Mediclin Clinical Research

Medical & Scientific Writing

Let's discuss What is Medical & Scientific Writing?

People should know there is significant difference between Medical and Scientific writing.

Medical writing is about developing clinical and scientific documentation in a standard, comprehensive, reliable, skilled and convincing manner. Whereas scientific writing means writing about basic sciences, drugs and technological innovation for common readers. Medical writing mostly involves creating well-structured scientific documents. These scientific documents include clinical research documents, content for healthcare websites, health magazines, journals as well as news. Wide range of documents can be involved in this, such as regulatory and research-related documents, disease or drug-related educational and promotional literature, publication articles like journal manuscripts and abstracts, content for healthcare websites, health-related magazines.

There are different types of Medical Writings:

    Regulatory Medical Writing
    Educational Medical Writing
    Medico-marketing writing

Regulatory medical writing involves mostly in developing documents related to drug, devices and biologics in order to get approval from regulatory bodies. This includes clinical trial data, regulatory submission documents, post approval documents, etc. Regulatory documents include Non clinical reports, Standard operating procedures, investigators brochures, protocols, ethic submissions, clinical study reports, regulatory submissions, reimbursement submission.

Educational medical writing requires preparing documents related to drug, devices and biologics for general audiences, and for particular audience’s for instance health care professionals. Investigator summaries, publication plans, abstracts, slides, posters, manuscripts, advisory board reports, website content and patient information are the educational documents.

Medico-marketing medical writing is mostly about developing marketing material for ethical promotion of a therapeutic product. Product monographs, training material for the sales force, reference compendium, patient information leaflets (PILs), CME slides, leave behind leaflets are the documents developed.

Scientific writing is a highly specialized technical writing by a scientist or science specialist, which is reviewed by other scientist. The main aim of science writing is to narrow the gap between the general public and those with scientific expertise.

Scientific writing involves working on popular science books, magazines, and newspapers covering scientific information, innovation or technological advances, Science programs on Television or Radio, Internet i.e. -websites, blogs, e-pubs and Digital science communication (videos, podcasts, slideshows and whiteboard lectures).

We should know that there four main types of scientific writing are descriptive, analytical, persuasive and critical.

The simplest type of scientific writing is descriptive. Its purpose is to provide facts or information.

Analytical scientific writing

Most scientific writing is also analytical. Analytical scientific writing includes descriptive writing, but also requires you to re-organize the facts and information you describe into categories, groups, parts, types or relationships.

Persuasive scientific writing

In most scientific writing, you are required to go at least one step further than analytical scientific writing, to persuasive scientific writing. Persuasive scientific writing has all the features of analytical scientific writing, with the addition of your own point of view. Most essays are persuasive, and there is a persuasive element in at least the discussion and conclusion of a research article.

Critical scientific writing

Critical scientific writing is common for research, postgraduate and advanced undergraduate writing. While persuasive scientific writing requires you to have your own point of view on an issue or topic, critical scientific writing requires you to consider at least two points of view, including your own.

A medical writer should have proper medical writing skills.
Medical writing skills include the following:
Domain knowledge
Substantial knowledge of varied therapeutic areas, regulatory/scientific guidelines and key statistical concepts.
Writing skills

Logical with accurate data interpretation and representation.

Keeping yourself up to date

Keep alongside of new relevant information, and undergo regular training and online courses to enhance your skills.

Knowing your audience

Understand your audience. Whom are you writing for – regulators, scientists, doctors, or consumers and the general public?

Data integrity

Maintain accuracy, consistency and security of data – using stringent document management systems.

An independent outlook

Performs critical content reviews, correctly interprets results, identifies potential limitations and discusses unexpected findings.

Clarity

Establishes clear objectives, organizes ideas and embraces creativity. Learn how to write quality content that your readers will understand.

Interpersonal skills

Well-honed verbal, non-verbal and listening skills for problem solving, negotiation and decision-making.

Literature search

Well-planned search strategy is used, appropriate keywords and a variety of sources when researching journal articles and medical research papers.

Project management skills

Highly organized, proactive, respects metrics driven timelines and accountability for quality. Accepts responsibilities and delegates efficiently.>

Medical writing demands special skills to produce well-structured documents with clear and concise information. Medical writers must have adequate knowledge of the therapeutic areas, the drug development process, pharmacology, drug safety, statistics, and regulatory guidelines.

Science writing does not deal with such a highly specialized technical writing. It is aimed to inform the general public about the important scientific issues in an easy to understand language.
Hence, all medical writing writers are science writers but all scientific writing writers are not medical writers.

Scientific Writing includes all writing that deals with science such as medicine, chemistry, biology, physics etc and Medical writing is about writing on subjects associated to health & medicine.

Or we can also say, Scientific Writing deals with writing about basic sciences, drugs and technological innovation for common readers, while Medical Writing is all about developing clinical and scientific documentation in a standard, comprehensive, reliable and convincing manner.

Effective medical writing for patients ensures the audience retains a high proportion of the information presented. Improved patient understanding results in increased recall of information, patients’ satisfaction, adherence to therapy, and better health outcomes.

Medical writing involves creating well-structured scientific documents that include clinical research documents, content for healthcare websites, health magazines, journals and news.

Medical writing for the pharmaceutical industry can be classified into two types:
1)Regulatory medical writing 2)Educational medical writing
3)Medico-marketing (Medical Affairs) writing

What is Regulatory medical writing (Medical & Scientific Writing)

Regulatory medical writing means creating the documentation that regulatory agencies require in the approval process for drugs, devices and biologics. Regulatory documents can be huge and are formulaic. They include clinical study protocols, clinical study reports, patient informed consent forms, investigator brochures and summary documents (e.g. in Common Technical Document [CTD] format) that summarize and discuss the data a company gathers in the course of developing a medical product.

What is Educational medical writing (Medical & Scientific Writing)

Educational medical writing means writing documents about drugs, devices and biologics for general audiences, and for specific audiences such as health care professionals. These include sales literature for newly launched drugs, data presentations for medical conferences, medical journal articles for nurses, physicians and pharmacists, consumer education and programs and enduring materials for continuing education (CE) or continuing medical education (CME). It plays a very important role in promotion of various pharmaceutical brands both to the HCPs and the consumers. Different types of communication use different media to present the writings.

Medico-marketing (Medical Affairs) writing involves developing marketing material for ethical promotion of a therapeutic product. The documents developed may include product monographs, training material for the sales force, reference compendium, patient information leaflets (PILs), CME slides, leave behind leaflets (LBLs), etc.

Other types of medical writing include journalism and marketing, both of which can have a medical writing focus.
Regardless of the type of medical writing, companies either assign it to an in-house writer, or “outsource” it to a freelance or contract medical writer.

Medical writing as a function became established in the pharmaceutical and contract research organization industry because the industry recognized that it requires special skill to produce well-structured documents that present information clearly and concisely. All new drugs go through the increasingly complex process of clinical trials and regulatory procedures that lead to market approval. This demand for the clear articulation of medical science, drives the demand for well written, standards-compliant documents that medical professionals can easily and quickly read and understand. Similarly, medical institutions engage in translational research, and some medical writers have experience offering writing support to the principal investigators for grant applications and specialized publications.
Medical writing is a profession dedicated to the communication of medical, scientific and health information, including research reports, consumer (patient) information, and regulatory documents.

Difference Between Medical Writing and Scientific Writing

Medical writing is a much more specialized area of scientific writing where as scientific writing is writing about science regardless of whether it is about medicine, chemistry, Physics etc. Thus, all medical writers are science writers while all science writers are not medical writers. For example if you draw two concentric circles, one larger than the other. The larger one represents scientific writing and the smaller (inner) circle signifies medical writing. Scientific writing includes all writing that deals with science such as medicine, chemistry, biology, physics etc and medical writing is about writing on subjects associated to health & medicine.

Now about Medical Writing, the guidelines state that medical writers should avoid plagiarism and should not confuse the readers. Medical writers, according to the guidelines, may also delegate the responsibility of submission and publication of the articles to journals. A medical writer is to be held responsible for the quality of publications.

A medical writer is a person who applies the principles of clinical research in developing clinical trial documents that effectively and clearly describe research results, product use, and other medical information. The medical writer develops any of the five modules of the Common Technical Document. The medical writers also ensure that their documents comply with regulatory, journal, or other guidelines in terms of content, format, and structure.

Now about Scientific Writing, this writing follows certain conventions related to format, citation, design, voice, tense, concision and organization that may differ from writing in other contexts. The best way to learn these conventions is to read representative samples (published or otherwise) within each discipline.

The four main types of Scientific writing are descriptive, analytical, persuasive and critical. Each of these types of writing has specific language features and purposes.
Scientific writing can include:
1)Peer-reviewed journal articles (presenting primary research)
2)Grant proposals (you can’t do science without funding)
3)Literature review articles (summarizing and synthesizing research that has already been carried out)

What counts as scientific writing (Medical & Scientific Writing)?

Scientific writing is not just writing about science; it is the technical writing that scientists do to communicate their research to others. Scientific writing is predicated on the rigors of scientific inquiry, so it must reflect the same precision as that demanded in the research process.

“With Mediclin Clinical Research, you can always count on working with a Dream Team of the best and most reputable experts in the industry. The Medical Writing team is responsive to our every need through all phases of development.”

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