In November 2012, the FDA published a draft guidance, entitled “IRB Responsibilities for Reviewing the Qualifications of Investigators, Adequacy of Research Sites and the Determination of Whether an IND/IDE is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...
According to an article on Outsourcing-Pharma.com, a new study indicates that the regulation of clinical trials in other regions of the world is too rigorous, urging pharma firms and CROs to create designs that are universal. The article entitled, “Trial regulation in...
According to an article on Outsourcing-Pharma.com, there is a dire need for strong, clear communication between entities when transferring IRB responsibilities. The article, entitled “Sponsor – CRO communication critical to IRB transfer; FDA,” states that all...
Check out what our friend and colleague Christine Pierre had to say in this February 21, 2012 article by Ann Neuer of bioitworld.com. Christine gave her thoughts on the current budget woes that exist within the clinical trial process. As she shares, budgets are...
As reported in Outsourcing Pharma, a new study conducted by the Tufts Center for the Study of Drug Development shows that CRAs (clinical research associates)spend less than half their time doing on-site monitoring tasks. This report included close to 4,000 CRAs from...
