Position Paper on Value of Technical Publications in the Pharmaceutical Industry

1. Position Paper on
Value of Technical Publications in
the Pharmaceutical Industry

3. Introduction
This paper presents the value and need for TWB - Leading Technical Documentation
high-quality Technical Publications in the multi-billion
pharmaceutical industry to support its bid for not only Outsourcing Company
recouping the financial invest but also contributing to
healthcare.
TWB is a leading technical communication
outsourcing company that provides services in
Technical publications created in the pharmaceutical
technical documentation.
industry range from protocols for clinical trials and
regulatory documents for drug submissions to
Research and Development (R&D) process TWB is the ideal choice for leading pharmaceutical
documentation and patent documents. In addition to companies that require critical documentation of long
these documents, pharmaceutical documentation labyrinth of drug discovery and development process
includes medical journals, research analysis reports, (about 8-10 years) for timely submissions to
and pharmaceutical promotional materials. regulatory bodies – it has expertise in the
documentation for the Investigational New Drug (IND)
submission, the voluminous New Drug Application
Characterized by risky R&D process, intense
(NDA), patent management, and post release
competition for Intellectual Property, strict
performance reports and quality records to regulatory
governmental regulatory process, and purchaser
bodies.
pressure, the highly complex pharmaceutical industry
structure relies heavily on documentation to compile
the voluminous body of information during the TWB also handles meticulous documentation of R&D
lifecycle of a drug. The industry also needs processes of various facilities of the same company.
successful medical journals and business collaterals This enables effective knowledge transfer and
for promotional purposes. knowledge control between these facilities, which is
crucial to the fast-track production process of a drug.
Medical journals and business collaterals are other
The markets trends hold a robust and promising
areas of expertise, besides creating corporate
future for the pharmaceutical industry, with the
presentations.
pharmaceutical market expected to touch $1.3 trillion
mark by 2010. This expected market surge will bring
about a fierce competition among the industry TWB works closely with client teams located globally,
leaders, leading to increased R&D. This will inevitably and assists them in meeting their worldwide product
result in newer products, both patent protected and announcements and launch deadlines. TWB’s
generics. documentation services enable customers launch
their products with world-class documentation.
Every drug goes through a highly complex preclinical,
clinical, and post clinical phases of R&D process. In “Knowledge is people, money, learning, flexibility
this process, careful, comprehensive, and effective and competitive advantage. Knowledge is more
documentation is a perforce requisite for the timely relevant to sustained business than capital or
submissions of regulatory documents. Moreover, post labor. And yet knowledge remains the most
approval, publication documents like medical journals neglected asset of a business. TWB helps you
and promotional materials determine the successful unlock and share your technical knowledge with
market performance of a drug. the world.”
With pharmaceutical market conditions remaining
evergreen and with more of baseline works like
literature search for corporate presentations, data
management, and IT being outsourced, the industry
today requires a highly effective documentation
process in place.
“TWB believes that the technology cannot exist
without being communicated effectively.”
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4. Pharmaceutical Industry – Technical Publications
Being one of the largest knowledge-driven industries,
Challenges and Solutions
the pharmaceutical industry includes establishments
engaged in constant R&D and manufacturing of
medicines for the treatment and cure of various
diseases and conditions in human beings and Some of the greatest documentation challenges
animals. This industry consists of production and that most pharmaceutical companies face today
marketing of branded drugs, generics, non- include:
prescription or over-the-counter medications, and
related medical devices and technologies.  Timely submissions of documents to regulatory
bodies
The industry continues to witness a constant growth,  Accuracy and quality of documents submitted
despite the recent economic slowdown. According to  Documentation of voluminous information in a
IMS, pharmaceutical sales experienced a staggering frighteningly quick turnaround time
growth of 4.8% in 2008, compared to 6.6% in 2007.  Quick and quality review process
This growth rate was predicted to decline during
 Integration and management of documents
2009, with only 2.5% to 3.5% growth expected.
 Cost cutting in a multi-vendor business
environment
Pharmaceutical Market Growth (2001-2008)

TWB’s long-standing, impeccable record in
1000 handling medical documentation, coupled with its
773
800 715 large pool of the industry expertise and experts,
(US$ in Billions)
605 648
World Market
499 560 provides the following solutions:
600 429
393
400
200  Cost-effective knowledge documentation and
0 knowledge management
2001 2002 2003 2004 2005 2006 2007 2008  Integrated documentation process
Years
 Simplified, multi-staged documentation and
review processes
However, the future of the pharmaceutical industry is  Virtualization of work space enabling fast track
not bleak. According to a market analysis, the
reviews
pharmaceutical markets will more than double with
 Goal-driven approach to ensure quality and
figures touching $1.3 trillion in sales by 2020. This
growth is predicted to be the result of R&D and accuracy
business model revamp that will be brought about by
the decreased dependence of blockbuster drugs
(many of them are going off patent), bifurcation,
Benefits
value-added innovation, prevention-based products,
new R&D technology, global regulatory process, A leading pharmaceutical company, because of its
made-to-order production model, and emerging association with TWB, has drawn the following
markets. benefits:
Knowledge management and knowledge transfer are  Significant dollar saving, because of the quick
going to be critical to the quick release of a product in turnaround time
the market and its market performance, in this  Significant hour saving, allowing increased
forecast market scenario. The way a company productivity
manages and transfers its knowledge-base will shape
 High-quality, error-free documentation because
its position in the highly competitive industry.
of TWB’s unquestionable expertise in medical
writing, data and research management and its
“With the current operating environment, there multi-staged approach to work
has never been a greater need for information  Maximized usability of documentation due to the
on the activities of the global pharmaceutical quality of service rendered by TWB
industry.” – Centre for Medicine Research
This spending will further increase as the Indian
“With the current operating environment, there
Defence Industry is determined to for information
has never been a greater need increase the
participation of privatethe global pharmaceutical
on the activities of investors.
industry.” – Centre for Medicine Research
Presently more than 5,000 Indian companies are
The Writers Block25% of components and
supplying around www.twb.in 2
subassemblies to state-owned companies.

5. Value of Technical Publications
Technical Communication for Publications for Different Levels of
Transferring Product Knowledge Technical and Product Knowledge
ra
The purpose of technical communication is to transfer In the pharmaceutical industry, the users of the
product knowledge to end users in a comprehensible documentation vary from regulatory bodies to
manner. The strategies of communication and levels physicians and caretakers to patients who use
of information vary depending on the type of product prescribed drugs. If users have extensive
and audience. pharmaceutical knowledge, then they just need to
learn about the specifications and benefits of using
the product.
Providing end users with information about a
product’s operation and maintenance is critical to the
market performance of the product. Hence, the need For example, a regulatory body needs to learn
for quality documentation is imperative. about the chemical specifications of a drug and the
process involved in developing the drug, to
evaluate if the drug has the clinical effect claimed
In today’s business scenario, technical publications
and it does not have unacceptable side effects.
are often developed as an afterthought. This usually
results in inaccurate and incomprehensible
documentation, which, in turn, renders the users For users who start without scientific or product
incapable of using the products. knowledge (for example, a physician or a nurse), it
is important to provide instructions on how to use a
product or administer a drug, apart from the
Accurate, readily understandable, and quality
product knowledge.
documents determine how a product sells in the
market and result in increased customer satisfaction.
Attractive Publications as Useful
Faulty Assumptions that Result in Marketing Tools
Problems in Documentation
Besides transferring knowledge, technical
The faulty assumptions listed below result in publications are also used for marketing a product.
incomprehensible documents: Before a product is released in the market,
information about the product needs to be
 Developers know their products better than effectively communicated to the customers.
anyone else – due to time constraints and limited
resources, many companies assign their Well-designed, accurately presented, and attractive
documentation tasks to the programmers. This marketing collaterals increase the market prospects
more often results in the creation of technology- of a product and reduce support costs.
centered information, while end users require
task-oriented information.
 Documentation of complex applications requires a
longer learning curve for the writer - learning the
product will not be a major obstacle for writers
with the right technical background.
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6. Conclusion
 Price Competitive Growth in the Pharmaceutical Industry: Growth of companies in the pharmaceutical
industry relies heavily on the accurate, timely, and cost-effective documentation process. The pharmaceutical
companies portray a global presence and need technical publications that can be used in different
geographies. Besides scientific documents to be submitted, marketing these products require supportive
business collaterals and product documentation for global audience.
 Value of Technical Publications: Technical Publications are very essential for transferring product
knowledge to the end users. Provisioning of proper material to use the technology and products enables the
user to accept and efficiently use the product. Faulty assumptions about documentation lead to inaccurate
and hard-to-understand material. This also decreases the chances of marketing the products in the global
markets.
 Role of Documentation Outsourcing: The enormity and complexity involved in medical documentation
requires that pharmaceutical companies consider outsourcing their documentation needs to well-established
Technical Publications Solution providers. This helps the companies cut costs and at the same time deliver
their products with quality documents.
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7. TWB Services
TWB is India’s leader in technical communication outsourcing and education. TWB offers a complete suite of services that allow
our customers to effectively publish their technical knowledge with their people and processes. TWB’s customers range from
Global 500 – including Cisco, Accenture, McAfee, LG, Samsung, Citrix, SAP, Siemens, AOL, Intel; Indian technology majors –
including Infosys, Wipro; Global defense majors - Pratt & Whitney, Honeywell, DRDO, HAL; and exciting technology startups.
TWB's expertise in technical communication ranges from IT Products and Outsourcing, ITES, Banking, Financial, Aerospace,
Defense, Ship Building to Hi-tech Manufacturing, and Discrete and Process Manufacturing.
TWB’s services include:
Technical Marketing Technical Product Documentation Quality
Solutions Documentation Management
 Datasheets
 Administrator’s Guide
 Datasheets  Copy Editing and Proof Reading
 API Document
 Cheat sheets  Managing Writing
 Configuration Guide
 Solution Briefs/Solution Brochures  Editing Services
 Functional Specifications Document
 Presentations –  Layout and Design
Products/Corporate Profile  Installation Manual
 Creating SLAs
 Brochures and marketing collateral  Interface Document
 Web content  Interactive Electronic Technical Business Documentation
Manual (IETM)
 Audio and video scripts
 Maintenance Manual  Business Proposals
 Press releases
 Online Help  Legal Disclaimers
 Direct mail
 Operation Manual  Policy Manuals
 Newsletter design copy
 Product Demo  Style Guide Design
 Sales catalogues
 Product Specifications Document  Template Design
 Sales sheets
 Product Overview Document
 Quick Reference Guide
Business Communication Content Management
 Release Notes
 Short Reports  Requirement Analysis Document
 Single Sourcing
 Proposals  SDK Document
 File Version Control
 Case Studies  Troubleshooting Manual
 Document Naming Conventions
 Lab Reports  User Manual
 Consistent Document Formatting
 Memos  Open Source Documentation
 Data Transformation
 Progress/Interim Reports  Programmers Guides
 Writing for Electronic Media  Functional Specifications Document
 Use Cases Web site Development
Illustrations  Online Help /Context Sensitive Help
 Web 2.0 development
 Troubleshooting Guides
 Graphic Designing  Web content

 Info graphics  Web applications
Qualitative Analytics for
 2D & 3D animation
Decision Support Translation and Localization
 Line drawings and illustrations
Services
 Economic Business Research
Process Documentation
 Industry Analysis  Software Translation Services
 Workflows  Market Opportunity Analysis  Document Translation Services
 Standard Operating Procedures  Competitive Business Analysis  Localization (L10N) Testing
 ISO Documentation  Company & Prospect Profiling  Internationalization (I18N) Testing
 CMM Documentation  Reporting Solutions
 Assessment of Unmet Market Needs Records Management
Deployment and Support  Status and Potential of Technologies
 Document Management Solutions
 Benchmarking of Strategies Vs
 Record Management Storage and
 Installation and Configuration Competition
Retrieval
Guides  Forecasting
 Operations Manual  Sales Force Effectiveness
 Market Assessments
 Competitive Intelligence
 Opinion Leadership
 Emerging Markets - evaluation and
research
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8. TWB Software Tools Expertise
Our technical proficiency in software and authoring tools includes:
Unstructured Content XML Structured Editors Multimedia/Authoring
Development
 Epic  Adobe Flash®
 Microsoft Word®  FrameMaker+SGML  Adobe Dreamweaver®
 Adobe FrameMaker®  X-Metal®  Microsoft FrontPage®
 Adobe InDesign®  Adobe Captivate®
 QuarkXPress® Macromedia Captivate
 Adobe PageMaker® Graphics/Animations
 Multimedia/Authoring/
Illustrations  Adobe Flash® Supporting tools
 Adobe Photoshop®
 Adobe Flash CS4 Professional  Adobe Fireworks®  Adobe Flash®
 Adobe Illustrator CS3  Adobe Flex®
 CorelDRAW Online Help  Adobe AIR®
 Microsoft-Expression Graphic  Adobe Dreamweaver®
Designer  Adobe Acrobat®
 Xara Xtreme (Windows & Linux)  JavaHelp
 Microsoft Silverlight®
 CuteDraw  Adobe RoboHelp 7.0
 Adobe Authorware®
 Publisher3D(for animation)  HelpScribble
 Adobe Director®
 Sketsa SVG Editor (for vector  WebWorks Publisher
 Adobe Captivate®
graphics)  PowerCHM
 Trivantis Lectora®
 Techsmith Camtasia  Doc-To-Help
 ASP.NET
 Arbortext IsoDraw (technical  WinCHM
 JSP
illustrations for 2D and 3D)  HelpSmith 2.1.1(Windows)
 JAVA
 Fast-Help
 MadCap Flare Standards
Graphics/Animation  Help-Server
 NVU Help
 SCORM 1.2 / 2004
 Adobe Flash®  AICC
XML
 Adobe Photoshop®  W3C
 Adobe Illustrator®  Section 508
 Adobe Fireworks®  XMetal®  QTI XML
 Microsoft Silverlight®  Microsoft Word 2003®,
 Microsoft Word 2007®
Databases Development and Publishing
tools
CMS/LMS
 Microsoft Access  XSLT/XSL
 Microsoft SQL Server  EDD
 Sharepoint®
 Moodle
Flowcharting  Joomla,
 WordPress
 Microsoft Visio  Media Wiki
 iGrafx  CMS Builder
 EDraw  Author-it (formerly AuthorIT)
 RFFlow  Alfresco
 Flowbreeze
 Smart Draw
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9. Business
 Datasheets
Communic
 Administrat
ation Guide
or’s
 API
Industries Served
Document
 Configurati
on Guide
 Functional
Specificatio
ns
Document services a wide range of technology and knowledge driven industries, helping them meet their markets better, these include:
TWB
 Installation
Manual
 Banking, Insurance and Financial Services  ITES/ KPO/ BPO
 Interface
Document  Consulting and Business Services  Pharmaceuticals and Biotechnology
 Defense, Aerospace and Hi-Tech Manufacturing  Process Manufacturing and Allied Industries
 Interactive
Electronic  Education and Learning  Steel, Ship Building, Construction and Aviation
Technical  IT, ITES  Telecom and Digital Communications
Manual
(IETM)
 Maintenanc has been the preferred technical documentation outsourcing company for:
TWB
e Manual
 Online Help
 Operation
Manual
 Product
Demo
 Product
Specificatio
ns
Document
 Product
Overview
Document
 Quick
Reference
Guide
 Release
Notes
 Requireme
nt Analysis
Document
 SDK
Document
 Troublesho
oting
Manual
 User
Manual
 Open
Source
Documenta
tion
 Programme
rs Guides
 Functional The TWB Building US Office:
Specificatio No: 4062, 19th Main Road, TWB
ns
Document
HAL 2nd Stage, 11701 Norwegian Wood Drive
 Use Cases
Bangalore – 560008 Austin, TX 78758
 Online Help
India.
/Context Landmark: Behind Carlton Towers
Sensitive
Help
 Troublesho Telephone: Telephone:
oting +91.80.40741400 / +1.512.586.8357
Guides
+91.80.41256367
Corporate Enquiries:
corp@twb.in
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