Open Source EDC

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Visit our website: www.clinovo.com Contact us today to accelerate your clinical trial: [email protected] OUR ENHANCEMENTS TO #1 OPEN SOURCE EDC Sunnyvale Office +1 800 987 6007 Clinovo EDC SoluMons ABOUT CLINOVO San Diego Office +1 760 579 7352 Full system validaMon IntuiMve plaWorm navigaMon CustomizaMon to match your protocol Complex edit checks Password and account security CRF design & layout Clinovo believes in innovaMon. As such, we have been a strong proponent of open source technologies. To help sponsors conduct faster, cost‐effecMve clinical trials, we offer ClinCapture, a proven web‐based open source EDC system. Fully customizable to your study, ClinCapture delivers the same benefits as proprietary soluMons, but without the license fees. HIGHER FUNCTIONALITY AT LOWER COSTS Regulatory requirements have significantly lengthened and complicated clinical trials, resulMng in an 11% annual rise in clinical tesMng expenses and delays in FDA submission. As a result, sponsors are looking for efficient technology soluMons, such as EDC, to avoid human error during data collecMon and assess clinical data quality at an earlier stage. ImplemenMng a new EDC system requires in‐house technology experMse that can prove Mme‐consuming and expensive to acquire. Your local Clinovo‐team will guide you through the enMre set‐up and implementaMon process to help you significantly reduce your Mme to market. OUR EDC EXPERTISE Experienced with all major EDC plaWorms Expert in FDA standards and guidelines Best‐of‐breed technology and unique domain experMse 21 CFR Part 11 compliance Helpdesk system for any EDC plaWorm InnovaMve clinical systems developed in‐house No license fee Based on #1 open source EDC plaWorm: over 11,000 developers and users worldwide User‐friendly and configurable web‐based interface Vendor independent Seamless access to your clinical data Clinovo is your leading edge Clinical Data SoluMons Provider. We provide local medical device, biotechnology and pharmaceuMcal companies with full service biometrics, such as Clinical Data Management, Electronic Data Capture, BiostaMsMcs, and CDISC mapping. By leveraging best‐of‐breed technology, we develop and customize turn key soluMons that accelerate the clinical trial process and speed up regulatory review.

description

Fully customizable to your study, ClinCapture is an open source EDC system that delivers the same benefits as proprietary solutions without the license fees.

Transcript of Open Source EDC

Page 1: Open Source EDC

Visitourwebsite:www.clinovo.com

Contactustodaytoaccelerateyourclinicaltrial:[email protected]

OURENHANCEMENTSTO#1OPENSOURCEEDC 

SunnyvaleOffice+18009876007

ClinovoEDCSoluMons

ABOUTCLINOVO

SanDiegoOffice+17605797352

 FullsystemvalidaMon

 IntuiMveplaWormnavigaMon

 CustomizaMontomatchyourprotocol

 Complexeditchecks

 Passwordandaccountsecurity

 CRFdesign&layout

Clinovo believes in innovaMon. As such, we have been a strongproponent of open source technologies. To help sponsors conductfaster, cost‐effecMve clinical trials, we offer ClinCapture, a provenweb‐based open source EDC system. Fully customizable to yourstudy, ClinCapture delivers the same benefits as proprietarysoluMons,butwithoutthelicensefees.

HIGHERFUNCTIONALITYATLOWERCOSTS

Regulatory requirements have significantly lengthened andcomplicated clinical trials, resulMng inan11%annual rise in clinicaltesMngexpensesanddelaysinFDAsubmission.As a result, sponsors are looking for efficient technology soluMons,suchasEDC,toavoidhumanerrorduringdatacollecMonandassessclinicaldataqualityatanearlierstage.ImplemenMng a new EDC system requires in‐house technologyexperMse that canproveMme‐consumingandexpensive to acquire.YourlocalClinovo‐teamwillguideyouthroughtheenMreset‐upandimplementaMonprocesstohelpyousignificantlyreduceyourMmetomarket.

OUREDCEXPERTISE

 ExperiencedwithallmajorEDCplaWorms

 ExpertinFDAstandardsandguidelines

 Best‐of‐breedtechnologyanduniquedomainexperMse

 21CFRPart11compliance

 HelpdesksystemforanyEDCplaWorm

 InnovaMveclinicalsystemsdevelopedin‐house

 Nolicensefee

 Basedon#1opensourceEDCplaWorm:

over11,000developersandusersworldwide

 User‐friendlyandconfigurableweb‐basedinterface

 Vendorindependent

 Seamlessaccesstoyourclinicaldata

Clinovo is your leading edge Clinical Data SoluMons Provider. We provide local medical device, biotechnology andpharmaceuMcal companies with full service biometrics, such as Clinical Data Management, ElectronicData Capture, BiostaMsMcs, and CDISCmapping. By leveraging best‐of‐breed technology,we develop and customizeturnkeysoluMonsthatacceleratetheclinicaltrialprocessandspeedupregulatoryreview.