Blog
New Draft Guidance on Maximal Usage Trials for OTC Drugs
On May 22, 2018, the US Food and Drug Administration (FDA) issued draft guidance for drug makers on maximal usage trials for the purpose of adding a topical active ingredient to an over-the-counter (OTC) drug monograph. A maximal usage trial is a...
Gretchen Parker to be published in the Fall 2018 AMWA Journal
Gretchen Parker, IRB Co-Chair and advisor at IRB will have her article, “A Medical Writer’s Guide for Applications to Institutional Review Boards” published in the Fall 2018 Issue of the AMWA Journal. The AMWA Journalis a nationally circulated,...
Current clinical research model is at risk due to the slow recruitment process
According to industry experts, the current research model is failing many people, but more specifically those who live in a mobile world. As of now, clinical trials take years to recruit. For example, oncology trials are only able to recruit half a patient...
Clinical Trial Industry will be transformed by a new emphasis on patients and data
Three factors could vastly transform the clinical research industry as we know it. The three factors include: the patient engagement movement, rich data and analytics, and the learning health system model, reported CenterWatch.1 Ken Getz, an industry...
MAGI’s Clinical Research Conference will feature Patti Connolly
Patti Connolly, Director of Clinical Services at Pearl Pathways, is a featured speaker at MAGI's Clinical Research Conference - 2018 East. MAGI is an organization that aims to streamline clinical research by standardizing best practices for...