Abstract 

With an increasing global focus on clinical data transparency, regulatory professionals are now more often engaging with clinical trial transparency (CTT) teams, an established but often unfamiliar area within regulatory operations. 

This article emphasises the vital role of the CTT function as an integral part of the regulatory submission journey, starting with early disclosure-by-design planning and continuing through close coordination post-decision. It explores how consistent processes and cross-functional collaboration help ensure the timely, compliant disclosure of clinical data while safeguarding participant privacy and proprietary information, and how the applicant/marketing authorisation holder (MAH) can streamline operations, reduce compliance risks and reinforce public trust. Insights into common challenges and best practices for effective cross-functional collaboration are also shared.