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Open Source Technologies for Clinical Trials Live demo of Free Webinar – Wednesday February 8th, 9 AM PST

Clinovo 1208 E. Arques Avenue, Suite 114 Sunnyvale, CA 94085 contact@clinovo.com +1 800 987 6007 www.clinovo.com


Today’s Speaker

Open Source Technologies for Clinical Trials February 8th, 2012 Proprietary and confidential

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Clinovo’s free webinar series Every month, Clinovo hosts several webinars covering various topics: Medidata Rave® Advanced Use Open Source For Clinical Trials CDISC® Data Conversion Adaptive Clinical Trials

Open Source Technologies for Clinical Trials February 8th, 2012 Proprietary and confidential

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Today’s Agenda  What is open source?  Benefits and challenges of open source for clinical trials  Live demo of ClinCapture  Q&A

Open Source Technologies for Clinical Trials February 8th, 2012 Proprietary and confidential

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What is Open Source?  Free distribution  Code available to anyone to use, support or enhance  Derived work  Integrity of the source code  Many types of open source licenses

Open Source Technologies for Clinical Trials February 8th, 2012 Proprietary and confidential

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Benefits  Provide state-of-the-art, cost-effective solutions  No vendor lock-in  Chance to influence features roadmap  Large community to maintain and enhance code  Flexible support options

Open Source Technologies for Clinical Trials February 8th, 2012 Proprietary and confidential

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Concerns  No vendor responsible for open source product  Higher cost of validation  Licenses are complicated to understand and follow  Potential push-back from QA

Open Source Technologies for Clinical Trials February 8th, 2012 Proprietary and confidential

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Why Open Source for clinical trials? 

Paper-based methods are error-prone



Proprietary systems for clinical data management are too expensive

 

Ultimately accelerates medical innovation

Faster



Lower cost

More Flexible

Open source tools

Open Source Technologies for Clinical Trials February 8th, 2012 Proprietary and confidential

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Open Source Systems in Clinical Trials        

Operating Systems: RedHat, Suse, UNIX Languages: Java, C/++, PhP, Python, PERL Web servers : Apache, Tomcat Databases : MySQL, PostgreSQL, Sleepycat Productivity Tools: OpenOffice, Mozilla Business Intelligence : Pentaho, JasperSoft Collaboration Portals : Alfresco Systems Integration: Intalio, Talend



EDC : OpenClinica, Yale TrialDB, ClinCapture



CDISC : OpenCDISC, CDISC Express



Electronic health or medical record (OpenEMR)



Clinical research: Labkey Server



Analysis (R project)



DICOM Imaging : OsiriX



Health Information Exchange : Misys

Open Source Technologies for Clinical Trials February 8th, 2012 Proprietary and confidential

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Open Source EDC platforms 

A growing number of users: OpenClinica has a community of over 14,000 developers.



Same benefits as proprietary EDC systems, but at a lower cost.

Open-source EDC Cost of License

Free

Vendor lock-in

Multiple vendors

Hosting

At sponsor or vendor

Proprietary EDC

Maintenance, support, upgrades

Typically hosted by vendor

Database programming Features 21 CFR Part 11 compliance

Open Source Technologies for Clinical Trials February 8th, 2012 Proprietary and confidential

Depends on vendor

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Open Source Technologies for Clinical Trials February 8th, 2012 Proprietary and confidential

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A powerful alternative to costly, proprietary EDC systems  Based on OpenClinica #1 Open source EDC  Over 14,000 developers and 400 sponsors  No license fee  User-friendly Web system  Fully validated  No vendor lock-in

Open Source Technologies for Clinical Trials February 8th, 2012 Proprietary and confidential

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ClinCapture Workflow Build Study

Design eCRFs Configure Visits/Events Code Edit Checks Create Sites Create Users Publish Study

Capture Data

Add Subjects Schedule Visits/Events Enter Data in eCRFs Optional double data entry

Resolve Discrepancies Open Query Propose Resolution Answer Query Review Query Close Query

Monitor & Manage Data Verify Source Data eSign CRFs and casebook Review Audit Log Import/Export Data Amend Study eCRFs Lock database

Open Source Technologies for Clinical Trials February 8th, 2012 Proprietary and confidential

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ClinCapture Demo PRO study: A prospective, multi-center, single-arm, medical device study. The objective is to determine the effectiveness (revascularization rate of large vessel in ischemic stroke patients) and the safety of the device.

PRO Study (50 subject target enrollment)  1 Data Manager  1 Monitor

SFO (30 subject target enrollment) 1 Investigator  1 CRC 

LAX (20 subject target enrollment)  1 Investigator  1 CRC

Open Source Technologies for Clinical Trials February 8th, 2012 Proprietary and confidential

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Q&A

Open Source Technologies for Clinical Trials February 8th, 2012 Proprietary and confidential

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Contact us

Marc.Desgrousilliers@clinovo.com

Leslie.kolman@clinovo.com

Upcoming webinar: CDISC® SDTM Conversion – February 29th, 2012 Live demo of CDISC® Express, our free CDISC SDTM mapping tool

@clinovo Open Source Technologies for Clinical Trials February 8th, 2012 Proprietary and confidential

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ClinCapture demo Webinar  

ClinCapture demo Webinar

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