SUSAR – Suspected Unexpected Serious Adverse Events ...

SUSAR expedited reporting is one of the core PrimeVigilance services. We provide the facility to delegate the onerous task of registration and set up of the ...     CLOSEMENU     CLOSE   PharmacovigilanceOperations–Clinicaltrials SUSAR–SuspectedUnexpectedSeriousAdverseEventsReporting Caseprocessing(SAEs) Clinicaltrialsafety SUSAR-SuspectedUnexpectedSeriousAdverseEventsReporting Periodicreporting(DSURs) ElectronicReportingofSuspectedUnexpectedSeriousAdverseEvents(SUSARS)isnowmandatoryinmanyglobalterritories. SUSARexpeditedreportingisoneofthecorePrimeVigilanceservices.Weprovidethefacilitytodelegatetheoneroustaskofregistrationandsetupoftheelectronicreportingroutesforthepharmacovigilancesystem.ExperiencedandEMA-trainedpersonnelensurethatexpeditedreportingmeetstheregulatoryrequirementsineachtrialterritory.WhetherelectronicorhardcopyPrimeVigilanceoffersconsolidatedexpeditedreportingservices. WHATISEXPEDITEDREPORTING? ASUSARthatmeetstheseriousnesscriteriaoflife-threateningand/orresultsindeathmustbereportedwithinseven(7)calendardays.ASUSARthatisnotlife-threateningordoesnotresultindeathmustbesubmittedtotheregulatoryauthoritieswithinfifteen(15)calendardays.Inadditiontotheregulatoryauthorities,aSUSARmayalsoneedtobereportedtootherrecipientsincludingethicscommitteeandinvestigators. AsaSponsor,youneedtobefullyversedineachchangetothedrugsafetylawsaroundSUSARreportingasandwhenithappens.Includingthechanges,youneedtointroducetoremainfullycompliant.WiththerightsupportyoucanrapidlyrespondtothechallengesinlinewithyourStandardOperatingProcedures. PRE-MARKETINGCLINICALTRIALPHASES PrimeVigilancehasconsiderableexperienceadvisingonthesubmissionofICSRsforclinicaltrialphases1-3.ThefocuswillinevitablyvaryfromtrialtotrialbutitshouldbenotedthatanySUSARissubjecttoextremelystrictdeadlinesforsubmission.PrimeVigilancecanadviseonwhen,whoandhowtosubmitandwhentoinsertinformationwithinaDevelopmentRiskManagementPlan,theDevelopmentSafetyUpdateReportsandEndofStudyReports. POST-MARKETINGPHASES Adversereactionsreportedduringclinicaltrialsinthepostmarketingphasee.g.PostAuthorisationSafetyStudies(PASS)andallspontaneousreportswillalsoneedtobecorrectlyexpedited. PrimeVigilanceplacesparticularemphasisonthetimelyreportingofSUSARs.WithachoiceoffullyvalidatedE2Bcompliantsafetydatabasesolutions(ArisGlobalLifeSphereSafetyMultiVigilanceTM andArgusOraclehealthSciencesSafety)highlyeffectiveSOPsandoperatingguidelines,thoroughemployeetrainingandaconstantqualitymanagementsystem‘ontime’reportingisamajorpriority.Reportsmaybemadeelectronicallyorbyhardcopyasrequiredbylocalregulations.PrimeVigilancecanregisterandrunelectronicreportingsystemssuchasEudraVigilance.OurEMA-trainedemployeesensurecompliancewiththerigorousrequirementsofsuchasystem. PrimeVigilance–CompliantandTimely JustoneofthepharmacovigilanceservicesfromPrimeVigilance FormoreinformationcontactPrimeVigilancetoday Caseprocessing(SAEs) Clinicaltrialsafety SUSAR-SuspectedUnexpectedSeriousAdverseEventsReporting Periodicreporting(DSURs) ReachouttousforatailoredProposalCONTACTUS SubmitRFI/RFP +44(0)1483307920 +17923740 Downloadourbrochure+44(0)1483307920   +1(919)7923740 LOCATIONS UnitedKingdom(HeadOffice)PrimeVigilanceLtd 1OccamCourt SurreyResearchPark Guildford,Surrey GU27HJUSAPrimeVigilanceUSAInc. 5430WadeParkBlvd. Suite#208 Raleigh NC27607USA   CroatiaPrimeVigilanceZagrebd.o.o. Oreskoviceva20A 10020Zagreb GermanyPrimeVigilanceGmbH Herriotstr.1, 60528, FrankfurtamMainCzechRepublicPrimeVigilances.r.o. Stetkova18 14000Praha4 SerbiaPrimeVigilanced.o.o.Beograd ĐorđaStanojevića14 11070NoviBeograd   PolandPrimeVigilance– ErgomedSp.z.o.o. Ul.ArmiiKrajowej18 30-150Krakow JapanPrimeVigilanceJapanK.K. 3-1-6Motoazabu,Minato-ku, Tokyo,Japan ©PrimeVigilance2022 An  groupcompany ©PrimeVigilance2022 Thissiteusescookiestopersonaliseandcustomiseyourexperience.Byclicking“IAccept",youconsenttocookiesinaccordancewithourprivacy policy. Iaccept CookieSettings PrivacySettingssaved! PrimeVigilance–Pharmacovigilance&MedicalInformation CookieSettings Whenyouvisitanywebsite,itmaystoreorretrieveinformationonyourbrowser,mostlyintheformofcookies.ControlyourpersonalCookieServiceshere. Necessary Preferences Analytics Marketing PrivacyPolicy Thesecookiesarenecessaryforthewebsitetofunctionandcannotbeswitchedoffinoursystems.TechnicalCookiesInordertousethiswebsiteweusethefollowingtechnicallyrequiredcookieswordpress_test_cookiewordpress_logged_in_wordpress_secCloudflare__cfduidPreferencecookiesenableawebsitetorememberinformationthatchangesthewaythewebsitebehavesorlooks,likeyourpreferredlanguageortheregionthatyouarein.ThirdVendorLoadBalancingwow.scheduleThesecookiesallowustocountvisitsandtrafficsources,sowecanmeasureandimprovetheperformanceofoursite.GoogleAnylyticsThirdVendorAnalyticswow.anonymousidwow.utmvaluesThirdVendorSessionwow.sessionThesecookiesaresetthroughoursitebyouradvertisingpartners.ThirdVendorMarketingwow.trackingdatawow.data DeclineallServices AcceptallServices