Open Source Technologies for Clinical Trials Free Webinar – Tuesday July 19th, 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 Speakers
Eric Morrie Manager, Clinical Programming Abbott Vascular
Marc Desgrousilliers VP of Technical Operations Clinovo
Open Source Technologies for Clinical Trials July 19th, 2011 Proprietary and confidential
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Today’s Agenda What is open source? Key systems used in clinical trials Benefits and challenges of open source for clinical trials Eric Morrie, Manager, Clinical Programming at Abbott Vascular : Best practices for a successful implementation Q&A
Open Source Technologies for Clinical Trials July 19th, 2011 Proprietary and confidential
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Open Source Technologies for Clinical Trials July 19th, 2011 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 Major organizations
Open Source Technologies for Clinical Trials July 19th, 2011 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
EDC : OpenClinica, Yale TrialDB
CDISC : OpenCDISC, CDISC Express
Business Intelligence : Pentaho, JasperSoft
DICOM Imaging : OsiriX
Health Information Exchange : Misys
Collaboration Portals : Alfresco
Systems Integration: Intalio, Talend
Open Source Technologies for Clinical Trials July 19th, 2011 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 July 19th, 2011 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 July 19th, 2011 Proprietary and confidential
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Eric Morrie Manager, Clinical Programming at Abbott Vascular Best practices for a successful implementation
Open Source Technologies for Clinical Trials July 19th, 2011 Proprietary and confidential
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Experience with Open Source University of Rochester Medical Center
Academic research and coordinating site Orphan drug, registry or low budget trials
Bausch & Lomb
Replacing custom written systems Metrics and trending
Abbott Vascular
Evaluating Open Source options
Open Source Technologies for Clinical Trials July 19th, 2011 Proprietary and confidential
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Clinical Research Created by Akaza Research Medical device studies at internal clinic Replaced MS Access based application Very high level of standards Typical trial runs 1 day to 1 week 1 week lead time for builds
Open Source Technologies for Clinical Trials July 19th, 2011 Proprietary and confidential
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Business Intelligence
Analysis and trending of product complaints Assurx CATSWeb system Modeling, Reporting, and ETL suite
Open Source Technologies for Clinical Trials July 19th, 2011 Proprietary and confidential
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Unique Subject ID Encryption utilities Generate a Subject ID to be used across trials Secure web based Subject facing
Open Source Technologies for Clinical Trials July 19th, 2011 Proprietary and confidential
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CT/MRI Image Indexing
Image reconciliation and accounting Query triggered for missing images
Open Source Technologies for Clinical Trials July 19th, 2011 Proprietary and confidential
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Why Open Source? Cost
Traditional - Pay for software/Pay for services Open Source – Pay for services
Flexibility
To replace specialized systems To link to other systems
Speed
Slim implementations Streamlined development
Open Source Technologies for Clinical Trials July 19th, 2011 Proprietary and confidential
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Weaknesses of Open Source Support
Need to select partners or internalize
Technical demands
Requires skilled personnel
Code branching
Changes you don’t share may haunt you
Open Source Technologies for Clinical Trials July 19th, 2011 Proprietary and confidential
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Industry Trends Favor Open Source Outsourcing
Hosted validated environments
Data integration
Open architecture / standards
Lower costs
No license fees
Faster
Designed from the ground up for simplicity
Open Source Technologies for Clinical Trials July 19th, 2011 Proprietary and confidential
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Best Practices Understand your requirements Know your limitations Documentation is essential Processes will change Audit yourself as a vendor
Open Source Technologies for Clinical Trials July 19th, 2011 Proprietary and confidential
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Open Source Technologies for Clinical Trials July 19th, 2011 Proprietary and confidential
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Contact us Marc Desgrousilliers
Eric Morrie
VP of Technical Operations
Manager, Clinical Programming
marc.desgrousilliers@clinovo.com
Eric.Morrie@av.abbott.com
Upcoming webinars Medidata Rave Custom Functions July 20th, 9 AM PST CDISC Express Demo
July 28th, 9 AM PST
www.clinovo.com Follow us on twitter @clinovo Open Source Technologies for Clinical Trials July 19th, 2011 Proprietary and confidential
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