medidata rave services

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Visit our website: www.clinovo.com Contact us today to accelerate your clinical trial: [email protected] OUR EDC EXPERTISE Sunnyvale Office, CA +1 408 773 6254 Clinovo EDC SoluOons San Diego Office, CA +1 760 579 7352 MEDIDATA RAVE SERVICES ABOUT CLINOVO When so much is at stake, you can only rely on a proven soluOon. Clinovo supports the EDC industry leader: Medidata Rave. Clinovo is able to tailor the Rave EDC plaZorm through custom funcOons to meet your specific protocol requirements and achieve faster study build. Medidata Rave cerOfied study builders Agile implementaOon Back end integraOon Study migraOon Industry standard based architecture User acceptance tesOng Global library set‐up Custom funcOons development ConfiguraOon of user‐interface and workflow eCRF design and customizaOon User‐controlled access to eCRFs/data entry Complex edit checks configuraOon and verificaOon AN EXPERIENCED TEAM FULL CUSTOMIZATION Best of breed technology and industry experOse Local dedicated team of experts Expert in FDA standards and guidelines 21 CFR Part 11 validaOon Excellent data accuracy and integrity Customized plaZorm design Regulatory requirements have significantly lengthened and complicated clinical trials, resulOng in an 11% annual rise in clinical tesOng expenses and delays in FDA submission. As a result, sponsors are looking for efficient technology soluOons, such as EDC, to avoid human error during data collecOon and assess clinical data quality at an earlier stage. ImplemenOng a new EDC system requires in‐house technology experOse that can prove Ome consuming and expensive to acquire. Your local Clinovo team will guide you through the enOre set‐up and implementaOon process to help you significantly reduce your Ome to market. Clinovo is your leading edge Clinical Data SoluOons Provider. We provide local medical device, biotechnology and pharmaceuOcal companies with full service biometrics, such as Clinical Data Management, Electronic Data Capture, BiostaOsOcs, and CDISC mapping. By leveraging best‐of‐breed technology, we develop and customize turn key soluOons that accelerate the clinical trial process and speed up regulatory review.

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Clinovo supports Medidata Rave, the current industry leading Electronic Data Capture and Clinical Data Management System. Clinovo is able to tailor the Rave EDC platform through custom functions to meet your specific protocol requirements and achieve faster study build.

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Page 1: Medidata Rave Services

Visitourwebsite:www.clinovo.com

Contactustodaytoaccelerateyourclinicaltrial:[email protected]

OUREDCEXPERTISE

SunnyvaleOffice,CA+14087736254

ClinovoEDCSoluOons

SanDiegoOffice,CA+17605797352

MEDIDATARAVESERVICES

ABOUTCLINOVO

Whensomuchisatstake,youcanonlyrelyonaprovensoluOon.ClinovosupportstheEDC industry leader:Medidata Rave. Clinovo is able to tailor the Rave EDC plaZormthrough custom funcOons to meet your specific protocol requirements and achievefasterstudybuild.

 MedidataRavecerOfiedstudybuilders

 AgileimplementaOon

 BackendintegraOon StudymigraOon

 Industrystandardbasedarchitecture

 UseracceptancetesOng

 Globallibraryset‐up CustomfuncOonsdevelopment

 ConfiguraOonofuser‐interfaceandworkflow

 eCRFdesignandcustomizaOon

 User‐controlledaccesstoeCRFs/dataentry ComplexeditchecksconfiguraOonandverificaOon

ANEXPERIENCEDTEAM FULLCUSTOMIZATION

 BestofbreedtechnologyandindustryexperOse

 Localdedicatedteamofexperts

 ExpertinFDAstandardsandguidelines

 21CFRPart11validaOon

 Excellentdataaccuracyandintegrity

 CustomizedplaZormdesign

Regulatory requirements have significantly lengthened andcomplicated clinical trials, resulOng inan11%annual rise in clinicaltesOngexpensesanddelaysinFDAsubmission.As a result, sponsors are looking for efficient technology soluOons,suchasEDC,toavoidhumanerrorduringdatacollecOonandassessclinicaldataqualityatanearlierstage.ImplemenOng a new EDC system requires in‐house technologyexperOse that canproveOmeconsumingandexpensive toacquire.YourlocalClinovoteamwillguideyouthroughtheenOreset‐upandimplementaOonprocesstohelpyousignificantlyreduceyourOmetomarket.

Clinovo is your leading edge Clinical Data SoluOons Provider. We provide local medical device, biotechnology andpharmaceuOcalcompanieswithfullservicebiometrics,suchasClinicalDataManagement,ElectronicDataCapture,BiostaOsOcs,andCDISCmapping.By leveragingbest‐of‐breed technology,wedevelopand customize turnkey soluOons that accelerate theclinicaltrialprocessandspeedupregulatoryreview.