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HEADLINE NEWS
HHS awards $17 million for patient-centred outcomes research
03 September 2010
The US Department of Health and Human Services (HHS) will award three grants and cooperative agreements totalling nearly $17 million, for patient-centred outcomes research (PCOR), or research that compares treatments and strategies to improve health outcomes for patients. The three-year funds, made ...
NIH expands US research network...
Collaboration formed to better match trial patients through ...
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 ...
Study finds sponsors could do more to support patient recruitment
01 September 2010
Are sponsors doing enough to support their patient recruitment and can outsourcing to a CRO or other external vendor significantly help the process? And when does a sponsor begin to consider using a CRO to help with their patient recruitment? Collecting data from 39 sponsors, 27 CROs and 18 patient ...
Exco InTouch snaps up GSK patient recruitment head for global role
01 September 2010
Mobile technology provider Exco InTouch has named ex- GlaxoSmithKline (GSK) patient recruitment head Judith Teall as its director of patient recruitment to build its in-house expertise in the challenges of patient recruitment to find new places for its technology services on a global basis. "We ...
>> More Headline News...
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, ...
HHS awards $17 million for patient-centred outcomes research
03 September 2010
The US Department of Health and Human Services (HHS) will award three grants and cooperative agreements totalling nearly $17 million, for patient-centred outcomes research (PCOR), or research that compares treatments and strategies to improve health outcomes for patients. The three-year funds, made ...
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 ...
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FEATURES
Strategies for successful FDA-approved labelling with patient reported outcomes
13 August 2010
Any report of the status of a patient's health condition that comes directly from the patient, without interpretation of the patient's response by a clinician or anyone else, is a patient-reported outcome (PRO). A PRO instrument is a measuring scale or questionnaire that serves as a means to ...
Fail-proof preparation for audit success...
GPP versus GCP: design, conduct, implementation and interpre...
Conquering cancer in the developing world; the INDOX approach
21 July 2010
The clinical trials sector in India is growing dramatically and could top $2 billion by 2012. In parallel, the rate of cancer in India is increasing due to ongoing lifestyle changes. Joanne Payne profiles a unique academic oncology network that is working to combat what is often thought of as a ...
Emerging markets and the need for training
16 July 2010
The opportunities for CROs and pharma companies in the emerging markets of China,India, the Middle East and Africa are vast and encompass all phases of clinical research. However, international training of clinical research personnel in the industry is urgently needed to cope with the increased ...
Migrating from the middle; finding a space for the niche CRO
16 July 2010
Bigger is not always best, but this certainly seems the case for CROs, as competition increases to supply services to a shrinking number of large pharma companies. Nevertheless, focusing on a single therapeutic niche may be a good business strategy for firms unable to effectively compete and ...
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PEOPLE
Advanced Clinical names new VP
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
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
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 ...
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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 ...
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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
