Sanofi is a leading global pharmaceutical company that focuses on innovative healthcare solutions and serving patients. To get the most revenue out of patent lifespans, the company sought to streamline its complex clinical documentation processes.
With the help of Microsoft and two Microsoft Partner Network members, it implemented a Structured Content Management platform that is built on a foundation of Microsoft solutions, including the Intelligent Content Framework for regulated industries. The company’s
proof of concept addressed one part of the documentation compendium, the creation of patient narratives, which summarize patient results in a clinical study—saving the company 22,000 hours of work on 4,000 documents. Sanofi also benefits from easy-to-use,
industry-leading tools that generate high-quality and consistent messaging. The cost savings has already reached US$2 million.
With 110,000 employees in more than 100 countries, Sanofi manufactures and markets prescription drugs, vaccines, animal health treatments, and over-the-counter products. The company is a leader in areas including oncology, diabetes, thrombotic and cardiovascular
diseases, and rare genetic illnesses, and in manufacturing devices that are used to administer medications. The company’s net sales in 2012 were €35 million (US$45.7 million). “Sanofi as a corporation is very much focused on innovation and serving patients,”
says Joan Affleck, Global Head of Medical Writing at Sanofi. “These two factors make us a world leader in the production of new therapeutic solutions.”
Sanofi works closely with health regulatory authorities to make sure that drugs are safe and marketed appropriately. Like other organizations in the prescription drug industry, the company works hard to bring products to market in a timely fashion so it
can realize the greatest benefit from its patents.
For example, in the United States, the lifespan of a pharmaceutical patent is 20 years from the date that the company files the patent. Because it needs to conduct clinical trials to prove the product’s safety and efficacy, it can be several more years before
the pharmaceutical company submits a New Drug Application (NDA), the vehicle through which drug sponsors formally propose that the U.S. Food and Drug Administration (FDA) review and approve a new pharmaceutical for sale and marketing.
“When we file the patent application, the clock starts ticking,” says Affleck. “To actually get the drug to market is another hurdle.”
||Our collaboration with Microsoft and its partners enabled us to put ideas into action. This is a huge achievement for a pharmaceutical company. We managed change in a way that bridged ambiguity.
| Bhanu Bahl
Senior Manager of Clinical Sciences and Operation Platform, Sanofi
Throughout a product development cycle—and while the patent clock is ticking—the company is required to prepare, review, approve, and publish information in a variety of formats to satisfy the requirements of multiple regulatory agencies, public databases,
and external partners. Says Affleck, “In the pharmaceutical industry, we produce drugs and we produce documents.”
Pharmaceutical companies also experience “patent cliffs,” a sharp drop in revenues upon the patent expiration of one or more of their products. “It’s really important for us to continue delivering new solutions for patients while we recover from a patent
cliff,” says Affleck. “One of the ways that we can cut operating costs and capture market share more quickly than our competitors is by getting our document submissions to health authorities around the world rapidly—with the kind of quality that those agencies
Consistency in Clinical Documentation
Sanofi produces a wide variety of clinical documents. Delays in the clinical documentation process have the potential to postpone drug approval and make the entire process more costly, and the company stands to lose in the revenue sales cycle. Sanofi
also has an obligation to its patients who are sometimes waiting for drugs to be approved. “We have an ethical responsibility to provide patients with options as quickly as we can,” says Affleck.
To address these business concerns, Sanofi evaluated its clinical documentation capabilities and identified numerous gaps. The document creation process was complex, costly, and time consuming. The markup and navigation of documents was cumbersome. When
an employee modified source content, there was no automated means to notify stakeholders of the changes—changes that frequently impacted other documents. Reviews and approvals, which often required the participation of time-constrained executives, could take
months. Review cycles frequently involved approving the same information in multiple documents.
“We realized that if we implemented an optimized system for standardizing content across different outputs, we could be more efficient, increase document quality, and decrease costs,” says Affleck. “We wanted to align with healthcare industry standards in
producing clinical documentation and demonstrate our leadership in the application of standards in the pharmaceutical space.”
With any given product in development, Sanofi conducts multiple studies in a variety of settings to prove indications. For example, a product might be indicated for headaches. When these different study groups generate documents that vary in style and messaging,
regulatory agencies may consider the information to be inconsistent. “Our goal was to get all of these groups to produce consistent documentation,” says Mitzi Allred, Clinical Domain Program Leader at Sanofi. “If a health authority detected inconsistencies,
there could certainly be questions about the project’s design and execution. We want to be known as a company that delivers consistent messages.”
For Sanofi, it’s also critical to provide physicians and patients who participate in clinical studies with consistent and concise messages. “We have to protect the safety of patients every step of the way,” says Allred. “We wanted to make documentation more
coherent so all stakeholders can understand how the studies are constructed together.”
Complexity in Document Production
While Sanofi stored—and continues to store—clinical information in paper-format analog documents such as PDFs, it still needed to be able to manipulate content and make data available for search. In many cases, the company is also obliged to deliver
documents to regulatory agencies in specific electronic formats, and agencies test documents to ensure they are “e-filing compliant.” “If a document fails a regulatory agency’s test, it is returned to us to be reworked,” says Allred.
For example, patient narratives are summaries that describe specific safety events for individual patients in a clinical study, and must be submitted to regulatory authorities within a particular timeframe and by using a particular format. “Each patient
narrative aggregates patient data from at least three different data sources, and the process to write, review, and publish the summaries was incredibly time-intensive and expensive,” says Affleck. “If a study required 4,000 patient narratives, for example,
the total time required to produce them quickly added up to several years of work—for a single study.”
The company sought standard methodologies and enabling technologies for content collection and aggregation. It wanted an efficient process and automated tools for generating and delivering clinical documentation. “We had a lofty goal,” says Affleck. “We
wanted to be able to say to reviewers, ‘You’ve already approved Part A, but please take a look at Part B, which hasn’t been approved yet.’”
In January 2011, Sanofi launched a program called CRUISE—Content Re-Use Information System for Electronic Health. Through CRUISE, the company set out to develop a content management solution that transverses the company’s research and development efforts.
The program charter of CRUISE is to implement processes and tools that enable stakeholders to author, assemble, review, approve, reuse, publish, and deliver high-quality, consistent, and compliant content and documentation throughout the product development
life cycle—aiding the submission to regulatory agencies and other industry audiences. “The idea is to find ways to intelligently and seamlessly manage content authoring and production,” says Bhanu Bahl, Senior Manager of Clinical Sciences and Operation Platform
at Sanofi. “The key business objective is to reduce the effort required to prepare documents through a synergy of optimized processes and enabling technologies.”
||It’s been incredibly invigorating to work with partners who share a vision about the way we can employ transformational innovations that improve deliverables in our industry.
| Joan Affleck
Global Head of Medical Writing, Sanofi
CRUISE has three pillars. One pillar involves simplifying the documentation process in a way that makes it possible to reuse content in various materials. Another pillar revolves around services that involve the many different documentation deliverables. The
third pillar focuses on the technology solution, which is designed as a content library that tags and classifies information so that it can be easily assembled and searched. “With CRUISE, we are not doing a process redesign,” says Bahl. “We’re building something
more tangible, more simplified, and more standardized.”
To address the CRUISE mandate, Sanofi worked closely with Microsoft as well as two members of the Microsoft Partner Network, DITA Exchange and the ArborSys Group. Microsoft provided the Intelligent Content Framework (ICF) and underlying technologies based
on Microsoft SharePoint Server and Microsoft Office. DITA Exchange delivered a solution that enables organizations to establish and maintain a “single source of truth” for their strategic content, and to deliver that content consistently across outputs. The
ArborSys Group consulted on the tool and process redesign and helped achieve an end-to-end business and technology implementation for regulated industries.
Deployment of the Structured Content Management Platform
Sanofi deployed a Structured Content Management (SCM) platform—the technology pillar of CRUISE—called the Enterprise Content Optimization and Reuse Engine (EnCORE). The EnCORE tool uses Microsoft ICF technology and is built on the platform of Microsoft
SharePoint Server 2010. It employs SharePoint work flows, life cycle management, and search functionality.
By using the SharePoint platform and DITA Exchange solution that enables consistent content reuse and single source publishing, Sanofi can automate the assembly of data and accelerate the writing and reviewing of clinical documents. The solution also employs
a Microsoft Word plug-in that facilitates creating and editing topics. EnCORE accommodates a Structured Content Management (SCM) process that streamlines documentation processes for multiple departments and areas of expertise.
“We’re building a structured reusable topic library and content management facility for altering and assembling information in an accelerated fashion,” says Affleck. “The idea is to get to the point where each document features consistent information and
is in the voice of Sanofi—as opposed to being in the voice of multiple writers.”
The term “DITA” refers to Darwin Information Typing Architecture, the XML-based information model standard for content reuse and publishing that served as a foundation for the EnCORE solution. The DITA Exchange content management solution provides the following
Topic-based content authoring. Information is created in standalone modules that are reusable in many contexts and encourage clear and concise writing.
SCM functionality. Topics can be classified, marked up, and tagged with metadata according to product, audience, and other variables—and it can be reused in multiple publications.
Automated publishing. Documents can be easily profiled and published in the required formats to various output formats.
Sanofi employed native capabilities in SharePoint Server to create SCM workflows and design metadata models. “The solution did not require much coding,” says Allred. “We were surprised that we could so easily innovate by using out-of-the-box SharePoint features,
and we are using the tool in an integrated fashion to deliver a solution that’s on the forefront of technology.”
||SharePoint is now a mission-critical tool in the pharmaceutical space. By using Microsoft technologies as a foundation, we can achieve a great deal of innovation while maintaining a great user experience.
| Ole Rom Andersen
CEO, DITA Exchange
In January 2012, Sanofi began working on its first CRUISE proof of concept. The company chose to rework the production of patient narratives. “We started with patient narratives because it was a deliverable that didn’t have an established process or technology
in place,” says Bahl. “It was an achievable goal and a holistic place for CRUISE to start because it gave us the opportunity to bring all three forces—service, process, and technology—into play.”
The company deployed EnCORE and delivered its first set of patient narratives from one clinical study in June 2012. Sanofi was successful in streamlining the process of writing, reviewing, and publishing the summaries. By October 2012, it had used the platform
to deliver narratives to two regulatory agencies for 26 additional clinical studies. “We were fabulously successful with the patient narrative exercise,” says Affleck. “From a business perspective, we were able to prove the time, resource, and cost savings
that we could obtain by using a consistent and standardized content reuse platform for our information.”
Next Steps for Implementing CRUISE
The CRUISE program is currently focused on ensuring that documents conform to the Study Data Tabulation Model (SDTM) as defined by the Clinical Data Interchange Standards Consortium, a nonprofit organization with a mission to develop global data standards
for healthcare information. SDTM provides a standard structure for clinical trial data that is submitted as part of a product application to a regulatory authority. “To date, we have a near finalized, standardized SDTM process for patient narratives,” says
Bahl. “And we will continue to improve processes, one clinical study at a time, so that we can drive maximum value across the whole range of documentation deliverables.”
Several clinical study deliverable areas are on the docket for EnCORE deployment. For example, Sanofi has already begun reworking the protocol service, a set of reference documents used in defining data collection methods and determining how to treat and
evaluate trial subjects. “We are redesigning documents across the board,” says Allred. “Several services are in progress.”
Ultimately, the company will employ the SCM model in the labeling arena as well. In the pharmaceutical industry, labeling indicates the patient information that is included with every product in the marketplace. The label is the contract with health authorities
that enables companies to market a drug under specific conditions. Though the label is concise, it’s the final output of many thousands of documents. “Because of the deep and mutually beneficial partnership we have with Sanofi, DITA Exchange will be developing
a new and distinct global labeling solution,” says Ole Rom Andersen, CEO of DITA Exchange. “It will be a SharePoint-based solution that is not available anywhere else in the world.”
In June 2012, Microsoft honored Sanofi with the Microsoft Life Sciences Innovation Award because the company had used Microsoft technologies to dramatically streamline its documentation processes and increase overall efficiency. “I am fortunate to have led
the CRUISE program effort that resulted in Sanofi receiving the Microsoft Life Sciences Innovation Award,” says Bahl. “The implementation of this trail-blazing Structured Content Management solution for clinical documentation is path-defining at Sanofi and
establishes the company’s leadership in the pharmaceutical space.”
The Intelligent Content Framework Partnership
It was in 2010 when Sanofi began imagining the capabilities for CRUISE and submitting RFIs [requests for information] to collect information about various suppliers. “Our requirements were very detailed,” says Bahl. “Very few industry partners were
prepared to tackle these challenges holistically.”
||The technological advances and thought processes that have gone into the CRUISE program have been breathtakingly beautiful.
| Mitzi Allred
Clinical Domain Program Leader, Sanofi
Gabor Fari, Director of Life Sciences Solutions at Microsoft, served as an evangelist in helping to put together the CRUISE team. DITA Exchange had been working closely with Microsoft since 2008 to develop the ICF for regulated industries. It completed the
first version of the XML-based solution in February 2009.
As the technology pillar of CRUISE and the engine of EnCORE, DITA Exchange software elevates SharePoint to an XML-based component content management and single-source publishing solution. It enables its customers to comply with regulatory requirements with
tools for reusing content in a consistent and accurate way throughout the product development life cycle in the life sciences space. “Microsoft promoted our work to several pharmaceutical companies,” says Andersen. “It led the way in terms of bringing innovative
ideas around SCM solutions.”
DITA Exchange began working on the CRUISE implementation in April 2011. The partner participated in planning and supplied the solution used to manage the document output maps, topics, and linking of topics to the maps. “DITA Exchange helped us with content
design and the governance structures of information design,” says Allred. “The people at DITA Exchange are masters of their technological domain. They have experience in regulated industries and the knowledge required to get our vision into an operational
The ArborSys Group joined the effort in April 2011. This partner provides business consultancy and technical implementation and helped Sanofi achieve measurable and sustainable results through the implementation of flexible IT solutions that can be adapted
for change in a dynamic business climate.
The two partners collaborated on developing the EnCORE platform. The ArborSys Group scoped processes, integrated service management roles and extensions, and trained internal resources.
“Microsoft, DITA Exchange, and the ArborSys Group all provided expertise and leadership in terms of how we define processes and address the three pillars of CRUISE,” says Bahl. “The various disciplines they provided really helped us strategize our best opportunity
in terms of development. We share a common vision that has resulted in a very rich, cutting-edge offering that other pharmaceutical companies will probably adopt three to five years from now.”
While many other regulated industries have embraced SCM in recent years, life science organizations have lagged. “It’s no secret that the pharmaceutical industry is conservative,” says Andersen. “People think very carefully before they start anything. Sanofi
is absolutely the leader in innovating in the pharmaceutical content management space.”
By working in partnership with industry thought leaders, Sanofi benefits from industry-leading technology and processes that have the potential to revolutionize the way that life sciences organizations manage content and publishing. The company is positioned
to produce high-quality documentation across the product life cycle in ways that reduce time-to-market, promote consistency, increase revenues, and reduce costs. “Our collaboration with Microsoft and its partners enabled us to put ideas into action,” says
Bahl. “This is a huge achievement for a pharmaceutical company. We managed change in a way that bridged ambiguity.”
Innovates Documentation Processes
||EnCORE is a very elegant way to ensure compliance. It’s a goldmine of innovation and a model for what can be done in this conservative, regulated industry.
| Joan Affleck
Global Head of Clinical Documentation, Sanofi
The CRUISE program offers Sanofi new opportunities in every aspect of producing clinical documentation, from the tools to the processes. “EnCORE is a very elegant way to ensure compliance,” says Affleck. “It’s a goldmine of innovation and a model for
what can be done in this conservative, regulated industry.”
While Sanofi took a chance in tackling the document management process, its collaboration with Microsoft, DITA Exchange, and the ArborSys Group has resulted in a sophisticated yet simple-to-use solution that changes the landscape for the pharmaceutical industry.
“The technological advances and thought processes that have gone into the CRUISE program have been breathtakingly beautiful,” says Allred.
The four parties involved in CRUISE implantation are developing content management processes and tools that will help determine pharmaceutical industry best practices. “It’s been incredibly invigorating to work with partners who share a vision about the
way we can employ transformational innovations that improve deliverables in our industry,” says Affleck. “It’s so heartening to see what I imagined materialize right before my eyes.”
The success of the CRUISE program is testimony to how Microsoft and its partners can build a deep business relationship with its customers to solve industry-wide business problems. “The Intelligent Content Framework is a vision and technology approach that
has been developed over many years of observing how life sciences companies struggle with managing content—and their need to have a single version of the truth,” says Fari. “It is exceedingly gratifying to see this vision come to life for one of our most important
global life sciences customers.”
By using the Microsoft ICF approach and out-of-the-box features of SharePoint Server, the company is spearheading thought leadership in terms of how documentation is managed during the drug development process. “I think it’s obvious that big pharmaceutical
companies listen very carefully to Microsoft for governance and advice,” says Andersen. “SharePoint is now a mission-critical tool in the pharmaceutical space. With Microsoft technologies as a foundation, we can achieve a great deal of innovation while maintaining
a great user experience.”
A widely used rule of thumb in the pharmaceutical industry says that the revenue from an average drug is around $1 million per day. With the old manual approach, the only way to manage clinical documentation involved redundant review processes that
required the time-intensive participation of executives. With EnCORE in place, Sanofi can reuse information, review content, and deliver high-quality documents in a streamlined way that makes it possible to bring pharmaceutical products to market much faster.
“The ability to adopt a metadata-driven approach to content management is a paradigm shift that accelerates content production and improves accuracy,” says Fabien Jolly, Vice President of Technology and Information Management at Sanofi. “Reusing content
will deliver significant productivity gains across the organization and reduce regulatory risk. Over time, this capability will add value across the company.”
||The ability to adopt a metadata-driven approach to content management is a paradigm shift that accelerates content production and improves accuracy.
| Fabien Jolly
Vice President of Technology and Information Management, Sanofi
The company has realized a time savings of 70 percent to 80 percent in producing patient narratives. It anticipates a time savings of between 15 percent and 30 percent for other deliverables. “Reviewers can easily approve only the information that they haven’t
yet reviewed,” says Affleck. “This aspect alone is saving a great deal of time.”
The company has been able to reuse 65 percent of its patient narrative content. “If you get 65 percent reuse of content for a particular document type, that means that the writing time is reduced by 65 percent,” says Bahl. “Sanofi also saves time because
stakeholders have the most updated version of the content very early in the product development life cycle. Having that information populated so early is a big service for the business.”
Sanofi expects that for a study generating 4,000 clinical documents, the SCM approach will reduce the effort from 24,000 hours of work (6 hours per document) to just 2,000 hours of work (30 minutes per document)—a more than 80 percent time reduction. “It
is a work in progress to iteratively realize savings and deliver on our goal of providing business value,” says Bahl. “It took a lot of discipline and agility to create tools and services that users can run with.”
Improves Document Consistency
Sanofi has delivered easy-to-use tools and processes, which has been very helpful from a change management perspective. “The applications are simple and straightforward,” says Affleck. “The environment features a Microsoft Office-based interface that
is very familiar to users, which is essential when training employees.”
The company has also realized its goal of producing the highest quality documents possible to distribute to health authorities and partners. Because many studies take place over multiple years, consistency over time is key to improving document quality.
“With this solution, we are producing documents in the voice of Sanofi,” says Affleck. “Related documents contain the exact same information.”
With the highly adaptable and accountable EnCORE approach, Sanofi can take advantage of efficient and reusable SCM processes while proactively ensuring compliance with health authorities. “We’ve reduced the effort required to prepare, compile, and analyze
documents through a synergy of optimized processes and enabling technology,” says Michael Robbins, Assistant Director of Technology and Information Management at Sanofi. “With this kind of structured authoring, we are leading the way to generating consistent
clinical documents and transforming our enterprise.”
CRUISE program stakeholders believe the patient narratives exercise was a great opportunity to integrate the many different pieces of EnCORE. “We created a little bit of a star,” says Allred. “We intend to bring the same value to the whole product development
compendium. That’s where we’re going to really see the consistency, quality, and longevity that we’re striving for. We’re making great progress toward that goal.”
Generates Significant Costs Savings
For Sanofi, the return on investment can be measured by time and cost savings and faster time-to-market, and both factors result in increased revenues. For the patient narrative stage of the EnCORE implementation, Sanofi estimates that the company
can realize a cost savings potential of $275,000 for 1,000 narratives and $2 million for 7,500 narratives.
“We’ve been following the process consistently and measuring performance,” says Bahl. “The initial patient narrative results include the time it took to implement the technology plus the time required to get documents published. We realized savings of more
than $1 million in just one study.”
When it started the CRUISE program, Sanofi knew it could stretch the content management solution to other departments in the company. Says Affleck, “When we move completely beyond the traditional solution to full implementation, the savings will make everyone
Microsoft Solutions for the Healthcare Industry
Healthcare and life sciences organizations are under tremendous pressure to meet regulatory requirements, improve patient care, and reduce the time it takes to develop drugs and take them to market. To meet this challenge, Microsoft and its partners have developed
cost-effective solutions that enable healthcare organizations to streamline and automate daily processes that improve productivity and deliver information whenever and wherever it is needed. The result is enhanced productivity, safety, and quality.
For more information about Microsoft solutions for the healthcare industry, go to:
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