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New knowledge and information is constantly being added to the field of medicine by way of an ever increasing number of research studies, growing clinical experience, and new ideas and thoughts. All this information needs to be effectively communicated to different audiences, e.g. the physicians and other healthcare professionals, patients and consumers and the drug regulators. Medical writing is the discipline of writing scientific documents by writers in the field of medicine -- the “medical writers”. Medical writing is the activity of producing scientific documentation by a specialized writer. The medical writer typically is not one of the scientists or doctors who performed the research but the scientific information in these documents needs to be presented to suit the level of understanding of the target audience, namely, patients or general public, physicians or the regulators. Medical writing (also called medical communications, scientific writing, scientific communications) involves communicating often complex data and ideas in a clear, concise, credible, complete, and compelling manner. Medical writing is an essential and increasingly important activity required at every stage of developing a therapeutic product. It is both a science and an art and it requires an understanding in medical science and an aptitude for writing. In addition, a thorough knowledge of specific requirements for different types of medical documents, and keeping up to date with the relevant guidelines is a must. The demand for medical writing is growing steadily over the years. A medical writer, working with doctors, scientists, and other subject matter experts, creates documents that effectively and clearly describe research results, product use, and other medical information. The medical writer also ensures that their documents comply with regulatory, journal, or other guidelines in terms of content, format, and structure. More and more people are recognizing the benefits of working with professional, experienced, ethical writers. Quite simply, writers can enhance the speed and quality of document preparation. They are used by people who: Work in for-profit or not-for-profit companies; Have good writing skills, but limited time or project management skills; Have good clinical or scientific skills, but limited writing or English language skills; Can’t keep up-to-date with the increasing number of regulations and guidelines that affect the documents they need prepared; Leading journal editors, publishers, and researchers recognize the legitimate, valuable, and ethical role that medical writers play. Companies and institutions that hire writers need professionals who offer a dynamic union between scientific medical knowledge and written communication skills. Hospitals, academic medical centres, pharmaceutical companies and science publications and websites are potential employers. Are you a biotech company, a medical devices company or a pharmaceutical company looking for high-quality writing help at a cost-effective price? Outsourcing your regulatory, clinical, scientific and marketing communication documents to an authentic solutions provider, which is experienced in delivering writing help, across diverse therapeutic areas, would be the ideal solution to fulfill your writing requirements.
Medical writers may not be the original scientists who did the actual research, but work with the physicians/scientists involved in the generation of data, and help present the information in an appropriate manner. The importance of good medical writing cannot be ignored as science depends on clear and accurate reporting -- an otherwise meticulous research can appear flawed if it is poorly presented. The writer needs to have a clear understanding of the concepts and ideas, and be able to present the data and its interpretation in the way the target audience will understand. Writers combine their knowledge of science and their research understanding to present information at the right level for the target audience. Moreover, the writing needs to meet the specific requirements for different types of documents. Medical writing has become established as an important function in the pharmaceutical industry, because it requires specialized knowledge and skills to be able to write scientific documents which are well- structured, and presented in a clear and lucid manner. The demand for medical writing has gone up considerably in the last several years. The reasons are many -- more research studies are being conducted today in the biomedical field; pharmaceutical companies are developing more new drugs and medical devices, and various scientific documents need to be generated for submission to regulatory authorities during their approval process; the number of biomedical journals has gone up considerably and many more scientific articles are now published than before; similarly, with the addition of a new and a powerful medium like the ‘internet’ a lot of information is generated as ‘web content’ for professionals as well as for the general public. The term "medical writing" encompasses different kinds of work for clients in media, government, and industry. Pharmaceutical companies, medical-device manufacturers, and clinical-research organizations (CROs) all employ writers to prepare regulatory documents used to seek U.S. Food and Drug Administration (FDA) approval for drugs and devices. Our writers help doctors write research articles, monographs, and reviews on medical topics. Continuing medical education (CME) companies employ writers to produce educational materials and slide kits that doctors and nurses use to prepare for license renewals. Our writers produce sales training materials, press releases for industry, and fact sheets or web site materials for government organizations. Our writers also write about research discoveries for medical journals, web sites, newsletters, magazines, newspapers, and any other medium that includes coverage of health and medical issues.
Our medical and scientific writing group provides expert regulatory and medical writing help developed with the insight that each document we generate is an integral part of a much wider clinical-regulatory documentary process impacting the development of your product. The strength of our writing is also demonstrated by the multiple long-term engagements and extensive repeat business we are privileged to undertake. We offer the unique advantage of close collaboration with our global advisory team to build capabilities designed to cater to the specific requirements of our clients and deliver the highest quality of deliverables and customer service. Against other medical help websites, we recognize that our clients require stable yet flexible solutions to manage fluctuations in volume, timelines and document type. Our global team with experience of all major therapeutic areas provides expert guidance in a variety of writing help throughout the life-cycle of drug development and through to post-marketing activities. We welcome all types of projects and will deliver with the same impact. Our commitment to creating quality documentation according to the timelines you require means that our company is uniquely qualified to prepare a wide range of documentation to support global product development. We will deliver high quality documents on time according to your requirements. We ensure accuracy and clarity through rigorous quality control written into the standard operating procedures. The strength of medical writing relies on the experience and insight of the writers. Our team of experienced writers consistently produces accurate and timely documents that are compliant with client and regulatory guidelines. Our staff can support all your submission needs. Our writing staff works closely with your team in unison with our Clinical, Medical, Regulatory, and Quality Control groups to organize, write, edit, and produce precise documentation for a wide variety of therapeutic areas and devices. Our writing coordinators act as a central point of contact for a client, which allows us to build relationships with our clients and improve efficiency. We employ a highly qualified writing staff with PhD or master’s degrees, and a minimum of 10 years experience in clinical research and writing expertise. All our writers have extensive experience writing Phase 1 through 4 clinical trial reports in a broad selection of therapy areas and indications. They are skilled in managing the document preparation, review, and finalization process, including management of document review meetings. The writing team can also adapt to sponsor organizational models and processes, while maintaining a high standard of quality and adherence to applicable regulatory guidance. Our writing specialists have the ability to: understand and analyze complex scientific data; construct sound scientific discussion; communicate in clear language; prepare documents that are compliant with guidance and working practices; partner with teams to optimize the expert input from each member. Our cross-functional team of physicians and scientists has exceeded all client agreed deadlines over the varying therapeutic areas and project we have been serving on. Our expertise ranges from clinical-regulatory documents required to support clinical study protocols /amendments, investigator brochures, product labeling, ICDs, and clinical study reports and patient narratives, authoring of eCTDs, etc. We are a writing service provider offering wider-scope writing help including authoring of manuscripts and other post-marketing documents.
We have created a robust process, which ensures that our writing solutions are high on quality, right from inception to completion. Each project is assigned to a project leader who selects the writing team, based on the project specifications of the customer. The writing team is in turn supported by subject matter experts (medical, regulatory or scientific), graphic designers, document processors, biostatisticians and language experts. The final document is again reviewed by our quality control experts before submission. Our writers are committed to maintain high standards of excellence by making sure that our customers’ ideas are clearly communicated to their specified target audience. This is achieved through extensive research, writing of well-structured documents and consistent editing. Our writers work closely with their colleagues in the biostatistical, pharmacovigilance, project management, and clinical data management teams to deliver accurate, timely, and cost effective documents to the highest ethical and scientific standards. Our writers prepare clear, well-written documents designed to exceed expectations in terms of both content and formatting. Document development occurs with regular consultation to ensure that project needs are incorporated and client preferences for presentation are followed. All documents are prepared on time and are scientifically sound and fully compliant with any applicable regulatory guidelines. Our writers have a wide breadth of knowledge and experience drawn from the pharmaceutical industry, clinical research organizations, and academia. Our writing experts ensure that your scientific and medical communication materials are clear, concise, scientifically accurate and fully compliant with regulations, industry best practices and your corporate guidance. All documents produced by us undergo thorough scientific, statistical, editorial and quality control review. A team of project-specific reviewers is selected to ensure the materials are grammatically correct, scientifically logical and completely accurate. Quality reviewers also ensure compliance with audience-appropriate style as reflected in standard sources such as the AMA Manual of Style and the Oxford Style Manual as well as client-preferred style guidance.
With the healthcare and pharmaceutical industry expanding at a rapid pace, companies are looking for faster and more efficient ways to bring new drugs to the market. This has led to an ever growing need for high quality writing solutions. When you choose to outsource your writing help to us, you stand to gain numerous benefits, which include: Highly experienced writing staff with post-graduate degrees in pharmacy, medicine and other life science subjects; Expertise in preparing and writing of documents across a wide range of therapeutic areas; Completion of all writing projects within the given deadlines; Preparation of all regulatory and clinical documents according to relevant guidelines; Convenient, flexible and cost-effective pricing structure that allows you to pay per project or per word. Our company has managed thousands of writing projects in more than 30 countries in North and South America, Europe, Asia, and Africa. Unlike most writing solutions that rely on freelance contributors, we employ a large, full-time staff of experienced writers who have extensive backgrounds in most therapeutic areas. Our team of experts is uniquely qualified to help you compile, organize, write, edit, and produce a wide range of scientific documentation required to support your product development efforts. Our writing team consists of Pharm.D., M.D., Ph.D. and master’s level writers with diverse therapeutic backgrounds who can support preparation of a wide range of medical communication materials.
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