Twb position paper_pharmaceutical_industry


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Twb position paper_pharmaceutical_industry

  1. 1. Position Paper on Value of Technical Publications in the Pharmaceutical IndustryThe Writers Block 1
  2. 2. The Writers Block 2
  3. 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 Technical publications created in the pharmaceutical documentation. industry range from protocols for clinical trials and regulatory documents for drug submissions to Research and Development (R&D) process documentation and TWB is the ideal choice for leading pharmaceutical patent documents. In addition to these documents, companies that require critical documentation of long pharmaceutical documentation includes medical labyrinth of drug discovery and development process journals, research analysis reports, and pharmaceutical (about 8-10 years) for timely submissions to regulatory promotional materials. bodies – it has expertise in the documentation for the Investigational New Drug (IND) submission, the voluminous New Drug Application (NDA), patent Characterized by risky R&D process, intense management, and post release performance reports and competition for Intellectual Property, strict governmental quality records to regulatory bodies. regulatory process, and purchaser pressure, the highly complex pharmaceutical industry structure relies heavily on documentation to compile the voluminous body of TWB also handles meticulous documentation of R&D information during the lifecycle of a drug. The industry processes of various facilities of the same company. also needs successful medical journals and business This enables effective knowledge transfer and collaterals 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 future areas of expertise, besides creating corporate for the pharmaceutical industry, with the pharmaceutical presentations. market expected to touch $1.3 trillion mark by 2010. This expected market surge will bring about a fierce competition among the industry leaders, leading to TWB works closely with client teams located globally, increased R&D. This will inevitably result in newer and assists them in meeting their worldwide product products, both patent protected and generics. announcements and launch deadlines. TWB’s 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 this process, careful, comprehensive, and effective documentation is a perforce requisite for the timely “Knowledge is people, money, learning, flexibility submissions of regulatory documents. Moreover, post and competitive advantage. Knowledge is more approval, publication documents like medical journals relevant to sustained business than capital or labor. and promotional materials determine the successful And yet knowledge remains the most neglected market performance of a drug. asset of a business. TWB helps you unlock and share your technical knowledge with 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.”The Writers Block 1 1
  4. 4. Pharmaceutical Industry – Technical Publications Being one of the largest knowledge-driven industries, the Challenges and Solutions 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 animals. This Some of the greatest documentation challenges that industry consists of production and marketing of branded most pharmaceutical companies face today include: drugs, generics, non-prescription or over-the-counter medications, and related medical devices and  Timely submissions of documents to regulatory technologies. bodies  Accuracy and quality of documents submitted The industry continues to witness a constant growth,  Documentation of voluminous information in a despite the recent economic slowdown. According to frighteningly quick turnaround time IMS, pharmaceutical sales experienced a staggering  Quick and quality review process growth of 4.8% in 2008, compared to 6.6% in 2007. This growth rate was predicted to decline during 2009, with  Integration and management of documents 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 handling 1000 medical documentation, coupled with its large pool of 773 800 648 715 the industry expertise and experts, provides the (US$ in Billions) 605 World Market 560 following solutions: 600 499 393 429 400 200  Cost-effective knowledge documentation and 0 knowledge management 2001 2002 2003 2004 2005 2006 2007 2008  Integrated documentation process Ye ars  Simplified, multi-staged documentation and review processes However, the future of the pharmaceutical industry is not  Virtualization of work space enabling fast track bleak. According to a market analysis, the reviews pharmaceutical markets will more than double with figures touching $1.3 trillion in sales by 2020. This  Goal-driven approach to ensure quality and growth is predicted to be the result of R&D and business accuracy model revamp that will be brought about by the decreased dependence of blockbuster drugs (many of them are going off patent), bifurcation, value-added Benefits innovation, prevention-based products, new R&D technology, global regulatory process, made-to-order A leading pharmaceutical company, because of its production model, and emerging markets. association with TWB, has drawn the following benefits: Knowledge management and knowledge transfer are going to be critical to the quick release of a product in  Significant dollar saving, because of the quick the market and its market performance, in this forecast turnaround time market scenario. The way a company manages and  Significant hour saving, allowing increased transfers its knowledge-base will shape its position in the productivity highly competitive industry.  High-quality, error-free documentation because of TWB’s unquestionable expertise in medical writing, data and research management and its multi- “With the current operating environment, there 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 “With the current operating environment, there has never been a greater need for information on the activities of the global pharmaceutical industry.” – Centre for Medicine ResearchThe Writers Block 2
  5. 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 of physicians and caretakers to patients who use information vary depending on the type of product and prescribed drugs. If users have extensive 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 quality For example, a regulatory body needs to learn about documentation is imperative. the chemical specifications of a drug and the process involved in developing the drug, to evaluate if the drug has the clinical effect claimed and it does not have In today’s business scenario, technical publications are unacceptable side effects. often developed as an afterthought. This usually results in inaccurate and incomprehensible documentation, which, in turn, renders the users incapable of using the For users who start without scientific or product 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 product Accurate, readily understandable, and quality documents knowledge. 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 publications The faulty assumptions listed below result in are also used for marketing a product. Before a incomprehensible documents: product is released in the market, information about the product needs to be effectively communicated to  Developers know their products better than anyone the customers. else – due to time constraints and limited resources, many companies assign their documentation tasks to Well-designed, accurately presented, and attractive the programmers. This more often results in the marketing collaterals increase the market prospects of creation of technology-centered information, while a product and reduce support costs. 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.The Writers Block 3 3
  6. 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.The Writers Block 4
  7. 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. TWBs 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 – Products/Corporate  Layout and Design Profile  Installation Manual  Creating SLAs  Brochures and marketing collateral  Interface Document  Web content  Interactive Electronic Technical Manual (IETM) Business Documentation  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 Competition  Record Management Storage and  Installation and Configuration Guides Retrieval  Operations Manual  Forecasting  Sales Force Effectiveness  Market Assessments  Competitive Intelligence  Opinion Leadership  Emerging Markets - evaluation and researchThe Writers Block 5 5
  8. 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 DrawThe Writers Block 6
  9. 9. Industries Served TWB services a wide range of technology and knowledge driven industries, helping them meet their markets better, these include:  Banking, Insurance and Financial Services  ITES/ KPO/ BPO  Consulting and Business Services  Pharmaceuticals and Biotechnology  Defense, Aerospace and Hi-Tech Manufacturing  Process Manufacturing and Allied Industries  Education and Learning  Steel, Ship Building, Construction and Aviation  IT, ITES  Telecom and Digital Communications TWB has been the preferred technical documentation outsourcing company for: The TWB Building US Office: No: 4062, 19th Main Road, TWB HAL 2nd Stage, 11701 Norwegian Wood Drive Bangalore – 560008 Austin, TX 78758 India. Landmark: Behind Carlton Towers Telephone: Telephone: +91.80.40741400 / +91.80.41256367 +1.512.586.8357 Corporate Enquiries: corp@twb.inThe Writers Block 7 7