Clinical Research Investigator Sites Still Shrinking?

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...

FDA Released Two New Guidance Documents

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...

Senators Look to Spur Innovation & Get Products to Market Faster

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...

QbD Model for Clinical Trials Could Cut Costs

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...