Raps.org journalist, Alexander Gaffney reported that an EU court has surprisingly issued an interim order that the European Medicines Agency (EMA) should stop publishing any more information or documents until a final order has been passed regarding public...
Researchers at the University of Tennessee Health Science center created a website to enhance recruitment during a multi-center trial to study women who suffer from vulvar pain. The website contained prescreening questions as well as informational videos targeted to...
The Council of the World Medical Association (WMA) released draft revisions to the Declaration of Helsinki (DoH) early in April, according to a recent article from outsourcing-pharma.com. The DoH was last revised in 2008 and establishes the ethical principles of...
The Office for Human Research Protections discovered that a study involving premature babies did not disclose potential risks of the associated treatment with the involved families as indicated by a recent article published April 11, 2013 in the New York Times. The...
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...
inVentiv Health Clinical recently invested in Mytrus, a California based “Virtual Trial” company. Mytrus has previously parted with Pfizer to create REMOTE, an “at home” clinical study of the bladder control drug, Detrol LA. Although the Pfizer study failed to meet...