Preparing Your Investigational New Drug Application or New Drug Application
Monogram Biosciences can provide its clients with validated cumulative data in the form of an electronic data deliverable (EDD) in support of New Drug Application (NDA) and other regulatory submissions. With advance notice, clients can customize the contents and format of the demographics and the scientific data within the EDD to meet their individual needs. EDDs are available in both text and Microsoft® EXCEL® format and can be delivered at multiple time points during and after the study per the client’s needs.
Monogram scientists will also write a results report to help with an NDA filing. Additionally, Monogram’s Clinical Research team is available for consultation for clients designing clinical trials.