Topic:

Clinical IT

Latest Headlines

Latest Headlines

EMA criticized for flip-flopping on clinical trial data transparency

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, Boehringer extend access to clinical trial data

Bayer and Boehringer Ingelheim outlined plans to increase access to their clinical trial data.

DrugDev buys TrialNetworks to 'glue' its clinical trial apps together

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.

FDA setting up data, informatics center with UCSF and Stanford

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.

Medidata unveils Sanofi deal as it looks to recover from rocky April

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.

BlackBerry plans healthcare-focused smartphone after making eClinical investment

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.

NCI plans database of patients who experience miraculous recoveries

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."

Pharma continues to grapple with trial participants' use of social media

While it is years now since clinical trial participants started talking about their experiences online, the industry is still searching for the best way to approach the phenomenon. And with pharma needing to improve the clinical trial process, the onus is on the industry to find systems that not only manage the negative implications of social media, but tap into its power, too.

Big Pharma companies open up cancer trial comparator arm data

A lot has changed in clinical trial transparency since Project Data Sphere outlined plans to share cancer results in 2012, with the European law voted in last week then still a distant threat. Even so, Pfizer, Sanofi and the other groups behind the initiative think it still offers something different now that it has belatedly launched.

Europe to create public clinical trial results database after passing law

The European campaign for greater clinical trial data transparency faced a big test this week when the region's politicians voted on legislation. More than 95% voted in favor of the regulations, paving the way for the creation of a publicly-accessible database of clinical trial results.