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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 ...
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 ...
Reflection and recommendation; foreign trial data under scrutiny
08 July 2010
The integrity of clinical trial data is never far from the spotlight these days, with companies and regulators coming under increasing pressure to be more transparent in how they report and publish trial results. Now attention is increasingly turning to the global stage. As the number of clinical ...
Rare diseases in the Middle East: prospects for CROs
02 July 2010
The treatment of rare diseases in Europe has been significantly enhanced by the EU’s Orphan Drug Regulation and by the raised levels of public awareness, improved by the activities of interest groups, with regard to existence and prevalence of such diseases. As a result, research into drugs aimed ...
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 managingdirector of Synexus South Africa and AddClin Research . Her clinical 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 ...
The Chinese climate for clinical trials
21 June 2010
China is the world’s second-largest economy and has a pharmaceutical industry that has grown by approximately 22% annually over the past five years. Industry analysts predict that in 2010, the total value of the global pharmaceutical market will grow by 4-6%, to more than $825 billion. China, at ...
Diabetes sector continues to generate immense interest
17 June 2010
Looking at a list of companies carrying out clinical development of new products for treating diabetes is like reading a Who’s Who of the pharmaceutical industry. According to Citeline Drug Intelligence , a total of 116 companies are developing products for the treatment of type 1 or type 2 ...
The quest to find new treatments for anxiety disorders
27 May 2010
Anxiety disorders are relatively widespread, yet no new anxiolytic product has been launched for a number of years. Dr Peter Charlish reports on this group of disorders, which includes obsessive-compulsive disorder and post-traumatic stress disorder, and investigates anti-anxiety products ...
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 ...
Optimising country selection: the strategic importance of a feasibility database
26 May 2010
One of the chief challenges for clinical trials is the development of an optimal country distribution plan, Kendle ’s Chantal Demblon and Louise Bissett-Bryson explore the best strategies. To assess the appropriate countries for a specific protocol or study design on a daily basis is easy to do ...
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 ...
Supersizing: is it time to go large?
25 May 2010
Merger and acquisition activity, both in terms of pharmaceutical and outsourced supplier companies, has dominated the trade press headlines for the past 12 months. ClinTec International’s president and founder Dr Rabinder Buttar discusses what the super-sized pharmaceutical sponsor could mean for ...
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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
