In November 2012, the FDA published a draft guidance, entitled “IRB Responsibilities for Reviewing the Qualifications of Investigators, Adequacy of Research Sites and the Determination of Whether an IND/IDE is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 Annals of Internal Medicine published a guideline, entitled “The Standard Protocol Items: Recommendations for Interventional Trials” or SPIRIT 2013 to address the clinical practice quality issues surrounding current trials, as reported by an article on...
A recent article from mobihealthnews.com describes how technology is helping streamline clinical trials by bridging communication between investigators, pharmaceutical companies and participants. Communication between companies and third party investigators is often a...
A recent post from MedPage Today describes the newly published FDA draft guidance entitled “Enrichment Strategies for Clinical Trials to Support Approval of Human Drugs and Biological Products” that will potentially improve the speed of drug development. The guidance...
