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Each of the above types of medical writing is meant for a distinct set of audience, e. Hence, the language used and the level of technical information has to be appropriate to the level of understanding of the respective audience. For example, while documents meant for medical professionals non scientific medical writing services regulators can be highly technical and can include scientific data and its explanation, those meant for patients and general public need to simple and free of technical jargon.
In addition, documents for regulatory submission are required to fulfill set formats and structures, and their contents are guided by regulatory rules and guidelines. Hence, a medical writer involved in the preparation of these documents needs to be conversant with the regulations and prescribed formats for such type of documents.
It is possible, therefore, that the knowledge and skills required for writing different types of medical documents are different, and one may decide to specialize in a specific type of medical writing, depending on one's aptitude and liking.
Who requires medical writers?
Medial writers mostly work with the pharmaceutical industry. However, there are many other setting in which medical writers are required: This is also a profession which one can practice either independently as a freelancer, or as an employee in an organization, depending on one's experience, level of expertise and liking.
So, learning medical writing can be the beginning of a life-long profession. Requirements for becoming a Medical Writer The basic pre-requisite for becoming a medical writer is of course, familiarity with medical concepts and terminology.
An academic qualification in one of the life sciences such as medicine, or paramedical sciences such as pharmacy, microbiology, nutrition and dietetics, biochemistry, biotechnology can provide the right background which makes the writer familiar with scientific concepts and research data.
Another important pre-requisite is the ability to write. As the basic requirement on the part of a medical writer is to communicate scientific information to the target audience, some degree of command over the language, reflected by an ability to write grammatically correct text, and an ability to express and present information clearly and succinctly is most important.
Writing technical documents related to specific therapeutic area e. However, since medical writers seldom work in a single therapeutic area, it may not be possible for one to have a prior thorough knowledge of each therapy area.
It would be a good strategy to have basic knowledge of different medical specialties, and build upon that as one goes on writing documents in different therapy areas. Drug development processpharmacology, drug safety — medical writers involved in the preparation of clinical research and regulatory documents such as trial protocols, investigator brochures, clinical study reports of different phases I-IV of clinical trials, efficacy and safety summaries require a thorough understanding of the drug development process, the clinical research and various guidelines related to these.
Those writing reports of early clinical development also require a good grounding in pharmacology and an understanding of pharmacokinetic concepts.
Similarly, medical writers writing safety reports need to understand the drug safety process and requirements of safety reporting prescribed by different regulatory authorities. Statistics — Medical writers come across statistics when they write about clinical trials and when they write about research studies.
The statistical results of clinical research must be communicated in a manner that allows clinicians to assess critically the quality and reliability of both the study design and any conclusions that might affect clinical practice. Every medical writer has to deal with confidence intervals, regression analyses, randomization schemes, P values, and t-tests.
An understanding of statistics is necessary for good medical writing. One of the ways of developing this is attending workshops on medical statistics conducted by professional statisticians.
In addition, the national regulatory authorities have their own specific requirements. These instructions require thorough reading. Information about these technical requirements is usually available on the ICH website or websites of the Regulatory Authorities. Moreover, new guidelines emerge, old ones are revised, and a medical writer has to keep up to date.
Publication guidelines like Good Publication Practices, guidelines for reporting clinical trials e. In addition, all medical journals have their own instructions for authors.
In addition to understanding the scientific aspects, the writer needs to present the information in a clear manner and at a level of understanding appropriate to the target audience.
Use of grammatically correct language, simple and short sentences, active voice, appropriate punctuation marks, and a logical flow of ideas can go a long way in making the information understandable to the readers.
Avoiding the use of highly complex technical jargon also makes the writing more lucid, especially for nonmedical audiences.Our skilled medical writers are adept at producing the highest quality scientific documentation for even the most demanding audiences.
– clinical, non-clinical and CMC sections. Clinical Writing Protocols, Informed Consent Forms & Patient Information Get in touch to find out more about medical writing. All Services Biostatistics View. Medical writing is an integral part of clinical research. The Medical Writing Unit at TFS is fully qualified and experienced in the production of Clinical Study Protocols and Study Reports according to ICH GCP guidelines as well as a wide range of medical and scientific documentation required to support product development efforts.
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. People who searched for Medical Writing Degree and Certificate Program Overviews found the following resources, articles, links, and information helpful. Exploring the Scientific Art of Medical Writing: Blending Complexity with Simplicity 16th & 17th June J W Marriott, Juhu Mumbai Medical Writing Services PAREXEL Bindu Narang Head, Regulatory Affairs and Aggregate Safety Industry Non- Member q Academia / Government q.