EMA clinical data publication policy comes into force
On 1 January 2015 the new EMA policy on publication of clinical data entered into force. Under this policy, the Agency proactively publishes the clinical reports submitted as part of...
View ArticleUS Institute of Medicine backs clinical data transparency
The US Institute of Medicine has published its report into transparency around clinical trial data. Somewhat behind policy developments in Europe on this topic, the US body first announced its...
View ArticleReport highlights rising levels of investigator turnover & protocol...
Global clinical trial performance and efficiency are hampered by high turnover and noncompliance among principal investigators and wide variation in investigative site experience, according to a...
View ArticleClinipace set for new wave of CRO M&A activity
Clinipace Worldwide has put in place a $50 million ‘war chest’ in a round of debt and equity financing to capitalize on a pipeline of corporate acquisitions. The company has announced that it plans to...
View ArticleEMA launches consultation on transparency & Clinical Trials Regulation
The European Medicines Agency has announced a public consultation on how its new transparency rules should be applied to the clinical trial database specified in the 2014 EU Clinical Trial Regulation....
View ArticleCHMP recommends medicines be suspended after CRO inspection
A number of medicines for which authorisation in the European Union (EU) was primarily based on clinical studies conducted at GVK Biosciences in Hyderabad, India should be suspended, says the European...
View ArticleFDA announces intended guidance topics for 2015
The FDA has published a list of new and draft guidance documents that it plans to publish during 2015. Several topics stand out among the 90 announced as potentially important for the clinical research...
View ArticleChugai to launch translational research division
Chugai Pharma has announced that it will establish a new division from April 1, specialising in early clinical development to accelerate the generation of proof-of-concept for in-house drug candidates....
View ArticleICON creates new innovation hub in Ireland
ICON plc has announced a new global innovation hub which will create 200 new jobs in Ireland. The hub will foster the development of new technologies and clinical trial processes that will enable...
View ArticleUS government outlines “Precision Medicine” plans
Building on President Obama’s announcement in his recent State of the Union Address, the US Administration has unveiled details about the Precision Medicine Initiative, a bold new research effort to...
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