Writing Medical Content For Clinical Research | pepgra

-

Medical content Writing is an integral component of clinical research that is essential for effectively taking research related scientific communications to the target audience like medical specialists and health care professionals. Effective and well-structured medical contents with appropriate research design and reference support is imperative for every aspiring medical researcher to publish their clinical research studies in reputed national and international medical journals.

WRITING MEDICAL CONTENT FOR CLINICAL RESEARCH

Medical content writing in Clinical Research requires proper academic background in the field of medical science and specialized writing skills that needs to be possessed by the medical researchers and clinicians. The medical content writer must also possess good understanding of the clinical perspectives like patient benefits, safety measures and needs to present the medical research contents from the view point of medical or health care professionals.

This medical writing Services quick guide is intended to help the clinical practitioners and researchers understand the nuances of clinical research writing that will enable them to make effective clinical research paper presentations to their intended targeted audience.

Essential Regulatory documents of Clinical Research

Health care professionals and researchers involved in the clinical research must gain better knowledge of various essential aspects in the preparation of regulatory documents involved in the research study. Some of the important documents that are essential for conducting and presenting clinical research studies include,

  • Clinical Research study protocols
  • Standard Operating Procedures (SOPs) that covers all the features of the research study like research design, methodologies and the conduct and report presentations of the clinical trials
  • Clinical and non-clinical summaries and overviews relating to the research for the concerned regulatory authorities.
  • Ethical standard protocols followed in the clinical research trials involving humans and animals in accordance with the national standards laid down by the concerned regulatory authorities like ICMR’s Ethical Guidelines for Biomedical research on human participants
  • Narratives concerning safety of patients involved in the clinical research
  • Documents relating to pharmacovigilance and safety updates
  • Patient informed consents and safety brochures for patients participating in the clinical research

Instructions for Clinical Writing

The medical writers must have a good understanding of the clinical research goals and needs to ensure that the research ideas, methodologies and the scientific results of the clinical research are conveyed precisely in order to maximize the impact of medical research contents.

This quick clinical guide for healthcare professionals and researchers provides a list of diverse documents necessary for conducting a well-structured clinical research paper ranging from study protocol, research design, Investigator’s brochure to clinical research reports.


The clinical research paper must have following the features

  • Structured abstract section briefly describing the nature and scope of the research, concepts, methods adopted and clinical findings
  • Appropriate sub-headings indicating the study background, research objectives, samples used and analytical methods
  • Brief introduction about the research indicating the scope of the study
  • Review of literature to provide the reasons and motivations for undertaking the particular clinical research study
  • Sampling methods used for sample size calculation with inclusion and exclusion criteria used while selecting the participating patients for the research study
  • Period with month and year of conducting the research along with the place of research conduct.
  • Statistical methodologies, data analysis and interpretation techniques utilized in the study
  • Medical terminologies with universally applicable disease and health care related abbreviations
  • Relevant Tables and figures providing important statistical data to support the research
  • Outline of the study and important scientific developments related to the research with potential impact on patient care and public health
  • Complete discussion and conclusion section involving the usage of authentic medical contents with proper terminologies
  • Complete Bibliographic section indicating the research title, author, journal published and research year for the literature references used in the paper

Tables and Figures

Clinical research writing must include pertinent tables with appropriate titles, row and column headings with units of measurement and statistical measurements properly abbreviated and place below the respective column headings.

Randomized Clinical trial paper writing must include essentials information involving protocols, assignment of inventions by clearly stating that the particular study protocol has prior approval from the concerned ethics committee of the research institution. The research paper must also mention that proper written consents relating the study have been obtained from the patients participating in the clinical research.

The research writing can have a brief acknowledgement section for acknowledging the specific scientific and financial assistance and the help the concerned researcher received in the preparation of manuscripts.

The discussion section deals with the interpretation of the research findings and the medical researcher must take due care not to repeat information given in the Results section. This section can give comparison of new findings with the existing results in this topic and must also mention any limitations, constraints and flaws of the study. Based on the discussion, the researcher or healthcare professional must give their recommendations that are relevant for the topic of the research study.

Professional medical research help is available for health care professionals and researchers who have time, resources and writing skills constraints. Expert writing service companies specializing in the writing of medical contents for clinical research studies can offer customized service to the need and requirements of the medical researchers.


To Read More : 

Clinical Research Organization Services

Medical Device Regulatory Affairs Services

Pharmacovigilance Services

Clinical Data Management Companies


Comments

Post a Comment

Popular posts from this blog

Difference between Clinical Research Organization and Contract Research Organization(CRO)?

-
Image
1.  A  contract research organization (CRO) organization that offers clinical trial and all kind of research support services outsourced on a contract basis to the pharmaceutical, biotechnology, and medical device industries and also serve government institutions, foundations, and universities.  2.  While contract research organizations can span the whole pharma pipeline from drug discovery to clinical trials and beyond, a clinical research company mostly manages clinical trials. 3. A contract research organization (CRO) sometime known as clinical research organization is the company or organization that helps conduct research for a sponsor company. This research can be ranges from pre-clinical development of new products to post marketing research activities. 4. CROs Play a major Role in Drug Development   5. One of the important ICH GCP guideline is followed to conduct clinical studies 6. A clinical research company mostly manages clinical trials.   To Read More: clinical resear
Read more

THE ROLE OF REFERENCING IN SCIENTIFIC WRITING

-
Image
The Role of Referencing in Scientific Writing Scientific writing  makes up an integral element within research. Of late, the pace at which findings of a research is communicated through diverse mediums such as thesis, books, conference papers and journal articles has substantially increased with widespread developments in technology and medicine. The findings from these researches are usually perceived as harbingers of development in the academic and scientific domain, driving further research or action. As is the case in any kind of academic writing, scientific writing too warrants the need for adequate references to correlate the findings with experiments conducted in the past or to indicate what researchers have said about a particular phenomenon. As a matter of fact, referencing and bibliography are vital components within a scientific paper. This article is essentially an attempt to highlight the key features, benefits and limitations of most commonly used referencing tools
Read more

TIPS FOR SCIENTIFIC MEDICAL WRITING

-
Image
Scientific medical writing involves writing detailed information about the essential medical sciences, drugs and latest technological innovation within the field of drugs for a variety of audiences including medical specialists and health care professionals. This scientific information is written for publication within the medical journals, medical news, and regulatory documents. MEDDEV (2.7/1) guidelines for CER documentation describe the various stages of planning, assessment, and evaluation of clinical data about medical a device to validate the clinical safety and functional performance of the concerned medical device. Some of the important procedures and documents involved in the CER development process include • Standard operating procedures for carrying out Clinical Evaluation • Quality System related procedures and protocols • Outlines for Clinical Evaluation Plan (CEP) and Clinical Evaluation Report. • Pre-market and post-post market CER • Clinic
Read more