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Open Source Technologies for Clinical Trials
Mar 27, 2016
Open Source Technologies for Clinical Trials
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Clinovo 1208 E. Arques Avenue, Suite 114 Sunnyvale, CA 94085 [email protected] +1 800 987 6007 www.clinovo.com
Open Source Technologies for Clinical Trials Demo of
Free on-demand Webinar
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Property of Clinovo Open Source Technologies for Clinical Trials
Discover our on-demand Webinars
Streamlined CDISC Conversion and Reporting
Medidata Rave® Custom Functions
Implementing Adaptive Clinical Trials
CRO Governance Model for Emerging & Virtual Biopharma
And more…
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Property of Clinovo Open Source Technologies for Clinical Trials
Today’s Speaker
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Property of Clinovo Open Source Technologies for Clinical Trials
What is open source?
Benefits and challenges of open source for clinical trials
Live demo of ClinCapture
Today’s Agenda
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Free distribution
Code available to anyone to use, support or enhance
Derived work
Integrity of the source code
Many types of open source licenses
What is Open Source?
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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
Benefits
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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
Open source tools
No vendor lock-in
Lower cost
State-of-the-art
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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
Open Source Systems in Clinical Trials
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
At Client or
Typically hosted by vendor
eCRF design Close to paper CRF to minimize site training and human errors
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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Property of Clinovo Open Source Technologies for Clinical Trials
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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Property of Clinovo Open Source Technologies for Clinical Trials
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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Property of Clinovo Open Source Technologies for Clinical Trials
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.
SFO (30 subject target
enrollment)
1 Investigator
1 CRC
LAX (20 subject target
enrollment)
1 Investigator
1 CRC
PRO Study (50 subject target
enrollment)
1 Data Manager
1 Monitor
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Contact us
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Keep in touch!
CDISC® is a registered trademark of CDISC, Inc. ® indicates USA registration.
SAS and all other SAS Institute Inc. product or service names are registered trademarks or trademarks of SAS
Institute Inc. in the USA and other countries. ® indicates USA registration.
Other brand and product names are trademarks of their respective companies.
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