The current worldwide economic downturn is continuing to shrink the number of investigative sites across the globe. The sharpest decline in investigator sites has occurred in Europe according to CenterWatch. The US is not immune to this activity as the most active...
All of us in research are aware of the challenges with length and understandability of informed consent documents. In a new article found in the December issue of Anesthesiology News entitled “Uninformed Consent: Average Study Participant Likely Unaware of...
The FDA released two new documents aimed to clarify the process for clinical trial approval and establishing earlier clinical trial studies during device development. The FDA is currently searching for a small number of companies to in the pilot program. Jeffery...
A group of bipartisan senators introduced a plan to streamline the FDA’s regulation that would speed up the process of taking innovations to the market and encourage innovation. The bill would also focus on restoring balance to the conflict of interest...
The FDA is working on developing a quality-by-design (QbD) model for clinical trials that would cut monitoring costs. The plan is to implement the model within the next 25 years. There is already a QbD model is place for manufacturing that allows for the quality...