Sanofi The ENCORE Platform - DitaExchange · documents and summaries across product development...
Transcript of Sanofi The ENCORE Platform - DitaExchange · documents and summaries across product development...
Sanofi – The ENCORE Platform Enterprise Content Optimization& Reuse Engine
Joan Affleck - Head, Clinical Documentation
Bhanu Bahl – Business Project Manager
Vasu Ranganathan – Senior Consultant
2012
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CRUISE Program Charter
Delivery of a highly adaptable and accountable service based platform enabled by innovative knowledge management tools and efficient, reusable processes.
Structured authoring and re-use of both content and processes as well as separating content from presentation while proactively ensuring compliance
Reduction of the effort required to prepare, compile and analyse content and documents through a synergy of optimized processes and enabling technology proactively scoped for value by a defined service catalog
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Approach – CRUISE Program implementation
Agile program execution for
all activities
Agile playbook and tools
facilitate common goals and
improve information sharing
Key benefits:
Delivers functionality and business
value incrementally, in time-boxed
releases
Create a Structured Clinical
content Hub
Produces results in faster time
Improves risk mitigation by
correcting direction iteratively
Fosters innovation between the
broader team
Improves team collaboration and
ownership
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Clinical Documentation at Sanofi
• Integral department of Clinical Science and Operations platform
• Highly flexible global team of document specialists
• Service focus: state of the art expertise and resources for
– management of clinical content
– strategic production of submission-ready clinical documents
– disclosure of clinical study protocols and results
• Goals – Innovative and strategic solutions
for global life-cycle documentation
– Accelerate and improve document preparation
– Anticipate strategic documentation roadmap
– Meet documentation needs across product life cycle
– Build a structured library of product-specific content for intelligent reuse
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Clinical Documentation – Timeline
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Business Drivers
ENSURE CONSISTENCY WITHIN THE ORGANIZATION AND BETWEEN PUBLIC DISCLOSURE AND REGULATED REPORTS (NDA, IND, CTA, PSUR...) AGAINST DATABASES
REDUCE CYCLE TIMES, ENABLE EARLIER AND MORE EFFECTIVE DECISION-MAKING AROUND CLINICAL DEVELOPMENT PROGRAMS, AND REDUCE TIME TO MARKET
QUICKLY ASSESS VALUE AND NON-VALUE ADD ACTIVITIES AND MANAGE THE SOURCING OF THOSE ACTIVITIES WITHIN THE CAPABILITIES PORTFOLIOS BALANCING FIXED AND VARIABLE COSTS
SHARE KNOWLEDGE BY MOVING TOWARD REUSABLE COMPONENTS OF INFORMATION THAT CAN BE MANAGED AND REUSED ACROSS PUBLICATIONS, DEPARTMENTS AND AUDIENCES.
BUSINESS DRIVERS
Deliver a highly adaptable and accountable service based platform enabled by innovative knowledge management tools and efficient, reusable processes.
Perform structured authoring by enabling re-use of both content and processes as well as separating content from presentation while proactively ensuring compliance
Reduce the effort required to prepare, compile and analyse content and documents
Lead, change and innovate within the transforming enterprise
PROGRAM PRINCIPLES
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Program Impact
Situation
Refine submission documents preparation and
review processes
Structure scientific information delivered
throughout development to all stakeholders
Define process for preparation of source
documents and summaries across product
development including identification of
process ownership of various documents
Refine CTA/IND review process
Develop content re-use and structured
authoring information system tool
Manage content and ongoing updates of
CTA/CTD documents
Automate publishing of documents into
different formats
Transform to a service based model in Clinical
Documentation as an enabling team
Defects
Unnecessary workload and time
delays
Study reports & appendixes
finalized late / not e-compliant
CTD lack of scientific
consistency
No standard methodology nor
tools for data collection &
aggregation
Lack of structure in CTA/CTD
document review process leading
to long review cycles
Multiple iterations
Recurrent remarks at different
stages of review
1
2 B
A
Over
processing
CTA = Clinical Trial Application, including Investigational New Drug (IND). This remarks applies to the entire document CTD = Common Technical Dossier HA = Health Authorities
C
Impact: Increased Quality, Faster and Cheaper
Change
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What does content reuse look like?
ENTERPRISE CONTENT
Description • Title • Number • ...
Analysis plan
• ... • ...
Results
• ... • ...
Administrative information
• ... • ...
Study report
Appendices
Body
DALA
DRMP
IB
CVD
Pediatric Plan
...
CTD
CTA
Appendices
Section 5
Protocol
Protocol (pdf format)
Disclosure (XML format)
Online protocol (html)
clinicaltrial.gov EMEA
Investigators online help ICTM
Investigators Ethics committees Health authorities
CTA = Clinical Trial Application, CTD = Common Technical Dossier, DALA = Drug Abuse Liability Assessment, DRMP = Development Risk Management Plan, CVD = Core Value Dossier, IB = Investigational Brochure, ICTM = International Clinical Trial Manager
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• Release 1 2011 – baseline platform in place • Extended Synopsis and Protocol Authoring basic service
• Begin Change Management
• Release 2 - Feb 2012 – expand capabilities • Improve Information model and search
• Start operational use of system for authoring
• Continue Change Management
• Release 3 – In progress • Continue authoring of Synopsis and Protocol (several documents
authored in platform)
• Narratives Service – stage 1
• Operational use of system for Narratives
• Continue configuration/ implementation of usability features
Program Status
<<Your Logo>> Business Challenges
• REUSE: Value and benefits increase as content is repurposed across the product and clinical development lifecycle. How to author for reuse?
• DELIVERY: Program implementation iterative based on business priorities, capacity of business to absorb the changes
• PROCESS: Process simplification needs to be incremental and aligned with the SCM roadmap
• STANDARDS: Alignment with enterprise and industry standards namely the HL7, SDTM for narratives
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<<Your Logo>> Technical Challenges
• ENVIRONMENT: WORD and SharePoint 2010 - First at sanofi ; K2 integration
• DELIVERY: Fast-paced Agile approach to delivery - Quarterly releases stretch the testing resources and capabilities
• PERFORMANCE: Complex data in contents poses performance and optimization needs especially in the Publishing engine
• INTEGRATION: real-time Data integration needs in embedded content to other sanofi systems like biostatistics tables, document management systems
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<<Your Logo>> Key SCM Principles
• Improve efficiencies – Separating content from context and presentation
• Improve quality, consistency and accuracy – Reuse of content across deliverables in the product or study
lifecycle
• Ability to incorporate data, un-structured and structured content into output
• Component Content Management – Content managed and stewarded at a more granular level -
Lifecycle policy applied to content across the product or study lifecycle
– Governance/ stewardship of components
• Improve traceability – linkage to outputs – Improve managing changes
– Visibility to impacts of change
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Project Acknowledgements
• Core team leads: – Joan Affleck: Sponsor – Michael Robbins/ Bhanu Bahl: Program Manager – Mitzi Allred: New Services/ Information Design – Mike Kinney/ Sandrine Avaro-Coutant: Product Development – Cynthia Deparis/ Beth Brooks: Change Management – Product Vendor: DITA Exchange/ MicroSoft – Development Partner: ArborSys Group – Mary McKenna, Sarah Larson: Operations/ Engagement
Managers – Clinical Documentation/ CSDs: Users and support team
members who have been critical to roll-out and operationalization
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Technical Solution and Demo
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Intelligent Content Framework
• SharePoint & Office 2010
• DITA Exchange
End-to-end XML Content Component Management System
Single-source-publishing via style sheets
Authoring Interfaces
Word 2010 with DE Plug-in for OXML to DITA XML
Word 2010 “XML interface” for Technical Experts
Re-using existing SharePoint standard features: Sites, Lists, Libraries, Lifecycle, Workflow, Versioning, BDC, Managed Metadata, Search
Third-party Workflow and Rules Engine
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Maps, - Viewed and edited through a Editor interface (Web part)
DITA Exchange – Manage Maps, Topics, Authoring
Maps, Topics, Publications – Managed in libraries
Maps, - Topics edited through a Word Editor interface (Web part)
<<Your Logo>> SCM Key Needs
• Search and Consuming Component Content – Improved and easy ways to search for information
– Easy ways for assembly/ consumption of component content during the output configuration, as well as authoring and review/ approval processes
2012