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Pfizer, Peakdale and in-house outsourcing
19 February 2010
The recent news that the contract research services firm Peakdale Molecular Ltd is to take up home within Pfizer's main European research hub as part of a new on-site working agreement, presents an innovative new slant on pharma outsourcing and puts a new spin on the relationship between pharma ...
Strategies for periodic safety reporting: update on the new DSUR concept
04 February 2010
The submission of periodic reports to Regulatory Authorities (and ethics committees) is mandatory in many countries. In the USA for instance, an Investigational New Drug (IND) Annual Report detailing the safety profile of an investigational drug is submitted to the FDA on an annual basis. ...
EndPoint: Jeff Thomis
03 February 2010
Dr Jeff Thomis, PhD, is president of global clinical development services at Quintiles. He has worked at the CRO since 1997 but has held his current position, which involves selling and delivering services for Phase II-V studies, since 2006. Before Quintiles he spent 21 years at Bristol Myers ...
Where to next.
01 February 2010
If one were to rank everything spoken by everyone working for a CRO or drug company over the past ten years by frequency of use, the phrase ‘emerging market’ would be right near the top. But what does it actually mean? The term continues to be applied to a number of relatively established markets – ...
Playing data capture catch-up in Japan
22 January 2010
Over the last decade Japan, despite being the second largest drug market in the world and possessing a notable R&D ability, has lagged behind the US and Europe in bringing drugs to market. Japan’s Pharmaceutical and Medical Device Agency (PMDA) calculated in its 2007 annual report that it took 2.5 ...
Reviving the Japanese clinical trial system
21 January 2010
Japan is one of a few countries that developinnovative medicine for patients globally and as in other countries, such as America and China, Japan has some unique regulatory requirements for conducting its clinical trials. In 1996 the ICH-GCP standards were agreed across Japan, the US and the EU, ...
EndPoint: Janette Benaddi
21 January 2010
Janette Benaddi, chair of the Institute of Clinical Research Janette Benaddi has over 20 years experience of managing pre and post market clinical studies in both devices and pharmaceuticals. Prior to founding Medvance 12 years ago, she worked in Paris for a medical device consultancy group as a ...
Clinical Trials in the Republic of Kazakhstan
19 January 2010
Although the potential of Kazakhstan has only recently begun to be exploited, and the number of clinical studies currently underway is comparatively small, its significance as a player in this market is predicted to grow rapidly. Kazakhstan boasts a centralised healthcare system with a large ...
Making a case for the Middle East
19 January 2010
Rani Abrahams, associate director, Regulatory Affairs and Clinical Operations at ClinTec International During the past decade, spending on contract clinical services has been growing at an annual rate of 13.4%, with total spending in 2009 amounting to around £50 billion, according to figures in ...
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Designing the Future Conditions for Clinical Research in Europe
17 March 2010
Brussels, Belgium
ICR Annual Spring Conference and Exhibition
19 April 2010
London, UK
CDISC Interchange Europe
26 April 2010
London, UK
