QTPP

September 2, 2021

Planning, Preparing and Crafting the Drug Development Report

DSI has seen a lot of pharmaceutical development reports ranging from several hundred pages to a summary of conclusions attached to stacks of data. The latter can make things difficult when it’s time to put a regulatory filing together. It’s become clear that capturing development decisions and data from the outset in a living document is good practice and whether the data collected thus far is supporting development goals. It’s a reference point for what has been completed and what still has to be done.