Numerous pharmaceuticals are approved and marketed based on the premise that they favorably change disease state-biomarkers. However, recent data has shown that altering the biomarkers indicative of disease does not necessarily translate to ameliorated health. In an...
In November 2012, the FDA published a draft guidance, entitled “IRB Responsibilities for Reviewing the Qualifications of Investigators, Adequacy of Research Sites and the Determination of Whether an IND/IDE is Needed,” which outlines recommendations for the...
Today, the IEDC released the below press release: INDIANAPOLIS (Jan. 29, 2013) – Pearl IRB, LLC d/b/a Pearl Pathways, a life sciences product development and regulatory consultant company, announced plans today to expand its operations here, creating up to 38 new jobs...
One of the greatest challenges of clinical research is patient recruitment and retention according to Tufts Center for the Study of Drug Development (CSDD). To help clinical research professionals improve clinical trial management, Tufts CSDD analyzed more than 150...
The Tufts Center for the Study of Drug Development (CSDD) published its Outlook 2013 report on pharmaceutical trends. Although Tufts CSDD Director Kenneth I Kaitlin is optimistic about the future of dug innovation, he believes companies needs to identify and reduce...
