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...
An interesting article by Zachary Brennan on outsourcing-pharma.com highlights the current status in the adoption of quality by design (QbD) methods for clinical research. According to the results of a survey presented at this year’s Avoca Quality Consortium Summit,...
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...
A new report from PricewaterhouseCoopers (PwC) found that the use of a risk-based algorithm to monitor clinical studies reduced the deployment of research associates and targeted more high-risk patients and sites. Although CROs and sponsors have been hesitant to use...
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...
A recent post from MedPage Today describes the newly published FDA draft guidance entitled “Enrichment Strategies for Clinical Trials to Support Approval of Human Drugs and Biological Products” that will potentially improve the speed of drug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...
