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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