Regulatory Medical Writing involves writing a study protocol and/or a clinical study report (CSR) of a project. However, sometimes the medical writer has to tackle multiple projects with converging deadlines and all the study teams demanding more and more of his time.
So, here are the medical writing tips to manage multiple projects efficiently.
Identify the documents which are the most urgent and have the highest impact in a study. Prioritize them over those with the least impact.
Many authors choose to hire professional medical writers when writing their research for publication. But, why they do so? Do they lack the proficiency in writing a research paper? Or they are not a native English speaker? Or their research work leaves no time for writing their research document?
If you are still doubtful about hiring a professional medical writing services, this piece is for you.
With respect to the clinical trials, their adequate reporting is important in the pharmaceuti
Regulatory medical writing is an integral part of Medical Communications, but is often overlooked. In simple terms, it involves writing of the documents required for the approval of drugs by the regulatory authorities.
The regulatory authorities like FDA, Health Canada, European Medicines Agency and others assess the efficacy and safety of the drugs through all phases of their clinical trial and ultimately approve their use in patients.
Regulatory writing helps these authorities in doing
Narrative writing or writing patient safety narratives is an integral part of any clinical study report writing. Before dwelling into its guidelines, let us first understand what it is and what importance it carries in clinical research.
In simple terms, a narrative is a brief summary of the adverse events experienced by the patients during a clinical trial of a drug. It is submitted along with the clinical study report to establish any causal relationship between the events experienced by the