Overview
One of the key challenges facing any global pharmaceutical company is keeping up with and adapting to the amount of change and variation in regulatory requirements around the world. The Study Start-Up application provides an automatic way to generate the right list of documents required for a local site anywhere in the world. It also features a process to manage change to those rules easily as necessary, via business rules that drive the essential document lists from a business-friendly user experience.
Clinical studies are a precursor to clinical trials and ultimately, new drug introductions. While the volume of on-going studies is relatively low, they span long periods of time, involve numerous documents and participants, and span multiple locations in many countries. Study Start-Up achieves study site initiation readiness accurately and more quickly than ever before, by increased process visibility, speed to start-up and accurate country-level documentation - which were all former pain points, with clinical studies.
Key Features & Functionality
(Previously listed as Clinical Study Management)