by Don McLean | May 9, 2019 | Blog
FREE DOWNLOAD: Lay Summary Whitepaper This complimentary lay summary whitepaper will explain: the ins and outs of lay summary writing, the importance of starting a pilot program, a checklist for lay reviewers, and strategic advice for becoming more transparent....
by Don McLean | Mar 14, 2019 | Blog
PhUSE: Retrospective vs. Proactive Anonymization of Narratives Exerpt from whitepaper originally published by PhUSE on March 14, 2019 by project co-leads – Rashmi Dodia, MS, RAC and Gregory Campbell, BS Executive Summary Ever since policy 0070 was first introduced in...
by Don McLean | Nov 8, 2018 | Blog
Why Lay Summaries Matter and Their Future by Staff writer Plain language summaries, commonly known as lay summaries, have become increasingly important for pharmaceutical companies in recent years. However, there are many sponsors that have yet to start their pilot...
by Don McLean | Sep 6, 2018 | Blog
Navigating the four types of clinical study reports by Staff writer 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...
by Don McLean | Aug 2, 2018 | Blog
Ask the expert: Policy 0070 redaction packages suspended by EMA until 2019 by Staff writer 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...
