Institutional review boards were established to protect the rights and welfare of human research subjects. Review and approval by an IRB are necessary before human subject research can begin. Last week, the US Food and Drug Administration (FDA) and the Department of...
On May 22, 2018, the US Food and Drug Administration (FDA) issued draft guidance for drug makers on maximal usage trials for the purpose of adding a topical active ingredient to an over-the-counter (OTC) drug monograph.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 pharmacokinetic (PK)...
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, peer-reviewed...
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 per site...
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 veteran spoke at...
