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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
Free Webinar – Thursday August 25th, 9 AM PST
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Open Source Technologies for Clinical Trials August 25th, 2011
Mark Burns
Clinical Database Specialist
Intuitive Surgical
Marc Desgrousilliers
VP of Technical Operations
Clinovo
Today’s Speakers
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Open Source Technologies for Clinical Trials August 25th, 2011
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
Today’s Agenda
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Open Source Technologies for Clinical Trials August 25th, 2011
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Open Source Technologies for Clinical Trials August 25th, 2011
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
What is Open Source?
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Open Source Technologies for Clinical Trials August 25th, 2011
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
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Open Source Technologies for Clinical Trials August 25th, 2011
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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Open Source Technologies for Clinical Trials August 25th, 2011
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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Open Source Technologies for Clinical Trials August 25th, 2011
Mark Burns Clinical Database Specialist at Intuitive Surgical
Best practices for a successful implementation
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Open Source Technologies for Clinical Trials August 25th, 2011
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)
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Open Source Technologies for Clinical Trials August 25th, 2011
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
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Open Source Technologies for Clinical Trials August 25th, 2011
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?
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Open Source Technologies for Clinical Trials August 25th, 2011
Preliminary Investigation of Vendor/ClinCapture
Check references for previous clients
Confirm SOPs are up to standard
Check previous clients impressions with ClinCapture
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Open Source Technologies for Clinical Trials August 25th, 2011
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)
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Open Source Technologies for Clinical Trials August 25th, 2011
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
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Open Source Technologies for Clinical Trials August 25th, 2011
Training
User training
Vendor training presentations
Administrator training
Development training
Allows for internal development going forward
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Open Source Technologies for Clinical Trials August 25th, 2011
Support
Agreement with vendor for ongoing tech support as needed
Don’t need end user support currently
Ticket approach for technical developmental support issues
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Open Source Technologies for Clinical Trials August 25th, 2011
Results
Initial study
Approximately 3 months from vendor qualification to end of validation
Since then 4 studies have been implemented and validated
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Open Source Technologies for Clinical Trials August 25th, 2011
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Open Source Technologies for Clinical Trials August 25th, 2011
Contact us
Marc Desgrousilliers
VP of Technical Operations
Mark Burns
Clinical Database Specialist
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
