Clinical Evaluation Report Writer (CER Writer)
Medical Device Clinical Evaluation Report writer must be from biology, science field with experience in regulatory, development, usage on patients or design technology.
By way of an ever-increasing number of research studies, growing clinical experience, and new ideas and thoughts, new knowledge and information are constantly getting added to the field of medicine. All these scientific information needs to be effectively communicated with the target audiences such as physicians, the general public, healthcare professionals, drug and medical device regulators.
Medical writing involves writing various types of regulatory and research-related documents; disease or drug or device-related educational literature, contents of healthcare websites, healthcare magazines and so on. It is important that a clinical writer requires an understanding of medical concepts and terminology, knowledge of relevant guidelines and good writing skills.
Regulatory clinical writers create documentation that regulatory agencies require in the approval process for devices, drugs, and biologics. Regulatory documents can be huge and include clinical study reports, clinical evaluation reports and so on that a company gathers in the course of developing a medical device or a product.
Need & Importance of a CER Writer
- The individual will be able to effectively communicate scientific and regulatory information in a clear and lucid manner to the regulatory authorities;
- He/she will be capable of performing literature search in various databases such as Cochrane, Pubmed, Medline, EMBASE etc. They know what exactly they are looking for, they know where to search, planning a search strategy to bring up the most useful information;
- The person can perform interpretation of data, do the clinical data appraisal and analysis of the data and present the results in tables, texts and graphs so that the target audiences understand what it means;
- He/she will be an expert at giving truthful and complete information including negative findings, following copyright laws, not indulging in plagiarism and so on;
- The person will be skilled at using software such as MS word, referencing tools, drafting tools, analysis tools and so on;
- He/she can work across teams as well as independently;
- The individual will be good at time management and meeting deadlines and commitments.
Therefore, medical device MedDev 2.7/1 rev 4 or MDR article 61 clinical writing is a combination of science and art that requires an understanding of regulatory aspects and keeping up to date with relevant guidelines, which is a must.
Role of I3CGLOBAL in CER Report Writing
- Qualified and experienced clinical writers who can plan and execute clinical evaluation, meeting the regulation and guidelines per the manufacturers’ requirements;
- Experienced in various software tools enabling unmistakable, organized and efficient way of documentation;
- Experts at literature search and appraisal, interpretation and analysis of data;
- Diligently work towards timely project completion;
- Provides well-structured procedure, SOPs, and associated templates;
- Guides and supports manufacturers on timely CER updates;
- Provides truthful and complete information following copyright laws and without indulging in plagiarism.