In the modern realities of the constantly changing field of medical circulation at the national and international levels in the pharmaceutical industry, there is an urgent need for a new type of generalist – CER writers. Such people have extensive clinical experience, knowledge of generally accepted scientific approaches to evaluating clinical trials and are also well versed in the requirements of regulatory bodies for the structure and content of clinical dossier documents. They can find and process huge amounts of scientific literature data, competently, logically, and concisely present their thoughts.
What is CER?
A Clinical Evaluation Report (CER) documents the conclusions of a clinical evaluation of your medical device. A CER consists of analyzed clinical data collected either from a clinical investigation of your device or the results of other studies on substantially equivalent devices.
As part of the clinical assessment, the manufacturer is expected to confirm or not that the device is fit for its intended purpose under normal conditions of use and that the identified foreseeable risks associated with the use of the device, as well as potential adverse events, are minimized and acceptable compared to the benefits of the intended use. All claims by the manufacturer regarding the device’s levels of clinical performance and safety must be supported by appropriate evidence.
What do CER writers do?
One of the most common areas of CER writing is developing documents for clinical trials of medicinal products: research protocol, report, synopsis, regulatory dossier, articles with research results, etc. Clinical trials are an integral part of the life cycle of any medicinal product. They are carried out both for state registration of the drug and other reasons, for example, when studying the possibility of expanding the drug’s medical use indications. The relevant regulations regulate the rules for conducting clinical trials.
What should be in the clinical report?
In its structure, this study resembles a scientific article. It begins with a brief statement of the problem and the justification for its research. The article contains general information about the sponsor, monitor, researcher, and medical institutions participating in the study. Then the goals and objectives of the study are formulated.
Further, it is necessary to describe in detail the methodological part of the study. Also, the protocol requires a description of the studied drug with an indication of the dosages and the scheme of its use, designate the expected duration of the study, the required number of subjects, and the criteria for their selection and criteria for termination of the study. Like scientific publications, the research protocol should contain information about the statistical processing of the data, describing all the statistical methods used.
It is crucial to reflect in the text of the protocol the ethical aspects of this study, which will be the object of close attention of the expert council or ethics committee. The protocol may reflect the issues of financing, insurance, and the publication of research results in scientific journals.
Skills Needed for a CER Writer
In addition to communication skills, a CER writer needs a clear understanding of the requirements for scientific publications, including a basic knowledge of statistics. For a specialist of this kind, practical computer skills, proofreading, text editing experience, and excellent command of the English language are also required. In addition, a medical writer must have a scientific background and, preferably, an advanced degree in medicine or biology.
Where to find CER writers?
The most popular resources for finding CER writers and other professionals are freelancing platforms like Kolabtree. Finding a CER writer website like KolabTree that is made of experts in the fields and professionals is ideal.
You could ask your freelance friend for advice or search for “freelance sites” on Google, and this site is sure to catch your eye.
Conclusion
The healthcare industry does not tolerate inaccuracies, which is why CER writers are highly regarded. These are former and practicing doctors, pharmacists, and nurses who know how to work with text. They leave medicine for freelance or combine clinical practice with writing articles. Don’t ask too much, be humble, and reward CER writers generously for their efforts.
