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Compliance In Focus


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Posted by Stephani Hulec on Fri, Jul 20, 2018

FDA Shutdown - How Have Clinical Trials Been Affected?

In our recent blog , we discussed the backlog of clinical trial submissions the FDA now faces, which was caused by the temporary government shutdown.  The articles cited in that blog focused on the impact of new FDA submissions, and particularly on the detrimental effects to start-up companies.  However, how have ongoing clinical trials been affected during this time period?  More importantly, how have the lives of the patients on the other side of that experimental drug or device been affected?

Topics: Government Shutdown, National Institute of Health, FDA

Posted by Brandy Chittester on Wed, Mar 04, 2015

Healthy Control Volunteers - Using the FAIR Shake

According to the National Institute of Health (NIH), nearly 3,500 people participate in the Clinical Research Healthy Volunteer Program (CHVP). The program, started in 1954, provides an opportunity for healthy volunteers, locally, nationally, even internationally, to participate in medical research studies to provide researchers with important information for comparison with people who have specific illnesses.

Topics: National Institute of Health, Healthy Control Volunteers, The FAIR Shake

Clinical Research Training Requirements
Featured Resource

clinical research Training requirements

This whitepaper examines the similarities and differences between various US and international regulations and place them within the context of any number of roles found within the realm of clinical research.