Harald F. Stock, PhD, Chief Executive Officer of Grünenthal GmbH – the German pharmaceutical company that developed thalidomide in the late 1950s – recently offered a public apology to those who were harmed by the drug. The occasion for Dr. Stock’s address was the unveiling…

The next meeting of the University Industry Demonstration Partnership (UIDP) will be held in Lexington, Kentucky on October 17 – 19, 2012. These meetings are exceptionally useful for working through the philosophy of research partnerships.  Universities benefit from exploring new opportunities to expand research and…

Today’s Federal Register announces the permanent debarment by FDA of two individuals who worked for the Lee Research Institute in Lenexa, KS, in response to felony convictions arising from clinical trial misconduct. The site PI, Dr. Wayne Spencer, and Lisa Jean Sharp, Lead…

FDA and NIH could both face significant funding cuts if the executive branch is unable to reach an agreement with Congress on required spending cuts. At issue for FDA is the baseline taxpayer funding that must be in place before…

Excellent question.  As an electronic system, the InfoEd suite allows both PI’s and administrative staff to view in real time proposal and protocol information.  In the case of protocols, there are two general levels of access, one on the development…

Alternative models of IRB review have been a hot topic for well over a decade. Although local review remains the norm for most institutions, other mechanisms such as facilitated review are gaining momentum. In 1992, the US Office for Protection…

Two webinars were held in August 2012 to provide an overview and demonstration of various features that are available for board and program management in the Human Subjects, Lab Animals and Safety modules. The goal of the sessions was to…