Download - 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

[email protected]

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