Regulatory Writing – An Essential Part of Clinical Research

• Regulatory writers often hold a PhD in life science, science-related, or medical field and work as individuals or for sponsors (e.g., pharmaceutical and biotech firms) or clinical research organisations (CROs).
• Regulatory writers create a range of clinical papers during a (possible) treatment’s life cycle, from summarising and reporting results from clinical trials to preparing regulatory submission paperwork. Regulatory writers also create post-approval reports on the therapy’s utilisation in patients if a regulatory authority approves the treatment. Investigator Brochures (I.B.s), Clinical Study Protocols (CSPs), Clinical Study Reports (CSRs), and the Common Technical Document are all examples of clinical documents created by regulatory authors (CTD).

Importance of Regulatory Writing

• The significance of producing high-quality regulatory papers is frequently overlooked. A CSR summarises the conduct and results of a clinical trial in a clear and unbiased manner and concludes many months, if not years, of hard effort by study teams. A well-written CSR will help Pubrica create high-quality submission papers, whereas poorly written or presented regulatory filings may cause regulatory clearance delays, costing the sponsor time and money.
• Regulatory writers are experts at meeting global regulatory requirements and adhering to guidance documents such as the Good Clinical Practice (GCP) and the International Conference on Harmonisation (ICH). They can comprehend, interpret, and often summarise complex scientific and statistical data while providing practical guidance. Some regulatory writers become specialists in a specific therapeutic area or condition and may assist sponsors and research teams with invaluable information.

References

Wood, Linda Fossati, and MaryAnn Foote, eds. Targeted regulatory writing techniques: clinical documents for drugs and biologics. Springer Science & Business Media, 2009.