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HEADLINE NEWS
Kendle upgrades global data platform
10 March 2010
Kendle International Inc has installed a new centralised data infrastructure that it says will help improve the access and the delivery of clinical trials data for its global customers. The new system, based on the industry-standard SAS software platform, allows Kendle’s network of biostatistics ...
PPD launches global biostatistics technology infrastructure...
Quintiles adds tissue testing to China services...
WuXi boosted by Chinese strength
09 March 2010
Building on "a strong fourth quarter and a successful 2009", the Shanghai-based pharmaceutical services provider and CRO, WuXi PharmaTech, said that in 2010, it expected to continued to benefit from double-digit growth in demand from customers in China, which should help offset relative weakness in ...
Quintiles extends its London research capabilities
08 March 2010
Quintiles has boosted its ability to handle Phase I trials and translational medicine initiatives with the opening of an extensionto its central London facility. Located on the 14th floor of London's Guy's Hospital, the expansion adds 35 additional beds to the company's existing Phase I capacity, ...
Application services save Medidata's 2009 revenues
05 March 2010
Medidata Solutions, a global provider of hosted clinical development solutions, today announced a net revenue increase of 20% and 33% in the fourth quarter and full year 2009, respectively, with net income increasing to $1.7 million in the fourth quarter and $5.2 million in the full year. Net ...
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NEWS
FDA issues draft guidance on adaptive trial protocols
10 March 2010
The US FDA has issued draft guidance on adaptive trial designs which encourages sponsors to have early meetings with agencies. The guidance "discusses clinical, statistical, and regulatory aspects of a wide range of adaptive design clinical studies that can be proposed as part of a drug development ...
Kendle upgrades global data platform
10 March 2010
Kendle International Inc has installed a new centralised data infrastructure that it says will help improve the access and the delivery of clinical trials data for its global customers. The new system, based on the industry-standard SAS software platform, allows Kendle’s network of biostatistics ...
PharmaNet recruits children for hayfever drug trial
09 March 2010
PharmaNet Development Group Inc is looking for children to take part in a new Phase I/II trial of the Spanish pharmaceutical company Faes Farma ’s hayfever drug, Bilastine, a novel antihistamine. The company is looking for 44 patients between the ages of two and twelve with either allergic ...
PharmaNet to host drug development symposia in three cities
09 March 2010
PharmaNet Development Group is to host a series of symposia and round-table discussions in three cities in the US on "Accelerating Early Stage Development and the FDA's Critical Path Initiative". The first two symposia will be in California, in San Francisco on the 16 March and on the following day ...
Almac honoured for contribution to Northern Irish business
09 March 2010
Almac Group, a contract development and manufacturing organisation based in Craigavon, Northern Ireland, has won an award for its "outstanding contribution to the Northern Irish economy and improving business relationships between the UK and Ireland". The annual Aer Lingus Viscount Award for ...
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FEATURES
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 ...
Understanding the Chinese market...
The search for novel endpoints...
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 – ...
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PEOPLE
ACM appoints Asia Pacific manager
ACM Global Central Laboratory has appointed a new general manager of Asia Pacific, Nandan Rao , who will spearhead the company's growth in India and Southeast Asia. His first responsibility will be to oversee trials conducted by ACM's partner laboratory, before building the company’s own local ...
Venn Life Sciences hires new VP of business development
Venn Life Sciences has hired Dale Trask as vice-president of global business development. Mr Trask brings extensive experience in CRO business development and will be responsible for enhancing Venn's business partnerships, strategic relationships and growth into new markets. Mr Trask joins Venn ...
Entest Biomedical adds CRO experience to scientific board
Entest BioMedical has appointed Dr Vladimir Bogin to its scientific advisory board (SAB). Dr Bogin is the CEO of CRO Cromos Pharma. The company feels the addition of Dr Bogin to the SAB will "greatly assist in developing its clinical protocols as it moves forward to conducting both preclinical and ...
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COMMENTARY
Renal Failure: challenges and opportunities
The term renal failure describes a decline in the excretory function of the kidney due to a reduction in glomerular filtration rate. In adults, renal failure may be either acute, lasting from a few days to a few weeks, or chronic, lasting months to years. Acute renal failure is a medical ...
Filling the gaps
Most stakeholders in Europe are in favour of some form of EU centralised approval system for multinational clinical trials, with the pharmaceutical industry and the European Medicines Agency among the strongest backers for such a move. But the support is not unanimous: many national regulatory ...
The fight against malaria - all still to play for
If you didn't know, how many cases of malaria would you guess occur every year around the globe? A million? Two million? In fact, around 250 million cases of malaria occur each year. Most of these occur in developing countries, although malaria is also an issue for travellers from developed ...
UK wants harmonisation, not centralisation, of European trial approvals
The UK drug regulator, the MHRA, says it does not want a centralised approvals system for clinical trials in Europe, preferring instead the voluntary harmonisation project for authorising multinational studies that is currently being piloted in the EU. The MHRA also feels that introducing a single ...
EU promises multinational CTA harmonisation at last
The problem stems mainly from the way that the EU clinical trials Directive (2001/20/EC) has been implemented by the various member states. National authorities have different format, language and content requirements for clinical trial approvals, as well as different timelines for reviewing ...
Search continues for improved BPH treatments
The recent announcement by Boehringer Ingelheim that it plans to make the alpha blocker tamsulosin available without a prescription in the UK is a reflection of the continued interest in the benign prostatic hyperplasia (BPH) market. The condition affects some 15 million men across the seven major ...
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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
