the future of oc, rdc, and tms
TRANSCRIPT
The Future of Oracle Clinical, RDC, and TMS
January 10, 2013
Vicky N. Green Director of Client Relations BioPharm Systems
Chris Huang Director of Product Strategy Oracle Health Sciences
Today’s Agenda • Welcome and Introductions
• OC/RDC/TMS Strategy – Oracle Clinical/RDC/TMS Releases
– Product Release Plans and Strategic Development Program
• Amber Release Themes
• Summary and Preview of Features
• Technology and Upgrade Paths
• OC/RDC/TMS Roadmap – Oracle Clinical/RDC Releases
– Product Release Plans
• Q&A
Welcome & Introductions
Vicky N. Green Director of Client Relations BioPharm Systems
• Experience with clinical applications since 1990 – 20+ years with Quintiles, INC Research, CSS Informatics, BioPharm
– Responsible for OC/RDC/TMS-related business development
– Responsible for working with BioPharm hosting and support customers
– Intimate knowledge of the interoperability of clinical applications
– Keen awareness of the clinical technology ecosystem within life sciences companies
Welcome & Introductions
Chris Huang Director of Product Strategy Oracle Health Sciences
• 20+ years of experience in life sciences and software – 11+ years with Oracle
– Responsible for the overall vision and roadmap for eClinical products at Oracle
– Worked at Sanofi, Sandoz, Sparta, OmniComm, Domain Solutions
Welcome & Introductions
Oracle / BioPharm Partnership • BioPharm Systems has been a partner of Oracle Corporation since 1995.
As a Gold Specialized Partner, we consistently demonstrate superior product knowledge, technical expertise, and commitment to Oracle.
• 100s of OC/RDC/TMS implementations, integrations, and upgrades
• Reseller of licenses; member of BPS program
• Various OC/RDC/TMS accelerators available
Welcome & Introductions
Clinical Data Management/EDC Practice Services
Implementations/Upgrades Manage hosted and on-premise implementations of OC, RDC, TMS and JReview
Integrations and Products Build interfaces between OC/RDC/TMS and other clinical/non-clinical systems
Study Setup Assist with all aspects of the study setup process for paper and electronic studies
Application Support Provide dedicated application support team via web, phone, e-mail, remote access, and knowledge base
Training Develop and/or deliver standard and custom training classes and materials, including on-site, remote, and 1:1
Process Guidance Provide insight, advice, assessments, and other solutions for specific CDM/EDC issues
Welcome & Introductions
Clinical Data Management/EDC Practice Products
Accel-Account Manager Easy-to-use clinical account management solution that allows managers of OC/RDC/TMS to create and maintain user accounts
Accel-Copy Solution for copying, migrating and archiving Oracle Clinical studies and global libraries, as well as refreshing study patient data
Simple Forms A light EDC and survey tool that can be used with Oracle Clinical
Accel-NLV Two programs that streamline and enhance the collection of laboratory data in OC/RDC
SOP Packages Procedural documentation that assists organizations with establishing process standards
Validation Packages Comprehensive set of document and templates, ready for customization to meet regulatory and business needs
OC/RDC/TMS Strategy
• OC/RDC/TMS Releases
• Product Release Plans and Strategic Development Program
– Amber Release Themes
– Summary and Preview of Features
– Technology and Upgrade Paths
Oracle Clinical Releases
Delivered ►
June 2009
OC/RDC 4.6 - Nov 2009 - Support for Flexible Studies
• Enhanced DCI Book, • Interval / DCI Rules
- Productivity Enhancements • Multi-Patient DCI Book Assignment • DCI Level Access
- Usability Enhancement • In Page Conditional and
Indicator Branching • Hidden Discrepancies / Questions • Prevent update of ‘other’ discrepancies • Display User Role, Disc ID
- Scalability Enhancements • 24/7 Data Entry and Batch Validation • Improved Middle Tier Scalability • Better handling of intermittent connections
- Updated Technology Stack
OC/RDC 4.6.2 – April 2011 Certifications
• Windows 2008 Server 64 bit (middle tier)
• Oracle AS10gR2 + AS10gR3
• RDBMS 11gR2 (11.2.0.2)
• Forward Patch Porting
•30+ patches/fixes/enhancements
• Enhancement
• Dynamic Thesaurus DVG
• Replication Support
• Standard Replication
• Disconnected Replication
OC/RDC Patchsets 4.6.3 – Sept 2011 4.6.4 – Dec 2011
4.6.5 – Mar 2012
4.6.6 – Aug 2012
2010 Certifications • Oracle Virtual Machine • Active Data Guard • Linux Database Server • Windows 7/Internet Explorer 8 & 9
New Extended Text Feature – Sept 2010 • Support comments up to 10,000 chars
OC/RDC/TMS – 18-24 Month Strategy and Product Focus
• Customer Driven
– Continue to enhance and refine products by working closely with an active SDP and the broader OHSUG community
• Industry Driven Flexibility/Configurability
– Provide organizations greater flexibility to configure OC/RDC/TMS to meet the changing needs of the industry
• Scalability
– Provide the required technical and functional capabilities to support extreme deployments of OC/RDC implementations
• Usability
– Deliver site and sponsor user enhancements that enable greater usability resulting in higher productivity and satisfaction
© 2013 Oracle Corporation – Proprietary and Confidential
Oracle Clinical Amber Release Themes
Maximum Availability and Scalability
– Exadata / RAC support and multi-browser support provides customers with the ability to enable high availability through failover and scalability through support of extreme scalability of Exadata database machines. Increased client level availability through browser independence. Performance improvements moving to RDBMS 11g Optimizer.
– Technology uptake of FMW 11g and RDBMS 11gR2v3 extends support through June 2017 and June 2018, respectively.
Risk-Based Monitoring / Regulatory Compliance
– Provide Partial Source Data Verification features to meet customer needs around reduced / risk-based monitoring guidance. Audit deletes feature to maintain compliance of hard deletes of study data.
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OC/RDC/TMS Amber Release Summary of Target Features
• RDC Onsite
• Partial Source Data Verification (PSDV)
• Identify critical DCIs across the study
• Target percentage or list of patients at each site requiring 100% SDV
• Single Patient Casebook Page
• Verify and Approve Enhancements
• Customizable inclusion/exclusion criteria in Group Verify/Approve dialogs
• Retain status when no data updates, just discrepancy updates
• TMS
• Enhanced drug coding using Who Drug format C
• Auxiliary information pulled from OC/RDC questions
• TMS Support for new Medical Products dictionary – IDMP, aka M5
OC/RDC/TMS Amber Release Target Features (continued) • Oracle Clinical
• PSUB Enhancements
• Store .out and .log files in the database
• Eliminates requirement for user accounts on the RDBMS server
• Audit data for ‘Hard’ deletes
• New back-up tables
• Not surfaced in the user interface
• New Technologies
• RDC Onsite Support for New Browsers
• Firefox, Chrome, Safari (iOS) for RDC Onsite
• Fusion Midddleware (FMW, AS11g)
• RDBMS 11g Optimizer
• RAC
OC/RDC/TMS Amber Release Target Technology
Client Windows XP, Vista, 7 Browsers: IE8, IE9, Firefox, Chrome, Safari (iOS)
(new browsers for RDC Onsite only) Adobe 8, 9, 10 for Annotations
Web Server Windows 2008 SP2 (64-bit) Oracle Virtual Machine (OVM) 3.0 Fusion Midddleware (FMW, AS11g) with:
Application Development Framework (ADF) 11gR2 Forms & Report Server 11gR2 (Premium support through May 2017; improved scalability)
Database Server Oracle Solaris 10, 11 (64-bit) Oracle Enterprise Linux 5.8 / 6.2 with Unbreakable Enterprise Kernel (UEK) 6.2.39 Windows 2008 SP2 (64-bit) RAC Support (Sun and Linux only)
RDBMS Oracle RDBMS 11g (11.2.0.3) with 11g Optimizer
* Items in red indicate a technology or release new to Amber
OC/RDC/TMS Amber Release Targeted Upgrade Paths
• Middle Tier • New installation required
• Database • Oracle Clinical 4.6.x Amber
OC/RDC/TMS Amber Release
• Preview of New Features
– UI Components in RDC Onsite
– Single Patient Casebook
– SDV Plan
– Auxiliary info to support TMS Coding
Links panel on
all pages
(Collapsed by
default on all
pages except
Home)
Shift-click, Ctrl-click
to select rows
Continuously scrolling
horizontal and vertical
scrollbars
One-click icons
for common
actions
Single Casebook page New for Amber
Shift-click, Ctrl-click
to select rows
Continuously scrolling
horizontal and vertical
scrollbars
One-click icons for
common actions
Drill-down links in the
Patient Summary
New! Single Patient
Casebook Page
New UI components in RDC Onsite
Inline message popup message
Combo box for list of values
This is a functional design mock-up and may differ in the final release.
Study-level default selections for Partial SDV
This is a functional design mock-up and may differ in the final release.
Classify VT Omissions
Delivered ► Planned ►
OC/RDC Product Roadmap Future
OC/RDC/TMS 4.6.2 OC/RDC/TMS
Amber Release (Targets) • Maximum Availability / Scalability
• Exadata /RAC
• Fusion MW 11g
• Linux 6
• Multi-browser Support (including iPad)
• RDBMS 11g Optimizer
• Regulatory Requirements
•Partial SDV – form level (support for
reduced/risk-based monitoring)
•Audit Study Data Deletes
• Add’l Enhancements
•Single Patient Casebook
•Retain and Group Verify/Approve
enhancements
•TMS Coding enhancements
OC/RDC/TMS (Candidates)
• Add’l Risk-based Monitoring Support
• Field level SDV
• Documents and Attachments
• Form level attachments
•Technology Stack Maintenance
• Linux on Middle Tier
• Oracle RDBMS
• Single Sign-on
• Productivity
• Copy Study
• Study Export / Import
• Study Archive
• Industry Standards
• CDISC ODM / BRIDG
• Integrations
• IRT, Argus
• Certifications
• Windows 2008 Server 64 bit (middle tier)
• Oracle AS10gR2 + AS10gR3
• RDBMS 11gR2 (11.2.0.2)
• Forward Patch Porting
•30+ patches/fixes/enhancements
• Enhancement
• Dynamic Thesaurus DVG
•Replication Support
• Standard Replication
• Disconnected Replication
Q&A
Closing / Thank you for attending!
• North America/Canada Sales Contact: – Vicky N. Green
– +1 919 462 6395
• Europe/Middle East/Africa Sales Contact: – Rudolf Coetzee
– +44 (0) 1865 910200
• General Inquiries: – [email protected]