For individual studies EDETEK will provide support in selecting what data to collect and how it should be structured. Clinical databases can be configured to be industry compliant from the start eliminating most of the need for later standardization. Legacy and non-compliant ongoing studies can be mapped and integrated with other studies which increase insight into product safety and efficacy.
EDETEK’s process for data conversion utilizing our data standardization platform is cost effective and timely eliminating the need to wait for an impending regulatory filing to initiate. The insight that can be obtained for looking at standardized, integrated data throughout the development process rather than only at the end can often save millions of dollars in failed or unnecessary studies. Of course, if you’ve waited until the last minute to prepare for an Agency Safety Update Report or NDA Filing, we can accommodate those needs as well. Let’s discuss how easy it can be!