clincapture demo webinar
DESCRIPTION
ClinCapture demo WebinarTRANSCRIPT
Clinovo1208 E. Arques Avenue, Suite 114
Sunnyvale, CA 94085
+1 800 987 6007
www.clinovo.com
Open Source Technologies for Clinical Trials
Live demo of
Free Webinar – Wednesday February 8th, 9 AM PST
2
Proprietary and confidential
Open Source Technologies for Clinical Trials
February 8th, 2012
Today’s Speaker
3
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:
�Medidata Rave® Advanced Use
�Open Source For Clinical Trials
�CDISC® Data Conversion
�Adaptive Clinical Trials
4
Proprietary and confidential
Open Source Technologies for Clinical Trials
February 8th, 2012
� What is open source?
� Benefits and challenges of open source for clinical trials
� Live demo of ClinCapture
� Q&A
Today’s Agenda
5
Proprietary and confidential
Open Source Technologies for Clinical Trials
February 8th, 2012
� 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?
6
Proprietary and confidential
Open Source Technologies for Clinical Trials
February 8th, 2012
� 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
7
Proprietary and confidential
Open Source Technologies for Clinical Trials
February 8th, 2012
Concerns
� No vendor responsible for open source product
� Higher cost of validation
� Licenses are complicated to understand and follow
� Potential push-back from QA
8
Proprietary and confidential
Open Source Technologies for Clinical Trials
February 8th, 2012
Why Open Source for clinical trials?
More Flexible
Lower cost
Faster
Ultimately accelerates
medical innovation
� Paper-based methods are error-prone
� Proprietary systems for clinical data management are too expensive
Open source
tools
�
�
�
9
Proprietary and confidential
Open Source Technologies for Clinical Trials
February 8th, 2012
� 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
10
Proprietary and confidential
Open Source Technologies for Clinical Trials
February 8th, 2012
Open Source EDC platforms
Open-source EDC Proprietary EDC
Cost of License Free
Vendor lock-in Multiple vendorsMaintenance, 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.
11
Proprietary and confidential
Open Source Technologies for Clinical Trials
February 8th, 2012
12
Proprietary and confidential
Open Source Technologies for Clinical Trials
February 8th, 2012
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
13
Proprietary and confidential
Open Source Technologies for Clinical Trials
February 8th, 2012
ClinCapture Workflow
Build Study
Design eCRFsConfigure Visits/EventsCode Edit ChecksCreate SitesCreate UsersPublish Study
Capture Data
Add SubjectsSchedule Visits/Events Enter Data in eCRFsOptional double data entry
Resolve
Discrepancies
Open QueryPropose Resolution Answer QueryReview QueryClose Query
Monitor & Manage
Data
Verify Source DataeSign CRFs and casebookReview Audit Log Import/Export DataAmend Study eCRFsLock database
14
Proprietary and confidential
Open Source Technologies for Clinical Trials
February 8th, 2012
ClinCapture Demo
PRO study: A prospective, multi-center, single-arm, medical device study. The objective is to determinethe 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
15
Proprietary and confidential
Open Source Technologies for Clinical Trials
February 8th, 2012
Q&A
16
Proprietary and confidential
Open Source Technologies for Clinical Trials
February 8th, 2012
Contact us
Upcoming webinar:
CDISC® SDTM Conversion – February 29th, 2012Live demo of CDISC® Express, our free CDISC SDTM mapping tool
@clinovo