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PharmacovigilancemanagedbyCARA
Abouttheissue
AllinCARAorintegratewith3rd
Parties
WeprovidefullPVcasemanagementin
CARA,orprovidethecontentmanagement
partofitthroughintegrationswithARGUSor
ARISGlobalformanagingpatientsafetydata.
Securecontentstorage
Leveragethescalabilityandsecurityof
CARAforstoringSeriousAdverseEvent
(SAE)datainthecloudoronpremise.
CostSavings
Fromreducedlicensing,consolidated
(regional)caseprocessing,reducedresource
needs,anddeduplicationofrecords.
CentralizedandCompliantStorage
Maintaindocumentsreceivedfromglobal
sitesinacentralrepositoryina21CFRpart
11compliantrepository.
TBofdatacausesperformanceissuesinmaintainingdocumentsinARGUS/ARISg
DataredundancymultiplecopiesofsamedocumentkeptinARGUS/ARISgdatabasesduetothe
needofthesamedocumentthatneedstobetiedtomultiplecases
CostsUseraccessforlicensesarehigherinARGUS/ARISg
NodocumentationarchivingsolutionsforARGUS/ARISg
Nocentralrepositoryformaintainingdocumentsinavalidatedsystem
LittleintegrationwithdocumentswhicharethenusedinsubmissionsLittleintegrationwithdocumentswhicharethenusedinsubmissions
IntegrationwithARGUS/ARISghasanalternativetouseCARAPVmodulewithCARAdocuments
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,andE鍖ortDuplication
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
IntakeWorklistIncludesmetadataaroundpatient
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
fasterprocessingtimesandincreasedine鍖ciency
CostsavingsfromreducedARGUS/ARISglicensesCostsavingsfromreducedARGUS/ARISglicenses
IntegrationaccountisusedtomaintainCARAdocu-
mentsecurityprivileges
SinglePoint
ofTruth
WeprovideaVAP(ValidationAcceleratorPack)forCARA
Enablescustomerstomeetindustryregulationssuchas21CFRPart11
SinglePointofTruthismaintainedinCARAforregulatorypurposes
Weprovidesadditionalprojectmanagement/implementationservices
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CARA for Pharmacovigilance