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Compliance In Focus


Newest Post

Posted by John Lehmann on Fri, Jun 03, 2016

3 Myths Research Participants Are at Risk of Believing

MYTH 1: My doctor wouldn’t have told me about the clinical trial if he/she didn’t think it was in my best interest

Topics: Patients, Myths, Clinical Research

Posted by John Lehmann on Wed, Mar 04, 2015

Does a Lack of Device Labeling Standard put Patients at Risk?

Recently an announcement of a Public Workshop was posted on Federal Register (FR). This workshop, “Accessible Medical Device Labeling in a Standard Content and Format,” is to investigate the growing need for medical devices to be labeled in a clear and concise manner. Currently, there is a lack of direct regulation that defines a standard for medical device labeling. FDA hopes this workshop will begin the process of establishing a standard.

Topics: Patients, Federal Register, Device Labeling, FDA

Posted by Sandra Maddock on Wed, Mar 04, 2015

Should Patients Have Access to Data From Their Device?

This question was recently raised by an article published in the Wall Street Journal and a blog published on ieee spectrum. Currently patients cannot have access to the information without going through their healthcare provider. Should industry support patient access to all information pertaining to their medical device?

Topics: Patients, Access to Data, FDA, HIPAA

Posted by John Lehmann on Wed, Mar 04, 2015

A Quest to Modernize Clinical Trials

“More efficient clinical trials translate to reduced barriers to market for safe, innovative medicines, which is the ultimate goal of patients and manufacturers alike”- this statement from a recent article posted on BIO’s website speaks the truth. This is what we’re all after, but the question remains; how do we get there?

Topics: Modernize Clinical Trials, The Biotechnology Industry Organization, Patients

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.