Last month at Partnerships in Clinical Trials (PCT) in Barcelona, Spain, TransCelerate Biopharma CEO, Dalvir Gill explained to contract research and pharma industry representatives that working together to fix issues is the key to simplifying and expediting the...
Clinical trial sponsors and contract research organizations (CRO) are working together to find a balance between the level of micromanagement and the quality of trials. Outsourcing-Pharma.com’s Zachary Brennan reports that recent studies found that only 41% of...
IMARC Research, a contract research organization (CRO) recently published a list of the “Top Five FDA Warning Letter Findings for Clinical Investigators.” Warning letters are issued when FDA finds objectionable conditions upon inspection. IMARC’s top 5 noted...
In November 2012, the FDA published a draft guidance, entitled “IRB Responsibilities for Reviewing the Qualifications of Investigators, Adequacy of Research Sites and the Determination of Whether an IND/IDE is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...