Normalized Automated Tracking System
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Transcript of Normalized Automated Tracking System
Clinical trials are required to collect and analyze data regarding the safety and efficacy of new drugs anddevices.Accurateresultsareen:relydeterminedbythequalityofthedatacollected.
Withouttherighttools,datacleaningandquerymanagementcanprove:me‐consumingandoverwhelming,resul:ng in trial delays, which in turn leads to considerable loss of revenue. As an example, in 2009,Genentech’s Hercep:n generated $1.2 billion revenues before the end of the patent expira:on, i.e. $106millionpermonth.
Byusingour latesttoolN.E.A.T. (NormalizedEditchecksAutomatedTracking),sponsorscanshorten:meforFDAsubmissionbyefficientlycleaningcollecteddataaswellaseasilyissuingandtrackingqueries.
EDChasmaderapidprogressoverpaper‐basedtrials,significantlyreducingqueryresolu:oncosts.Asaresult,manyEditChecksareprogrammed in an EDC system to ensure high data qualitythroughfastqueryresolu:on.However,itisnotalwaysfeasibletoprogramallEditChecksinEDCbeforethestartofthetrial.
SomeEditChecksaretoocomplexorcostlytoprogramwithinanEDCsystem.
Datamanagersorbio‐sta:s:cians realize theneed for specificEditChecksonlyoncethedatahasbeenreviewedandanalyzed.Atthispoint,thevalida:onforanewreleaseofEDCwithnewEditCheckswouldbecostprohibi:ve.
DataManagem
ent
Furthermore,combiningEDCandSASEditCheckswithoutintegra:oncanquicklybecomeatrackingnightmareandoWenleadstohumanerror.
NEATisaddressingthispain‐pointcommontoallEDCruntrials.
NEATisanapplica:onthatstreamlinesqueryprocessingforanyEDCsystem.ItcentralizesqueryprocessingfromEDC
andexternalsystemswhileensuringfullclinicaldataintegrity.
N.E.A.T.providescri:calmetricsrelatedtoqueryresolu:onandsiteperformance.
DatamanagersuseN.E.A.T.communica:onfacilitytofollow‐upwithsitesaboutoutstandingqueriesefficiently.
N.E.A.T.isacuYng‐edgeSAS®‐basedsolu:onfordatacleaningautoma:onthatenhancesautomatededitchecks.
As an integrated tool,N.E.A.T. combinesboth EDCandquerymanagement inoneunique system. It providesData
Managerswithfaster,moreaccuratedatacleaningandensuresdataconsistency.
NORMALIZEDEDITCHECKSAUTOMATEDTRACKING(N.E.A.T.) N.E.A.T.leveragesthepowerfulcapabili:esofSAS®,theindisputableleaderinbusinessintelligence. Theapplica:oniscompa:blewithanyEDCsystem.
Awebversionisavailable,easiertomanageandconfigurethanexcelspreadsheets.
Ourexpertsareabletofullycustomizeandimplementthesystemtoanyspecificstudyinaround4weeks.
BENEFITS Bringtogetherqueriesfrommul:plesources
Highstandardofdataqualityandintegrity Fasterandsimplerquerymanagementprocess
Queriesresolu:on Automatedsiteperformancemetrics
Crossplacorm,supportallEDCsystems
N.E.A.T.wasselectedforpresenta:onatWUSSannualconference amongst an « overwhelming number ofsubmissions».
Learnmorebyreadingourpressreleaseat
www.clinovo.com/wuss
OURTRACKRECORD
PRODUCTFEATURES
N.E.A.T.Core Configura)on: Data Managers and
Edit Checks
Ac)on List: Suggested queries to be processed by the data manager
QC New Edit Checks: New Edit Checks tes)ng mechanism
Unresolved Closed Queries Queries Master View: All SAS® & EDC
queries with audit trail
N.E.A.T.Dashboard N.E.A.T.SiteManagement
ABOUTUS
We are the leading technology Clinical Data Solu:on Provider delivering the fastest clinical trial developmentimplementa:onintheindustry.
Leveragingasuiteofinternalclinicalapplica:onsaswellasbest‐of‐breednewtechnologies,weofferexpert,tailor‐madebiometricsservicestoaccelerateclinicaltrialsandensuresuccessfulFDAsubmission.
OurcomprehensivesuiteofservicesincludesEDC,datamanagement,biosta:s:cs,andCDISC.WeareexpertsinopensourceclinicaltrialtechnologiessuchasOpenClinica,allowingustodeliversomeoftheindustry’smostcost‐effec:vesolu:ons.
Contact us today to accelerate your clinical trial! 800‐987‐6007
N.E.A.T.hasbeen inproduc:on for4yearsandhassuccessfullybeenused for4different studies involvingover20,000pa:ents.
Queryresolu:onrateincreased6‐fold From8to50queriesresolved/day
3,000queriesresolvedin2monthsforFDAreport
Over15,000discrepanciesresolvedfor1study Cleanupofover2,000pa:entsforFDAannualreport
N.E.A.T.
DataManagementSolu:ons