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 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
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 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
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. 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 Change Defects Over processing 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 B C A 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? Protocol DALA ENTERPRISE CONTENT Description Title Number... Analysis plan...... Protocol (pdf format) Online protocol (html) Disclosure (XML format) Investigators Ethics committees Health authorities Investigators online help ICTM clinicaltrial.gov EMEA DRMP CVD IB Pediatric Plan... Results...... Administrative information...... Study report CTA Appendices CTD Body Appendices Section 5 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
Program Status 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 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 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 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
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
Technical Solution and Demo
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
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 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