The controversy surrounding the European Medicines Agency's trial data transparency draft terms put this week's management board meeting in the spotlight, with campaigners hoping the regulator would rethink its policy. And to an extent, the EMA did, but the compromise it proposed is unlikely to fully satisfy either side of the debate.
Cambridge Cognition has introduced two iPad-based products for use in clinical trials.
The potential cost savings generated by risk-based monitoring of clinical trials has led some to tip it as a way to significantly streamline pharma's flabby studies. And that potential has lured tech providers, with Medidata and Parexel both advancing their claims on the market this week.
When European politicians voted overwhelmingly in favor of a clinical research data sharing law last month, it looked like a big step forward for transparency campaigners. Yet just weeks later researchers have raised concerns that the European Medicines Agency is already trying to lessen the impact of the legislation.
Bayer and Boehringer Ingelheim outlined plans to increase access to their clinical trial data.
Trial investigator network DrugDev bought CFS Clinical in October to expand its offerings. Eight months later DrugDev has made its second deal, with the focus shifting to adding the "technological glue" that will tie its acquired tools together.
The FDA is setting up its first West Coast Center of Excellence in Regulatory Science and Innovation (CERSI) to further strengthen ties with academia and improve its use of informatics and data-driven computer models. The University of California, San Francisco, is housing the CERSI, which it will run in collaboration with scientists at Stanford University.
Having already been hit by the March selloff of biotech and tech shares, Medidata's stock sunk lower still last week after first-quarter results disappointed Wall Street. This week the eClinical provider had better news, with Sanofi signing up to use its risk-based monitoring technology.
John Chen has begun refocusing BlackBerry on healthcare and other industries with specialized requirements. And evidence of just how deep BlackBerry plans to get into healthcare emerged this week when the company outlined plans for a smartphone tailored to the industry.
Every clinical trial has its outliers. Some patients respond far better to the treatment than the rest, but the focus on efficacy across the study population means these results--and their implications--are lost in the shuffle. The National Cancer Institute is trying to change this by improving the tracking of data on these "exceptional responders."