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CARA for Pharmacovigilance
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The CARA workspace brings together different aspects of PV in one place.
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CARA for Pharmacovigilance
1.
www.generiscorp.com PharmacovigilancemanagedbyCARA Abouttheissue AllinCARA–orintegratewith3rd Parties WeprovidefullPVcasemanagementin CARA,orprovidethecontentmanagement partofitthroughintegrationswithARGUSor ARISGlobalformanagingpatientsafetydata. Securecontentstorage Leveragethescalabilityandsecurityof CARAforstoringSeriousAdverseEvent (SAE)data–inthecloudoronpremise. CostSavings Fromreducedlicensing,consolidated (regional)caseprocessing,reducedresource needs,anddeduplicationofrecords. CentralizedandCompliantStorage Maintaindocumentsreceivedfromglobal sitesinacentralrepositoryina21CFRpart 11compliantrepository. TBofdatacausesperformanceissuesinmaintainingdocumentsinARGUS/ARISg Dataredundancy–multiplecopiesofsamedocumentkeptinARGUS/ARISgdatabasesduetothe needofthesamedocumentthatneedstobetiedtomultiplecases Costs–UseraccessforlicensesarehigherinARGUS/ARISg NodocumentationarchivingsolutionsforARGUS/ARISg Nocentralrepositoryformaintainingdocumentsinavalidatedsystem LittleintegrationwithdocumentswhicharethenusedinsubmissionsLittleintegrationwithdocumentswhicharethenusedinsubmissions IntegrationwithARGUS/ARISghasanalternativetouseCARAPVmodulewithCARAdocuments
2.
Contactusforademoorevaluationinfo@generiscorp.com|www.generiscorp.comContactusforademoorevaluationinfo@generiscorp.com|www.generiscorp.com CARAisdesignedtoserveasaseamlessplat- form forallregulatoryapplicationrequire- ments.However,werealisethatthereare otherapplicationsandmanytoolsthatyour businessrelieson. Theconceptofacentralsourceoftruthisto createasingleplacetoaccessallthatcontent anddataregardlessofwhereitisstoredand managed. WhileWhileaparticularbusinessgroupmayusea particulartoolfortheirnicheprocess,that contentanddataisavailableinCARAtobe tracked,managedandre-usedacrossyour business. Search&ReportAcrosstheEnterprise PreventContent,Information,andEffortDuplication ProvideaCentralAuthority EnterpriseCentralSourceofTruth Content-CARA PVinCARA/ARGUS/ARISg CARAisusedfordocumentinitiationandsending overtothePVsystem(CARAorARGUS/ARISg) Intakearea CARAreceivesdocumentsassociatedwithcasesfor archivalwithbettercompressionmethod. Processingofdocuments(suchasredacting)is doneinCARAusingproperpermissionsand versioncontrols.versioncontrols. MedicalRecords,workowchecks,andvalidations builtintotheprocess Completedcaseinformationisreceivedfromthe PV(CARAorARGUS/ARISg)anddocumentsare markedcompleted. AutomatedQCprocessformovinginputrecordstoAutomatedQCprocessformovinginputrecordsto QCcheckfolders IntakeWorklist–Includesmetadataaroundpatient casesalongwiththe
le Metadataforcasesincludedatapointssuchas Country,Data,Product,Event PatientcasesarecreatedinArgus/ARISg DocumentIntakeareacreatedtoreceiveinputles fromCARAso lesdonothavetobeentered directlyintoPV(CARAorARGUS/ARISg) Sending lesdirectlytoARGUS/ARISgwithout usingtheiruserinterfaceorCARAPVleveraged ARGUS/ARISgdirectintegrationfeaturesleveragedARGUS/ARISgdirectintegrationfeaturesleveraged orCARAPVused Documentsareaddedtoeitheranewcaseora followuptoanexistingcase SamedocumentfromCARAcontentstoreisused inmultiplePV(CARAorARGUS/ARISg)casesfor fasterprocessingtimesandincreasedinefficiency CostsavingsfromreducedARGUS/ARISglicensesCostsavingsfromreducedARGUS/ARISglicenses IntegrationaccountisusedtomaintainCARAdocu- mentsecurityprivileges SinglePoint ofTruth WeprovideaVAP(ValidationAcceleratorPack)forCARA Enablescustomerstomeetindustryregulationssuchas21CFRPart11 SinglePointofTruthismaintainedinCARAforregulatorypurposes Weprovidesadditionalprojectmanagement/implementationservices
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