Open Source Technologies for Clinical Trials Free Webinar – Thursday August 25th, 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 Marc Desgrousilliers VP of Technical Operations
Clinovo
Mark Burns Clinical Database Specialist Intuitive Surgical
Open Source Technologies for Clinical Trials August 25th, 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 Mark Burns, Clinical Database Specialist at Intuitive Surgical: Best practices for a successful implementation Q&A
Open Source Technologies for Clinical Trials August 25th, 2011 Proprietary and confidential
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Open Source Technologies for Clinical Trials August 25th, 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 August 25th, 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 August 25th, 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 August 25th, 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 August 25th, 2011 Proprietary and confidential
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Mark Burns Clinical Database Specialist at Intuitive Surgical Best practices for a successful implementation
Open Source Technologies for Clinical Trials August 25th, 2011 Proprietary and confidential
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Experience with Electronic Data Systems St. Jude Medical
User Interface development Data modeling Data system administration
Intuitive Surgical
Data collection systems User interface development MS Access Salesforce.com EDC system evaluation (open source vs license model)
Open Source Technologies for Clinical Trials August 25th, 2011 Proprietary and confidential
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Clinical Requirements Database location in-house Medical device studies at external clinics
Multiple studies (small patient numbers)
IDE to post market studies
Short lead time to begin studies
Open Source Technologies for Clinical Trials August 25th, 2011 Proprietary and confidential
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Why ClinCapture? No license fees for software
Especially advantageous with many small studies
In-house technical capabilities
Allows for internal development for new studies
Validation
Vendor demonstrated excellent validation experience with ClinCapture
Stability
Good stability over mid-term Long term is a bit hazy Will Akaza continue with open source as main component?
Open Source Technologies for Clinical Trials August 25th, 2011 Proprietary and confidential
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Preliminary Investigation of Vendor/ClinCapture Check references for previous clients Confirm SOPs are up to standard Check previous clients impressions with ClinCapture
Open Source Technologies for Clinical Trials August 25th, 2011 Proprietary and confidential
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Strong Internal SOPs/Procedures Qualify new software vendor
Vendor SOP and procedures
Partnership with IT
Really helped with project management for this project
Change control procedures
System in place to allow for validation of new studies after the initial IQ/OQ/PQ validation process (Easier)
Open Source Technologies for Clinical Trials August 25th, 2011 Proprietary and confidential
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Validation IQ/OQ/PQ process
IT/Vendor/Partner/Clinical Affairs worked together closely to implement
Project management
Validation engineer was very helpful in organizing
New studies
Change control system allowed for changes to user interface (no source code changes) to be validated to only the new user interface requirements. Do not need to re-validate Operational/Performance requirements that did not change between studies
Open Source Technologies for Clinical Trials August 25th, 2011 Proprietary and confidential
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Training User training
Vendor training presentations
Administrator training
Development training
Allows for internal development going forward
Open Source Technologies for Clinical Trials August 25th, 2011 Proprietary and confidential
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Support Agreement with vendor for ongoing tech support as needed
Don’t need end user support currently
Ticket approach for technical developmental support issues
Open Source Technologies for Clinical Trials August 25th, 2011 Proprietary and confidential
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Results Initial study
Approximately 3 months from vendor qualification to end of validation
Since then 4 studies have been implemented and validated
Open Source Technologies for Clinical Trials August 25th, 2011 Proprietary and confidential
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Open Source Technologies for Clinical Trials August 25th, 2011 Proprietary and confidential
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Contact us Marc Desgrousilliers
Mark Burns
VP of Technical Operations
Clinical Database Specialist
marc.desgrousilliers@clinovo.com
mark.burns@intusurg.com
Upcoming webinars Implementing Adaptive Clinical Trials October 18th, 9 AM PST Medidata Rave Custom Functions Date TBD
www.clinovo.com Follow us on twitter @clinovo Open Source Technologies for Clinical Trials August 25th, 2011 Proprietary and confidential
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