Start Early: Begin the clinical overview preparation early in the drug development process to allow ample time for data compilation, analysis, and review.
Pre-Submission Meeting: Collaborate with regulatory colleagues and consider requesting a pre-submission meeting between the regulatory authority and the core subject matter experts (SMEs) from safety, medical, clinical, pharmacology, statistics, and epidemiology to discuss the content, format, and any potential concerns, based on initial data analyses, regarding the clinical overview as well as timelines for submission.
Meet Regularly: Schedule a kick-off meeting and a regular series of meetings for the team to stay connected and aligned on timelines for authoring, review cycles, the flow of content and style, awareness of dependencies, or any potential delays that can be communicated in real-time.
Plan Well: Draft realistic timelines, factor in buffer time, and identify rate-limiting bottlenecks that may arise during Clinical Overview development and require truncating of timelines. Identify the sequence of development of the various CTD components calling out interdependencies. Explore the best approach feasible to work smart - the possibility of adopting a follow-the-sun model to make the best possible use of time. Align the writing team with the creation of a document shell/outline with clear instructions so that the resultant Clinical Overview contains the right amount of well-organized data adhering to the 30-page limit recommendation per regulatory guidelines. Write different sections as and when data becomes available, and do rolling reviews to save reviewer time and catch any needed changes early. Plan review slots for all reviewers, especially when the same team is working on multiple documents.
TEAM Work Prevails: Engage experts from various disciplines, such as safety, clinicians, statisticians, pharmacologists, and regulatory affairs professionals, to ensure comprehensive and accurate content. Engage with the regulatory affairs team to ensure the Clinical Overview meets regulatory expectations and standards.