationsCRO System• Example: Clinical Trial ManagementSystem (CTMS)• Kinds of data shared– Site– Subject– Subject visit• Ideal Situation– Incremental loads– No point-to-point
  • Today’s AgendaTime Topic1:00-1:05 Welcome and Introductions1:05-1:15 CTMS Integrations- Commonly integrated systems- Kinds of data shared- Ideal situation for each integration1:15-1:20 Strategies and Methods- Data Replication vs. Data Sharing- Real-Time vs. Batch1:20-1:30 Covidien Case Study1:30-1:50 Covidien Integration Demo1:50-2:00 Wrap Up / Q&A
  • Integration Strategies• Data ReplicationCopy data between applicationsto keep data synchronized in both• Data SharingAccess data in another applicationwithout replicating any data
  • Integration Methods• Real-TimeChanges made to data in sourcesystem are immediately reflectedin target system• BatchScheduled at specific intervals ortriggered by specific actions
  • Today’s AgendaTime Topic1:00-1:05 Welcome and Introductions1:05-1:15 CTMS Integrations- Commonly integrated systems- Kinds of data shared- Ideal situation for each integration1:15-1:20 Strategies and Methods- Data Replication vs. Data Sharing- Real-Time vs. Batch1:20-1:30 Covidien Case Study1:30-1:50 Covidien Integration Demo1:50-2:00 Wrap Up / Q&A
  • Covidien Case StudyBusiness Situation• Two global systems (Siebel ClinicalCTMS and Oracle Clinical CDMS)• Duplicate data entry• Human error• Extra time and resources needed toenter, review, and clean data• Delayed investigator payment process• Lack of visibility into comprehensiveclinical trial data
  • Covidien Case StudyDesired Outcomes• Save time• Save money• Reallocate resources to other tasks• Improve relationships with investigators• Improve methods for planning andmanaging clinical trialsSolution:Integrate OC/RDC and SC
  • OC/SC TerminologyOracle Clinical Siebel ClinicalSite AccountInvestigator ContactClinical Study ProtocolStudy Site SiteClinical PlannedEventsSVT – VisitsDCIs & Questions SVT – Visit ActivitiesPatient SubjectClinical PlannedEvent/ Actual EventSubject VisitCRFs(DCIs/Questions)Subject VisitActivities
  • Integration ScopeOracleClinicalSiebelClinicalSubjectsSubject VisitsSubject Visit ActivitiesPatientsActual EventsDCI/DCM/Questions
  • Overall Process Flow1. Set up study in OC2. Set up study in SC3. Select study to be integrated4. Complete mapping between SC(SVT)&OC5. Activate study in SC to bring inintegration data6. Interface auto-creates Subject, SubjectVisit, Subject Visit Activity, CRF, SAE*,and Protocol Deviation* records7. Review and adjust integration data asneeded based on the error/change logs innew Integration Admin view
  • Process Flow Detail4. Complete mapping between SC & OCSubject visittemplates - VisitsSubject visittemplates – VisitActivitiesClinical PlannedEventsDCIs Questions1:M Mapping 1:M Mapping1:1 MappingSiebel ClinicalOracle Clinical
  • Today’s AgendaTime Topic1:00-1:05 Welcome and Introductions1:05-1:15 CTMS Integrations- Commonly integrated systems- Kinds of data shared- Ideal situation for each integration1:15-1:20 Strategies and Methods- Data Replication vs. Data Sharing- Real-Time vs. Batch1:20-1:30 Covidien Case Study1:30-1:50 Covidien Integration Demo1:50-2:00 Wrap Up / Q&A
  • Demo
  • Benefits of CovidienIntegration Approach• Reduced manual entry of ClinicalData in multiple systems• Enhanced data consistency acrossCTMS and OC/RDC by minimizingmanual errors• Reduced the overall timeline forStudy Management• Ability to integrate selectivestudies
  • Wrap Up / Q&A