Open Source Technologies for Clinical Trials

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 Live demo of

Free Webinar – Wednesday March 21st, 9 AM PST

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Proprietary and confidential

Open Source Technologies for Clinical Trials February 8th, 2012

Clinovo’s free webinar series

Every month, Clinovo hosts several webinars covering various topics:

CDISC® Conversion Made Easy with CDISC Express

Medidata Rave® Advanced Use

Open Source Technologies For Clinical Trials

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Today’s Speaker

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What is open source?

Benefits and challenges of open source for clinical trials

Live demo of ClinCapture

Q&A

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

More Flexible

Lower cost

Faster

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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Open Source EDC platforms

Open-source EDC Proprietary EDC

Cost of License

Free

Vendor lock-in

Multiple vendors Maintenance, support,

upgrades

Hosting

At sponsor or vendor

Typically hosted by vendor

Database programming

Features

21 CFR Part 11 compliance Depends on vendor

A growing number of users: OpenClinica has a community of over 14,000 developers.

Same benefits as proprietary EDC systems, but at a lower cost.

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A powerful alternative to costly, proprietary EDC systems

Based on OpenClinica #1 Open source EDC

Over 14,000 developers and 400 sponsors

No license fee

User-friendly Web system

Fully validated

No vendor lock-in

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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.

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

http://ocdemo.clinovo.com/

http://demo.clincapture.clinovo.com/



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Q&A

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Contact us

Upcoming webinar:

CDISC® Conversion made easy with CDISC® Express – March 28th, 2012 Live demo of CDISC® Express, our free CDISC SDTM mapping tool

[email protected]

@clinovo

[email protected]

Open Source Technologies for Clinical Trials

Documents

Transcript of Open Source Technologies for Clinical Trials