Medical writing for regulatory submission in clinical research and its challenges

Regulatory submissions challenges in clinical trials

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 medication 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

Need for being concise with suitable presentation styles
Ascertaining the appropriate length of the document
Completeness and readability challenges
Time management

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