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2012
Sanofi – The ENCORE Platform
Enterprise Content Optimization& Reuse Engine
Joan Affleck - Head, Clinical Documentation
Bhanu Bahl – Business Project Manager
Vasu Ranganathan – Senior Consultant
CRUISE Program Charter
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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
Key benefits:
Delivers functionality and business
value incrementally, in time-boxed
releases
Create a Structured Clinical
content Hub
Produces results in faster time
Agile program execution for
all activities
Agile playbook and tools
facilitate common goals and
improve information sharing
Improves risk mitigation by
correcting direction iteratively
Fosters innovation between the
broader team
Improves team collaboration and
ownership
Clinical Documentation at Sanofi
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• 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
Clinical Documentation – Timeline
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Business Drivers
BUSINESS DRIVERS
ENSURE CONSISTENCY WITHIN THE ORGANIZATION AND
BETWEEN PUBLIC DISCLOSURE AND REGULATED REPORTS
(NDA, IND, CTA, PSUR...) AGAINST DATABASES
QUICKLY ASSESS VALUE AND NON-VALUE ADD ACTIVITIES AND
MANAGE THE SOURCING OF THOSE ACTIVITIES WITHIN THE
CAPABILITIES PORTFOLIOS BALANCING FIXED AND VARIABLE
COSTS
REDUCE CYCLE TIMES, ENABLE EARLIER AND MORE EFFECTIVE
DECISION-MAKING AROUND CLINICAL DEVELOPMENT
PROGRAMS, AND REDUCE TIME TO MARKET
SHARE KNOWLEDGE BY MOVING TOWARD REUSABLE
COMPONENTS OF INFORMATION THAT CAN BE MANAGED
AND REUSED ACROSS PUBLICATIONS, DEPARTMENTS AND
AUDIENCES.
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PROGRAM PRINCIPLES
 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 Impact
Situation
1
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
2
Lack of structure in CTA/CTD
document review process leading
to long review cycles
Multiple iterations
Recurrent remarks at different
stages of review
Defects
Over
processing
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Change
A
B
C
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
Impact: Increased Quality, Faster and Cheaper
CTA = Clinical Trial Application, including Investigational New Drug (IND). This remarks applies to the entire document
CTD = Common Technical Dossier
HA = Health Authorities
What does content reuse look like?
DALA
Protocol
ENTERPRISE CONTENT
Description
• Title
• Number
• ...
Analysis plan
• ...
• ...
Protocol
(pdf format)
Investigators
Ethics committees
Health authorities
DRMP
CVD
Investigators online help
ICTM
IB
Online protocol (html)
Pediatric Plan
Disclosure
(XML format)
Results
• ...
• ...
Administrative information
• ...
• ...
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clinicaltrial.gov
EMEA
...
CTA
CTD
Study report
Appendices
Body
Appendices
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
Section 5
Program Status
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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
Business Challenges
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• 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
10
Technical Challenges
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• 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
11
Key SCM Principles
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• 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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DITA Exchange – Manage Maps, Topics, Authoring
Maps, Topics, Publications –
Managed in libraries
Maps, - Topics edited through a Word Editor
interface (Web part)
Maps, - Viewed and edited through a Editor
interface (Web part)
SCM Key Needs
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• 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