Regulatory medical writing in clinical trials requires medical writers to possess sufficient knowledge of the regulatory guidelines of concerned authorities of specific countries and needs to have dedication and commitment to handle large volumes of regulatory data. A professional regulatory writer needs to have sufficient understanding of the drug development process to determine the important documents that need to be written and submitted for regulatory submissions.
Regulatory submissions challenges in clinical trials
Regulatory Writing and Publishing poses many challenges for the medical writers in the writing and development of critical documents like Clinical Study Report, Investigator’s Brochure, and clinical trial protocol development and in the preparation of documents for FDA meetings and briefings.
The Clinical Study Report (CSR) is a critical document that provides an integrated report comprising the clinical and statistical description of the investigational study of therapeutic or prophylactic drugs in a single report with relevant tables, figures, and appendices. A medical writer will face challenges in understanding the guidelines and statutory requirements and also developing suitable document template that covers all current regulatory requirements.
Investigator’s Brochure is an essential regulatory document that provides an overview of the clinical and non-clinical findings of the trial study and is primarily used as an investigator guide to assessing the risks and benefits of the product under investigation. The major challenge commonly faced by the regulatory medical writer in the preparation of Investigator’s brochure include
Preparing briefing documents for FDA meetings is another major challenge faced by the regulatory medical writers as it involves extensive writing relating to new products description, clinical pharmacology, mechanism of action, pharmacokinetics, clinical review on its efficacy, safety, Benefit-Risk summary, and assessment.
Clinical Trial Protocol Development is a complicated process that involves proper planning and diverse document requirements during the pre-clinical and clinical stage as specified by the regulatory authority, which includes
Regulatory medical writers need to have an adequate understanding of the important activities involved in Clinical Trials and Good Clinical Practice, which may present them challenges like large time requirements to develop high-quality medical contents specific to the target audience.
Also, Pre-clinical and scientific reports pose challenges to the regulatory medical writers as these reports need to have accurate facts, statistical data, relevant tables, and figures.
Comprehensive Regulatory Writing Services
International regulatory writing firms can offer immense assistance to the companies conducting clinical research trials by helping them in the writing, editing, organising and the compilation of broad range of essential medical and scientific documentation like
Thus, it is advisable for the healthcare, pharmaceutical, biotechnology, medical device, CROs companies to entrust these complex regulatory works to a global regulatory writing services team of experts, to meet the various challenges like stringent regulatory body requirements, multiple agencies approval prerequisites and timely submission of essential documents.