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Visit our website: www.clinovo.com Contact us today to accelerate your clinical trial: [email protected] BENEFITS CLINOVO CDISC SERVICES Sunnyvale Office +1 800 987 6007 Clinovo CDISC SoluKons ABOUT CLINOVO San Diego Office +1 760 579 7352 Sponsors are receiving clinical informaKon of increased complexity, from mulKple sources and different formats. As a result, clinical data submission has become Kme‐consuming, costly and error‐prone. To tackle this challenge, CDISC® (Clinical Data Interchange Standards ConsorKum) has been establishing new data standards to speed up data‐review and improve clinical data exchange, storage and archival. CDISC SDTM was recommended by the FDA in 2006 for electronic submissions to accelerate the FDA review process. Clinovo offers consulKng services and a free development tool, CDISC Express, to improve and accelerate your CDISC implementaKon. CDISC Express is a free SAS® applicaKon that automaKcally converts clinical data into CDISC SDTM. CDISC Express was designed in‐house to facilitate and accelerate FDA review. It is an innovaKve tool that has proven to successfully speed up data submission while reducing implementaKon costs. Our technology edge combined to our experience in standards implementaKon allows us to develop tailored CDISC soluKons that answer your needs. FEATURES Clinovo is your leading edge Clinical Data SoluKons Provider. We provide local medical device, biotechnology and pharmaceuKcal companies with full service biometrics, such as Clinical Data Management, Electronic Data Capture, BiostaKsKcs, and CDISC mapping. By leveraging best‐of‐breed technology, we develop and customize turn key soluKons that accelerate the clinical trial process and speed up regulatory review. CDISC capability assessments CreaKon of CDISC ADaM data for staKsKcal analysis ImplementaKon of client custom SDTM specificaKons CDISC data aggregaKon for ISS and ISR reporKng CDISC conversion from any clinical database ImplementaKon of CDASH compliant CRFs CDISC submission review CDISC training CDISC® is a registered trademark of CDISC, Inc. ® indicates USA registration. Other brand and product names are trademarks of their respective companies. Excel based mapping definiKons Global SDTM definiKons Extensible funcKon library Lab standard units and toxicity levels Generic SDTM validaKon tool Define.XML Download the applicaKon free of charge 4x Speed‐up of CDISC conversion Seamless maintenance of CDISC mapping Portability of Excel User friendly web interface Reusable macros Download CDISC Express now! Visit www.clinovo.com/cdisc

CDISC Express

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Page 1: CDISC Express

Visitourwebsite:www.clinovo.com

Contactustodaytoaccelerateyourclinicaltrial:[email protected]

BENEFITS

CLINOVOCDISCSERVICES

SunnyvaleOffice+18009876007

ClinovoCDISCSoluKons

ABOUTCLINOVO

SanDiegoOffice+17605797352

Sponsors are receiving clinical informaKon of increased complexity, frommulKplesourcesanddifferentformats.Asaresult,clinicaldatasubmissionhasbecomeKme‐consuming,costlyanderror‐prone.

To tackle this challenge, CDISC® (Clinical Data Interchange StandardsConsorKum)hasbeenestablishingnewdatastandardstospeedupdata‐reviewand improve clinical data exchange, storage and archival. CDISC SDTMwasrecommendedbytheFDAin2006forelectronicsubmissionstoacceleratetheFDAreviewprocess.

ClinovooffersconsulKngservicesandafreedevelopmenttool,CDISCExpress,toimproveandaccelerateyourCDISCimplementaKon.

CDISC Express is a free SAS® applicaKon that automaKcally converts clinicaldataintoCDISCSDTM.

CDISCExpresswasdesignedin‐housetofacilitateandaccelerateFDAreview.It is an innovaKve tool that has proven to successfully speed up datasubmissionwhilereducingimplementaKoncosts.

Our technology edge combined to our experience in standardsimplementaKon allows us to develop tailored CDISC soluKons that answeryourneeds.

FEATURES

Clinovo is your leading edge Clinical Data SoluKons Provider. We provide local medical device, biotechnology andpharmaceuKcalcompanieswithfullservicebiometrics,suchasClinicalDataManagement,ElectronicDataCapture,BiostaKsKcs,andCDISCmapping.By leveragingbest‐of‐breed technology,wedevelopand customize turnkey soluKons that accelerate theclinicaltrialprocessandspeedupregulatoryreview.

 CDISCcapabilityassessments

 CreaKonofCDISCADaMdataforstaKsKcalanalysis

 ImplementaKonofclientcustomSDTMspecificaKons

 CDISCdataaggregaKonforISSandISRreporKng

 CDISCconversionfromanyclinicaldatabase

 ImplementaKonofCDASHcompliantCRFs

 CDISCsubmissionreview

 CDISCtraining

CDISC® is a registered trademark of CDISC, Inc. ® indicates USA registration. Other brand and product names are trademarks of their respective companies.

 ExcelbasedmappingdefiniKons GlobalSDTMdefiniKons ExtensiblefuncKonlibrary Labstandardunitsandtoxicitylevels GenericSDTMvalidaKontool Define.XML

 DownloadtheapplicaKonfreeofcharge 4xSpeed‐upofCDISCconversion SeamlessmaintenanceofCDISCmapping PortabilityofExcel Userfriendlywebinterface Reusablemacros

Download CDISC Express now! Visit www.clinovo.com/cdisc