Position Paper onValue of Technical Publications inthe Pharmaceutical Industry
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.”The Writers Block www.twb.in 1 1
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 areThe Writers Block25% of components and supplying around www.twb.in 2 subassemblies to state-owned companies.
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.The Writers Block www.twb.in 3 3
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 www.twb.in 4
TWB ServicesTWB is India’s leader in technical communication outsourcing and education. TWB offers a complete suite of services that allowour customers to effectively publish their technical knowledge with their people and processes. TWB’s customers range fromGlobal 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 – 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 researchThe Writers Block www.twb.in 5 5