Medical writer

Role of a Medical Writer in a CRO

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Contract Research Organisations, otherwise called as CROs, provide contract-based services for Pharmaceuticals, Biotechnology and Medical devices companies at various stages of their drug development. The activities that a CRO undertakes include preclinical studies, clinical research and clinical trials, regulatory activities, and pharmacovigilance. CROs have technical competency and expertise in performing these activities. The company that outsources these overwhelming activities to a CRO is called a sponsor or client company. The CROs add value to the sponsor companies by reducing the time required to bring the drug into the market.

CRO’s usually hire highly qualified personnel holding life science related degrees. Among the various staff, medical writers play a crucial role in a CRO in handling the variety of documents involved in the drug development and its reporting. A medical writer who understands the drug or device development process and regulatory activities is an important asset for the team. The key function of a medical writer is to develop accurate, clear, and compliant documents as per the project and the regulatory requirements.

A medical writer in a CRO is required to create and maintain a wide spectrum of documents, few of them include:

  • Protocol writing: It is a detailed document that demonstrates the guidelines for conducting the clinical trial, it contains the study objectives, design, methods, assessments, and statistical data.
  • Investigator’s brochure: It is an updated document that outlines the entire clinical trial process to the investigator.
  • Clinical Study Reports: Popularly called as CSRs are detailed documents that describe the methodology followed and the results obtained in a clinical trial.
  • Informed consent forms: The document reflects the study participant’ agreement to be a part of the study, and contains the purpose of the research and his/her role, which is usually explained to them before seeking their willingness.
  • Efficacy or Safety summaries: These crucial documents are official records of adverse reactions occurring due to the investigational drug during the clinical trial phase.
  • New Drug Applications (NDA): NDA is submitted by a sponsor company to the FDA for approval to sell and market the drug. The NDA includes detailed information about safety, efficacy, benefits vs risks, and package inserts.
  • Patient Narratives: These documents are summaries of adverse events experienced by patients during the clinical trial. Narrative writings involve patient profiles, review of data sources, and identification of events which require a narrative. 
  • Package Inserts: These are documents included in the package of a medication and provide information about that drug and its use.
  • Manuscripts – This document is a publication-ready account of the important findings of the study. The manuscript is published in journals to let the peers know about the study and its results.  Clinical research manuscripts usually include: Introduction, Methods, Results, and Discussion (IMRAD)

Medical writers in CRO collaborates with bio-statisticians, medical specialists, scientific experts and sponsors to develop high quality documents abiding to the ICH GCP requirements. Here are few considerations to be hired as a medical writer in a CRO:

  • Background – Life sciences degree like medicine, pharmacy, biotechnology and chemistry are usually preferred.  
  • Experience – Previous experience or knowledge about clinical trials, regulatory affairs or pharmacovigilance can be an advantage.
  • Certification – A certification program in medical writing may provide necessary exposure to the various clinical research and regulatory documents.
  • Soft skills – Apart from good writing skills. a medical writer must have good oral communications and project management skills.

CROs usually aim to proliferate the markets with their newly launched products, and preparing these communication materials becomes crucial for creating the identity for the products. Medical writers perform a key role in enabling this process. If you are the one who is looking out for an adventurous profession and are good in juggling multiple works, medical writing is the profession you must explore!

Scientific Writing

5 Thumb Rules for Writing Winning Scientific Abstract

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A scientific abstract conveys the summary of a scientific paper to the audience without reading the entire paper. An abstract is as an important piece of writing that boosts the visibility of a study. They serve as a filter for the researchers to find the appropriate study in lesser time.  Let us investigate a few points that might help in writing a winning abstract,

Rule 1: Structure it well:

A structured approach is necessary for writing a well organised abstract. The general template used for an abstract writing includes:

  • Background or Introduction – Provide the purpose of your study and the research questions/challenges that you tried to address in your study.
  • Methods – A brief about the research methods used to conduct your study.
  • Results or Findings– Describe your major findings or discoveries in the study.
  • Conclusion – Include how did your study contribute to the field. It is the take-home message of your project and its impact.

*Certain papers provide their personalised templates.

Avoid: Avoid copy-pasting the content from the main paper craft a standalone abstract.

Rule 2: Follow the guidelines

Word count, font size, spacing, units and abbreviations, do not miss any of them. These are the things that judge your attention to detail. The following are a few general guidelines:

  • Abstracts should be formatted as a single paragraph.
  • The abstract should be in a block format (no paragraph indentations).
  • Centre the word “Abstract” at the top of the page with double spacing between the heading and the abstract.
  • Mostly, the abstract page immediately follows the title page.

Avoid: Avoid including references unless the guidelines demand. This allows to maintain the word limit and makes your abstract simpler.

Rule 3: Title that grabs the attention

Remember the reader reads the title first and follows the study. So, your title must be eye-catching, simple, clear, and informative. It should reflect all the important points covered in the study.Remember the title with active verbs grabs the reader’s attention.

Avoid: Avoid having a lengthy title. A good title contains less than 15 words.

Rule 4: Apply No more No less concept

Ensure that the abstract narrates all the parts of your paper. Provide a brief about why and how the study is conducted, study findings and why is the study important and remember not to overstate any of them. For example, an abstract usually does not include citations.

Avoid : Avoid using lengthy background, redundant phrases, unwanted adverbs/adjectives, repetitive information, and acronyms in your abstract.

Rule 5: Keyword usage

Include keywords, which people are likely to use when searching for papers on your topic. This supports the search engines to rank your document and make it easier for others to find. Keywords that are relevant to the topic should be added in a separate line after your abstract.

Avoid: Avoid using too small or long keywords. For example, if your study is about gestational diabetes, usage of keywords like “diabetes”, “blood glucose” are too broad, and your paper may not be visible on top in the ocean of papers on diabetes.

To write an abstract that summaries the entire study in one self-contained paragraph is a skill. To develop the skills of writing an abstract require practice. If you are willing to learn how to write a scientific abstract, I-CME – Online Training in Medical Writing and Healthcare Communications, invites you for a challenge.

“Pick up any scientific paper available online and write an abstract on your own. Do not copy/look into the abstracts that are already written. Submit it to us and our expert scientific writers will review and provide the feedback. Equip your skills necessary to write a concise and informative abstract.”