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LATEST NEWS
CRF Health completes vendor certification programme for EXACT
03 September 2010
CRF Health , a provider of electronic patient reported outcomes (ePRO) solutions, has completed the ePRO vendor certification programme for use of the EXAcerbations of Chronic Pulmonary Disease Tool (EXACT). The EXACT is a PRO measure designed to standardise the method for evaluating the frequency, ...
Parexel launches new technology platform...
John Hopkins establishes US academic research network...
Quintiles to support European release of cystic fibrosis drug
02 September 2010
Quintiles has signed a strategic agreement with the biopharmaceutical firm Pharmaxis Ltd to support the European launch of its cystic fibrosis treatment Bronchitol. Under the agreement, Quintiles will execute what it called "a comprehensive commercialisation effort for Bronchitol across Western ...
PHT retains ISO 9001:2008 certification
02 September 2010
After an annual audit of its quality management system, the ePRO (electronic patient reported outcomes) specialist PHT Corp reported that it has retained its ISO 9001:2008 certification. The company first achieved ISO 9001:2000 certification eight years ago and was upgraded to ISO 9001:2008 ...
Datatrak achieves EU and Swiss safe harbour certification
01 September 2010
The eClinical firm Datatrak is now compliant with the US-EU and US-Swiss Safe Harbour Frameworks. Meeting these requirements reassures European customers that the Cleveland, Ohio-based company complies with all relevant European privacy and data protection laws, and ensures continued data flow in ...
>> More Latest News...
FEATURES
Shareholder mutiny may call time on Charles River's Chinese dream
25 June 2010
With three of the largest shareholders of Charles River Laboratories Inc (CRL) speaking out against the company's proposed acquisition of China's largest CRO, WuXi PharmaTech Inc , more than 17% of the company's investors have now made public statements against the merger and the research animal ...
EndPoint: Dr Sanet Aspinall
24 June 2010
Dr Sanet Aspinall is managing director of Synexus South Africa and AddClin Research . Herclinical trials experience includes 17 years in academia and research management and 10 years in the private clinical research industry where she has advanced expertise in the execution of both early and late ...
EndPoint: Alistair McDonald
27 May 2010
Alistair Macdonald , executive vice-president of strategic development at INC Research has 17 years experience in the pharmaceutical industry and has held senior management positions in manufacturing, consultancy, data management, and clinical operations. With INC Research, he has been responsible ...
Funding the Future
26 May 2010
Medidata Solutions’ co-founder and president Glen de Vries talks to Joanne Payne about running a business by predicting industry needs for ten years in the future, and the excitement of taking the company through an IPO during the most challenging economic climate in history It would be fair to ...
>> More Features...
PEOPLE
Advanced Clinical names new VP
03 September 2010
CRO Advanced Clinical , has named Julie Heneghan as vice-president. Heneghan has been in the outsourcing and staffing solutions industry for more than 20 years. As vice-president, she will be responsible for overseeing the strategic planning and direction of the US Midwest and Eastern division and ...
Outcomes Health strengthens IT team
02 September 2010
Outcomes Health Information Solutions , a data abstraction and analytics company working with CROs and pharmaceceutical companies, has named David Jeans as the new vice-president of data management and chief enterprise architect. Jeans is responsible for leading the execution and enhancement of ...
Prism appoints Nigel Brooksby as non-exec chairman
02 September 2010
Drug development consultancy Prism Ideas , has appointed Nigel Brooksby , as non-executive chairman. Brooksby has more than 35 years experience in the life sciences industry, culminating in his position as chairman and managing director for Sanofi-Aventis UK and leading the UK's Association of the ...
>> More People...
COMMENTARY
MHRA Guidance; impacts for the central lab
Our quality assurance officer in Europe, Elizabeth Atkin , and I attended the MHRA conference – GCP for Clinical Laboratories – Clinical Pursuits in York, England, at the beginning of the year. The various sessions throughout the day provided comprehensive overviews of how the clinical trials ...
As Scott Reuben faces jail, just how common is fraud in clinical trials?
Last month, the prominent and pioneering anaesthesiologist Scott Reuben , chief of acute pain at Baystate Medical Centre , was sentenced to six months in prison for falsifying the data in, or entirely inventing, dozens of clinical trials. In the end, what caught Reuben was an audit of two papers ...
As wages increase, is China still a good location for clinical trials?
The recent condemnation by Charles River Laboratories ' largest shareholder of that company's proposed acquisition of the leading Chinese CRO, WuXi PharmaTech , raised questions about whether companies are being too optimistic about the potential of China as a location for clinical research and the ...
Publication bias on the agenda again
IQWiG , the German health technology assessment institute, has renewed its call for legislation to make the prospective registration of clinical trials mandatory and to compel trial sponsors to publish the full results of all trials in a results database. The demand comes in a new study, published ...
Decision time: how to take the EDCTP forward
A proverb attributed to the Chinese philosopher Lao Tsu says: give a man a fish and you feed him for a day; teach a man to fish and you feed him for a lifetime. That sentiment could well be applied today to the provision of medicines for diseases that predominantly affect resource-poor countries, ...
Challenges and breakthroughs in IBD
Inflammatory bowel disease is a term used to cover two specific conditions that are both chronic diseases that affect the gastrointestinal tract – Crohn's disease and ulcerative colitis. The main difference between them is the area of the gut that they affect. In Crohn's disease, the inflammation ...
>> More Commentary...
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EVENTS
Clinical trial supply Asia 2010
14 September 2010
Singapore
Children's Medicines Working Party
28 September 2010
London, UK
Drafting and negotiating clinical trials agreements
09 November 2010
London, UK
