by Prakash Achaary | Sep 6, 2018 | Blog
A Clinical Study Reports (CSRs) are critical documents that describe the methodology and results of a clinical trial in drug development. As of late, CSRs have been reviewed under a higher level of scrutiny as the U.S. Food & Drug Administration (FDA) announced a...
by Prakash Achaary | Aug 2, 2018 | Blog
Last week, the European Medicines Agency announced that as of August 2018, it would “temporarily scale back or suspend additional activities until at least September 2019.” This means that redaction proposal packages submitted until the end of July 2018 will continue...
