A Guide on FDA Study Data Submission Requirements

A Guide on FDA Study Data Submission Requirements The Challenges in Complying with SEND The evolving guidance of the FDA on nonclinical dataset submissions requires organizations to adapt procedures to ensure full regulatory compliance. The Food and Drug Administration rejects as many as one in three study data submissions due to technical factors. Nonclinical studies […]

WHAT IS SENDIG v3.1.1 FROM CDISC?

What is a LIMS? A Laboratory Information Management System (LIMS) is a software solution designed to meet the needs of the modern laboratory. LIMS software facilitates the management of samples and…