GenerisCorp provides pharmacovigilance case management and content storage solutions using their CARA platform. CARA allows for full PV case management or integration with third party systems like ARGUS or ARIS Global. It provides secure storage of safety data in the cloud or on-premise. Use of CARA can reduce costs through licensing savings, consolidated case processing, and deduplication of records. CARA also maintains documents from global sites in a centralized and 21 CFR Part 11 compliant repository.

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

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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