industry solutions Documentum Solutions for Life Sciences Speeding Products to Market While Ensuring Compliance Meeting rigorous compliance requirements simply comes with the territory in the life sciences. So to prosper, companies must meet that obligation while constantly striving to shorten time to market. And the only way to achieve those dual, and often competing, goals is to manage information efficiently across the content value chain. uniting the world through content ™ 4: Manufacturing 5: Sales & Marketing 6: Customer Service Documentum — Up to the Challenge The content value chain describes how essential processes are related in an organi- zation and how content moves and is used across those processes. And in every area of the life sciences content value chain, Documentum helps reduce costs, ensure compliance, streamline production, enable collaboration, and get products to market faster. In fact, for every content management challenge a life sciences organization faces, Documentum provides a solution. And with our standards-based platform and world- class partner integrations, the opportuni- ties to leverage Documentum throughout your organization are virtually unlimited. Documentum can help you exploit the natural relationships between content and processes that start in discovery and extend all the way to customer service — which means your business becomes more agile, more responsive, and more competitive. On the following pages, we profile solutions that illustrate the varied ways in which Documentum is being used in every facet of the life sciences enterprise. SOLUTIONS > Knowledge Management and Collaboration > Alliance Partner Mgmt. > Electronic Laboratory Notebook > Lead Generation and Optimization > Competitive Intelligence SOLUTIONS > Knowledge Management and Collaboration > Alliance Partner Mgmt. > Electronic Laboratory Notebook > Regulatory Submissions and Compliance > Test, Methods, and Protocol Management SOLUTIONS > Knowledge Management and Collaboration > Alliance Partner Management > Contracts Management > Electronic Laboratory Notebook > Regulatory Submissions > Investigator Training and Communication > Regulatory Compliance SOLUTIONS > Knowledge Management and Collaboration > Quality Specification Mgmt. > SOP Management > Labeling and Packaging > Corrective/Preventative Action > Plant and Facility Mgmt. > Master Batch Records > Regulatory Compliance and GMP Content Management SOLUTIONS > Collaboration > Promotional Marketing Material Management > Medical Information Management with Integrated Call Center SOLUTIONS > Collaboration > Sales Force Enablement > Contract Management > Product Specific Web Sites > Disease Specific Web Sites 3: Clinical 2: Pre-Clinical The graphic above illustrates the ability of enterprise content management to integrate the content value chain across the primary functional areas of a life sciences organization. Highlights • Shortens time to market • Ensures compliance while reducing cost • Increases operational efficiency • Streamlines production • Enables secure, efficient collaboration 1: Discovery/Research
Transcript
industry solutions
Documentum Solutions for Life Sciences
Speeding Products to Market While Ensuring Compliance
Meeting rigorous compliance requirements simply comes with the territory
in the life sciences. So to prosper, companies must meet that obligation
while constantly striving to shorten time to market. And the only way to
achieve those dual, and often competing, goals is to manage information
efficiently across the content value chain.
uniting the world through content™
4: Manufacturing 5: Sales & Marketing 6: Customer Service
Documentum — Up to the ChallengeThe content value chain describes howessential processes are related in an organi-zation and how content moves and is usedacross those processes. And in every area of the life sciences content value chain,Documentum helps reduce costs, ensurecompliance, streamline production, enablecollaboration, and get products to market faster.
In fact, for every content management challenge a life sciences organization faces,Documentum provides a solution. And withour standards-based platform and world-
class partner integrations, the opportuni-ties to leverage Documentum throughoutyour organization are virtually unlimited.Documentum can help you exploit the natural relationships between content andprocesses that start in discovery and extendall the way to customer service — whichmeans your business becomes more agile,more responsive, and more competitive.
On the following pages, we profile solutionsthat illustrate the varied ways in whichDocumentum is being used in every facet of the life sciences enterprise.
SOLUTIONS
> Knowledge Management and Collaboration
> Alliance Partner Mgmt.
> Electronic Laboratory Notebook
> Lead Generation and Optimization
> Competitive Intelligence
SOLUTIONS
> Knowledge Management and Collaboration
> Alliance Partner Mgmt.
> Electronic Laboratory Notebook
> Regulatory Submissions and Compliance
> Test, Methods, and Protocol Management
SOLUTIONS
> Knowledge Management and Collaboration
> Alliance Partner Management
> Contracts Management
> Electronic Laboratory Notebook
> Regulatory Submissions
> Investigator Training and Communication
> Regulatory Compliance
SOLUTIONS
> Knowledge Management and Collaboration
> Quality Specification Mgmt.
> SOP Management
> Labeling and Packaging
> Corrective/Preventative Action
> Plant and Facility Mgmt.
> Master Batch Records
> Regulatory Compliance and GMP Content Management
SOLUTIONS
> Collaboration
> Promotional Marketing Material Management
> Medical Information Management with Integrated Call Center
SOLUTIONS
> Collaboration
> Sales Force Enablement
> Contract Management
> Product Specific Web Sites
> Disease Specific Web Sites
3: Clinical2: Pre-Clinical
The graphic above illustrates the ability ofenterprise content management to integrate thecontent value chain across the primary functionalareas of a life sciences organization.
Highlights
• Shortens time to market
• Ensures compliance while reducing cost
• Increases operational efficiency
• Streamlines production
• Enables secure, efficient collaboration
1: Discovery /Research
The longer it takes to approve a drug or medical device
for sale, the more of its patent lifetime is wasted. With
a blockbuster drug, you could be losing millions of
dollars per day.
Documentum has more experience providing solutions across the life sciences
content value chain than any other enterprise content management company. These
solutions demonstrate the breadth of expertise Documentum can bring to the business
ClinicalClinical Content ManagementInvestigator Training and CommunicationStudy/Protocol ManagementRegulatory Submission ManagementClinical Records ManagementCRO CollaborationCase Report Form ManagementSafety and Adverse Events ManagementCRO Contract ManagementSOP Management
ManufacturingSOP ManagementGMP Content ManagementBatch Records ManagementPlant and Facility ManagementLabel and Packaging ManagementCorrective/Preventative Action
ManagementTraining Records ManagementCMO CollaborationCMO Contract ManagementKnowledge Management
Sales & MarketingPromotional Material ManagementMedical Information ManagementSales Training Content ManagementDrug Safety ManagementCRM PortalsSales Force EnablementSOP Management
Customer ServiceProduct Specific Web SitesDisease Specific Web SitesPhysician PortalsProduct Complaint ManagementeDetailingWeb Site Management
Documentum Solutions for Life Sciences Organizations
Today, in life sciences, optimizing
the content value chain takes on a
unique dimension. Because there’s
more at stake than efficiency, profits,
or shareholder value. Life sciences
companies provide therapies that
bring hope to millions.
DOCUMENTUM SOLUTIONS
Challenge
Implement a Web-based, knowledge-sharing tool to help Boehringer Ingelheimcapture existing practices, work withteams to improve workflow, and imple-ment a uniform process that supportseffective collaboration between employeesand business partners. Effective collabo-ration, particularly with external partnerssuch as academics and other pharma-ceutical companies, is essential to keepingthe new drug pipeline full and speedingproducts to market. E-mail, fax, andtraditional mail were not adequate tosupport the high-volume informationexchange on which collaborationdepends, and they carried inherent security risks.
Solution
Boehringer Ingelheim found the eRoomdigital workplace to be ideal for its needs.Easy to learn and use, eRoom providesthe collaborative platform the companyrequired to rapidly assemble, support,and manage cross-organizational researchand discovery teams and respond to the dynamic nature of their work. Plus,eRoom requires no client software, whichis particularly important when bringingexternal partners online.
Results
At Boehringer Ingelheim, scientists,partners, project teams, support func-tions, and management use eRoom.Through its ability to capture organiza-tional learning over an extended periodof time, eRoom has enhanced BoehringerIngelheim’s decision making, researchprocesses, and work methods. The solu-tion has broken down departmental andgeographic boundaries and acceleratedthe free flow of information.
“Documentum eRoom enables us to fully embrace our partners in the pursuit of better, more effective, and innovative pharmaceutical products and services.”
Dan Greenwood, Associate Director Knowledge Management, Boehringer Ingelheim Pharmaceuticals
Documentum eRoom helps Boehringer Ingelheim
keep the new drug pipeline full and speed products
to market by enhancing collaboration with external
partners such as academics and other pharma-
ceutical companies.
The Boehringer Ingelheim group of
companies is a global pharmaceutical
enterprise that ranks among the top 20 in
the world. As thousands of pharmaceutical
candidates work their way through the
design and delivery pipeline, internal proj-
ect teams must work with a growing popu-
lation of geographically dispersed partners.
Drug discovery is where decisions are made that can affect the profitability of a company for years to come.
It’s where scientists and researchers try to distinguish between dead ends and lucrative opportunities. And where
knowledge sharing and collaboration are critical to determining which therapeutic areas and compounds
Deploy a collaboration tool that enablesaccurate version tracking of project doc-uments and the ability to aggregate allproject content in a secure, digital work area.
Solution
Aventis deployed Documentum eRoom to help control and streamline the collab-oration between chemists, biologists,toxicologists, and clinicians. Prior to the deployment of eRoom, collaborativework was done using e-mail. It wasimpossible to accurately track documentversions and maintain project documentsin a single secure area, accessible toeveryone. eRoom enables the capture of virtual team meeting results, reports, presentations, and test data. Documents,such as new drug feasibility studies,which require collaborative review andediting, can be tightly controlled andmanaged. All content is seamlesslyarchived in the Documentum repository.
Results
Documentum eRoom facilitates global collaboration in Drug Innovationand Approval (DI&A), where findingthe right information can prevent thenecessity of repeating pre-clinical trials or laboratory tests, which take weeks to administer. It allows new projects to move forward without repeating the mistakes of the past. In the future,Aventis plans to leverage tighter integration between eRoom and theDocumentum repository. This willallow more efficient project data miningacross eRooms, which will increase thevalue of collaborative knowledge even further.
Solution: Collaboration in Drug Innovation and Approval (DI&A)
Aventis
“Documentum eRoom facilitates global project team collaboration andspeeds access to the relevant information, enabling better decisions to bemade more effectively.”
Simon Marlow, Senior Director, Lead Generation, Drug Innovation and Approval, Aventis
Create a paperless system for storingthe knowledge contained in the hand-written notebooks of its research scien-tists. Make that information more easilyaccessible and retrievable, while ensur-ing its security.
Solution
Berlex deployed the Documentum ECMplatform in 1997. Soon after, the com-pany brought in Documentum Consultingto help develop and deploy an R&Dinformation management system thatwould also accommodate the creationand archiving of paper documents.
The Documentum system enabled Berlexscientists to use Microsoft Word andExcel to log their research, which wasstored on local servers and replicated to a central repository each night. Today,more than 800 scientists at facilitiesaround the world use the Documentumsolution, with more research facilitiesslated for deployment.
Results
Berlex can now leverage its intellectualproperty in ways that were impossiblewith a paper-based system. Researchthat is easily searched, retrieved, andshared retains its value far longer thaninformation archived in traditionalnotebooks. The initial investment thatproduced the research can be extendedto meet the demands of more projectsand revenue-producing initiatives.
“Our global R&D information management system, based on theDocumentum ECM platform, is on the cutting edge of electronic laboratorynotebook solutions. When we show people the old lab notebooks comparedto the quality of the information being captured by our scientists today,they are absolutely astonished.”
Charlie Sodano, Manager of Information Services, Berlex Laboratories
Berlex is committed to bringing to market
beneficial preventive, diagnostic, and
therapeutic medicines in the fields of
dermatology, diagnostic imaging, female
healthcare, therapeutics, and oncology.
The company currently owns a significant
share of the market for oral contraceptives.
As a research-based company, Berlex con-
siders intellectual property to be one
of its most important assets.
Pre-clinical trials screen drugs to ensure their safety for human testing. Safety and toxicity studies demonstrate
biocompatibility and identify safe dosage ranges for clinical trials. Leveraging existing research enables better
go/no-go decisions in this phase, which can significantly lower the cost of development by eliminating lengthy
clinical trials.
LIFE SCIENCES
Before Berlex deployed its
Documentum-based global
R&D information manage-
ment system, the company
relied on paper forms to
capture and store experi-
mental data.
With Documentum, Berlex created a flexi-
ble electronic notebook that used familiar
tools like Microsoft Word.
Challenge
Replace a paper-based system with anautomated system that enables clinicaltrial contracts to be created dynamicallywith custom attributes supplied by theauthors. Manage and archive the con-tracts in a central repository that isaccessible through a Web browser. Useworkflow to enforce compliance-basedbusiness rules through all stages ofreview and approval. Attach lifecycles to contracts to ensure they are retained as corporate records.
Solution
The company deployed a Documentumsolution that enables legacy contracts tobe scanned into a repository and indexedaccording to project number, investigatornumber, trial size, and project description.Contracts are stored as PDFs and can beannotated using Adobe Acrobat. Newcontracts are authored in Documentumusing a custom template and are auto-matically indexed as they enter the reposi-tory. Once a new contract template isopened, it initiates a workflow that routesthe document to each relevant party insequence. Alerts notify downstreamreviewers when a contract has beendelayed upstream more than 48 hours.
The system archives the contracts, aswell as their associated confidentialityforms, and is searchable by any attributeor annotation.
Results
This company generates thousands ofcontracts and hundreds of thousands ofpages of supporting documents annually.The Documentum contracts managementsolution enables the company’s legalgroup to efficiently create, manage, andstore this enormous volume while ensur-ing that all clinical trial contracts meetrelevant legal guidelines. When litigationarises, counsel can access contractualinformation quickly from any companylocation. Contract authoring, review,and approval require a fraction of thetime needed using the paper-based system, while an audit trail ensureswhich version of a contract governs a particular trial.
“Thanks to Documentum we can generate and manage our clinical trial contracts with a flexible, customized Web application. Considering theamount of legal documentation associated with clinical trials, that’s a significant productivity gain for us.”
Securely and efficiently control the flowof NDA-related content, enable accurateversioning, authorize and verify recipi-ents, and track changes involved forelectronic submission to, and compliancewith, regulatory agencies. Ensure thateach document in a submission is the correct document.
Solution
Allergan had used Documentum since 1996, but originally as a docu-ment repository only. To streamline the company’s NDA submissions processand ensure its accuracy and compliance,Allergan deployed a fully controlledenvironment based on Documentumworkflow and lifecycle management.The solution unites the company’s content value chain by controlling allupstream content such as discovery andpre-clinical data, ensuring that it hasbeen produced in a compliant manner.This content is integrated with clinicaltrials results and managed throughreview and approval to publishing andsubmission. Documentum enables elec-tronic submissions to the FDA, fullysupports 21 CFR Part 11, and produces a complete audit trail, effectively extend-ing the content value chain to includeregulatory agencies.
Results
A typical NDA submission is nearly onemillion pages, including summary andclinical study reports. Allergan’s abilityto compile and submit these applicationselectronically, and ensure that each oneof the pages is approved and accurate,means its NDAs have a much betterchance of being reviewed quickly, withoutdelays to correct faulty documentation.
Avoiding such delays is no trivial matter: the longer it takes to approve an NDA, the longer it takes to get a prod-uct on the shelves earning revenue. TheDocumentum solution at Allergan is usedworldwide, enabling pending submissionsto be reviewed simultaneously at sites inFrance, Japan, England, and the U.S.,further accelerating the process. ForAllergan, a faster, more accurate NDAsubmissions process translates to a sustainable competitive advantage.
Solution: Regulatory Submissions — Electronic Review and Approval
Allergan
“With Documentum, we can manage nearly 5 million pages of NDA documentation electronically, with increased speed, greater accuracy, and less cost. That means a new drug hits the shelf sooner and sells under patent longer.”
Jeff Kouba, Director, R&D Scientific Information Services, Allergan
“Our Documentum SOP management solution slashed the review andapproval process from 5 weeks to 3 days. That means QA, clinical, and validation processes aren’t interrupted waiting for an approved SOP.”
Jessica LeFur, Director, Document Management & Planning, OSI Pharmaceuticals
Challenge
Develop an electronic system for creatingand managing SOPs that would ensureaccess from any of OSI’s three locationsin New York, Colorado, and the UK.Reduce the cycle time for SOPs andensure the accuracy of SOPs across functional areas.
Solution
OSI deployed the Documentum SOPmanagement solution to gain stream-lined review and approval; faster, moreefficient access and distribution; andincreased accuracy, global consistency,and regulatory compliance. WithDocumentum, electronic review andapproval of a final SOP can take just 3 days — instead of 5 weeks using the old system. Once an SOP has beenapproved and certified with a digitalsignature, it cannot be changed withoutentering a formal workflow process.
Results
Streamlined SOP management means a reduction in the time and expense of rework. For example, if an SOP forclinical protocol writing is changed anddelayed in review, an in-process protocolmay have to be redone once the SOPhas been approved. Through acceleratedreview and approval and tight versioncontrol, Documentum ensures that thedistributed version of an SOP is the mostrecent and accurate. The Documentumrepository also enables authorized accessto all SOPs from any location.
“Documentum Web Publisher has enabled us to cut the cost of developingnew Web sites by two-thirds. And keeping Web content fresh and accurateis quick and easy, too.”
Stephen Taylor, Business Project Manager, AstraZeneca
Challenge
Eliminate the “Webmaster bottleneck”and reduce the time needed to publishcontent to the Web. Empower businesscontent owners to publish on their ownwhile ensuring content accuracy andmeeting compliance requirements. Reducethe cost of Web development to makeshort-term micro sites economicallyjustifiable.
Solution
Documentum Consulting and anAstraZeneca project team delivered an XML-based, Web development infra-structure for quickly and easily creatingWeb sites. Their solution featured ageneric set of XML templates, reusablelifecycles and workflows, defined busi-ness rules, updatable menus, and 24x7
support. Workflow automatically routesWeb content through proper approvalsin an auditable process, which increasescontent accuracy and diminishes legalliability. Now, publishing trusted contentto the Web can be done in a matter ofseconds, with no IT involvement required.
Results
Documentum dramatically reduced thecost of Web development from $75,000per site to $25,000. At the same time,publishing speed increased and accuracyimproved, while Webmasters were freedto focus on more value-added projects.
“We selected Documentum as our infrastructure for rich media assets andrelated content based on its market leadership, support for Mac environments,and strong base of existing life sciences customers. Documentum has workedwith us to realize new levels of operational efficiency.”
Craig A. Cuyar, PhD, Senior Vice President & Group Chief Information Officer, CommonHealth
Challenge
The clients of CommonHealth need todistribute materials globally, maintain aconsistent brand image, and reduce thecosts of product marketing. Yet fewhave invested in automating their collat-eral production process. CommonHealthfound that there were significant obsta-cles to efficient and cost-effective produc-tion, such as client/advertising agencyinteraction, last-minute changes, dissemi-nation and review of comps, media pro-duction and courier expense, and theinability to verify usage rights. The resultof all these factors, besides increased costand time to market, was the frequent useof unapproved brand collateral.
Solution
CommonHealth created and deployedSynthesis, a Documentum-based solutionthat offers clients a way to streamlinecollateral production and revolutionizethe agency/client business model. Phaseone of Synthesis automates the tradition-al process pharmaceutical brand teamsuse for creating, approving, and distrib-uting collateral. Subsequent phases willleverage additional Documentum func-tionality such as the eRoom collaborationplatform, job-based lifecycles, inter-enterprise workflow, and asset distribu-tion to other Documentum systems.
Using the Documentum ECM platform,Digital Asset Manager (DAM), andMedia Services, Synthesis utilizes work-flow to assure quality control for allelectronic releases, enables the prepara-tion of content to precise specifications,and electronically releases project files to vendors and clients.
Results
For two clients using Synthesis,CommonHealth sees potential ROI ofover 300 percent, with a payback of lessthan one year. Synthesis virtually elimi-nates the time and expense of producingmedia and shipping comps and at thesame time improves agency/client com-munication. It compresses the reviewcycle while accommodating up-to-the-minute revisions and making them available online. With centralized accessto marketing content, clients usingSynthesis are also able to improve theconsistency of brand presentation.
Recommended Product Suite• Documentum Content Server• Documentum Digital Asset Manager• Documentum Media Services• Documentum Desktop for Macintosh• Documentum eRoom Enterprise• Documentum Authoring
“Documentum makes our call center much more efficient at fulfillingresponses to customer inquiries. Plus, it enables that efficiency while giving agents increased flexibility in assembling custom packages that have a more personal feel.”
Andrea Kozak, Technical Project Manager for Regulated Systems, Takeda Pharmaceuticals North America
Challenge
The majority of calls that come in toTakeda’s customer service center requirea written response consisting of a coverletter and a variety of enclosures such asjournal articles, product literature, andpackage inserts. Between 1,200 to1,500 calls per month require a writtenresponse. Service agents needed to accessrelevant content through their Siebelcall center application in order to makefulfillment less labor intensive and timeconsuming. With Takeda’s call centerlocated in North Carolina and the headoffice in Illinois, maintaining informa-tion consistency was also difficult.
Solution
Takeda deployed an automated call center fulfillment system based onDocumentum. The Documentum reposi-tory stores cover letter templates as XMLcomponents, issue-specific customerresponses, and all supporting collateral,which is fully accessible to service agentsthrough the Documentum integrationwith Siebel. When a customer call initi-ates a new case in Siebel, it also launchesa “package wizard.” With the wizard, anagent can assemble and print a completecustomer response package that includesa custom cover letter. All package com-ponents have workflow and lifecycles
attached to ensure that only approved,accurate content is used. Response pack-ages are compiled using Documentumvirtual document management (VDM)technology. Each package rendition is stored as a PDF and automaticallylinked to its virtual document.
Results
With Documentum, information trans-fer between call center and home officeis immediate. Agents can fulfill packagesmore quickly and, using XML, delivercustomized packages with personalizedcover letters. VDM enables efficient content reuse, while workflow and life-cycle management make the entire ful-fillment process completely auditable.Documentum also stores all verbalresponses to customer inquiries. Takedaexpects the Documentum system to becrucial in handling increased call volumeduring product launches.
Documentum — The Solution of Choice for Life Sciences
The top 25 pharmaceutical companies in the world are Documentum customers and more than 200 life sciences companies employ Documentum solutions. To learnhow Documentum can deliver improved business performance to your life sciencesorganization, visit us online at www.documentum.com/industry/life_sciences or call 800.607.9546.
A Partial List of Documentum Customers in Life Sciences
Corporation, provides enterprise contentmanagement solutions that enable organizations to unite teams, content,and associated business processes.Documentum’s integrated set of content,compliance, and collaboration solutionssupport the way people work, from ini-tial discussion and planning throughdesign, production, marketing, sales,service, and corporate administration.With a single platform, Documentumenables people to collaboratively create,manage, deliver, and archive the contentthat drives business operations, from
documents and discussions to e-mail,Web pages, records, and rich media. TheDocumentum platform makes it possiblefor companies to distribute all of thiscontent in multiple languages, acrossinternal and external systems, applica-tions, and user communities. As a result,Documentum customers, which includethousands of the world’s most success-ful organizations, harness corporateknowledge, accelerate time to market,increase customer satisfaction, enhancesupply chain efficiencies, and reduce operating costs, improving their overallcompetitive advantage.
North AmericaAllerganSolvay S.A.Bayer AGSchering PloughSanofi-Synthelabo
LIFE SCIENCES
For more information about howDocumentum can turn manual,paper-based information systemsinto an integrated content valuechain, visit www.documentum.comor call 800.607.9546 (outside the U.S.: +1.925.600.6754).
