If you are like most clinical teams and sponsors, you wonder what questions FDA and other regulators will ask when they review your submissions (e.g., protocols, SAPs, briefing documents, CSRs). We help demystify the process. Using our CDER biostatistical reviewer expertise, we do statistical reviews of your regulatory submissions and adeptly identify gaps in your regulatory submissions, identify inconsistencies and propose questions regulators may ask. You can use this information to strengthen your submissions and to prepare for regulatory interactions.
To help you meet internal timelines with the most efficient use of your resources, you would invite us to collaborate on your draft documents before you submit them to regulatory authorities. Early involvement allows us to help you write the best possible submissions and generate regulator feedback that is the most helpful to you. Potentially, you will save time for your development program by reducing the number of regulatory interactions.
Leading up to your regulatory interactions, we collaborate with your teams and help guide responses to these anticipated questions. We propose responses to written feedback from regulators. Teams find it helpful when our founder Lisa is a member of mock FDA meetings. She has attended countless industry meetings as an FDA team leader and reviewer, and as an industry statistician. As a result, we appreciate regulatory/industry meeting dynamics and use this experience to help you be prepared for your regulatory interactions.