Open Source Technologies for Clinical Trials
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Today’s Speaker
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Today’s Agenda What is open source?
Benefits and challenges of open source for clinical trials Live demo of ClinCapture
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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
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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
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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
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Why Open Source for clinical trials?
Ultimately accelerates medical innovation
State-of-the-art
Lower cost
No vendor lock-in
Open source tools
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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
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ClinCapture and Commercial EDC systems
Cost of License
Free
Vendor lock-in
Multiple vendors
Maintenance, support, upgrades
21 CFR Part 11 compliance
Data Hosting eCRF design
At Client or
Close to paper CRF to minimize site training and human errors
Typically hosted by vendor Unintuitive and error-prone
Database programming Advanced Features - Web services - CTMS/Core Lab/ePRO data integration - Drag & drop adhoc reporting Customization
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A powerful alternative to costly, proprietary EDC systems Intuitive and easy to use Fully validated
No vendor lock-in No license fee Based on OpenClinica #1 Open source EDC Over 14,000 developers and 400 sponsors
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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
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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
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Contact us
Marc.Desgrousilliers@clinovo.com
Open Source Technologies for Clinical Trials Property of Clinovo
Joshua.Elvert@clinovo.com
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