EDC Adoption in Global TrialsWith the expansion of clinical research into emerging countries, many companies are pushing for global electronic data capture (EDC) adoption in an effort to improve the efficiency and accuracy of patient data collection methods. Although there are many advantages to converting to a paperless system, there are several new challenges that have arisen in the process. Limited IT, inadequate training in EDC technology and language barriers have all contributed to the relatively slow progress of EDC adoption in international clinical trials. 
LC provides translations and interpreters to BIO 2012
Are you attending the BIO International Convention 2012 in Boston this June? Come visit our booth #2711 and let us know if you need foreign language interpreters for your panel sessions. As an official language service provider to BIO 2012, we are proud to serve you as well. Contact us at translate@languageconnections.com or call us at 617-731-3510! We are looking forward to meeting you.
Learning to Speak IowanUntil recently, in many U.S. cities the primary focus has been on overcoming language and cultural barriers between American doctors and immigrant patient populations. With greater numbers of foreign doctors being encouraged to work in rural communities in the United States, however, new communication barriers have arisen. For one thing, there is a wide cultural gap between the foreign doctors and the rural communities that they serve. As a result, some rural hospitals are making it mandatory for foreign physicians to complete cultural adaptation training programs. We invite you to read our recent white paper entitled "Learning to Speak Iowan" which discusses these issues, including specific examples which have recently made headlines. 
Indian Generics Dominate US Market
Glenmark Pharmaceuticals, an Indian generics company, recently launched its malaria treatment drug in the US. Glenmark's anti-malarial atovaquone and proguanil hydrochloride tablets are the generic equivalent of GlaxoSmithKline's brand Malarone. The Indian pharmaceutical company settled a patent litigation with GlaxoSmithKline in April 2010, which allows Glenmark to launch the generic tablets in the US in 2011.
With Pfizer's cholesterol-lowering blockbuster Lipitor going off patent on December 1, another Indian generics company, Ranxbury, is hoping to corner that market with their generics version of Lipitor (currently the largest-selling drug in the world). Ranxbury has put a tremendous effort, as well as investment, into preparing their generic version of the drug. However, Pfizer may not let it go so easily. Since 2008, Ranxbury and Pfizer have been involved in patent litigation procedures which delayed the release of a Lipitor generic through November 30 of this year. During this time the rules to the game have changed. Last year Pfiizer sold rights for Lipitor to Watson Pharma (a New Jersey-based company) allowing it to sell the generic version of the drug, as long as 70% of drug revenues go to Pfizer over the next five years.
Ranbaxy was given first rights on selling a generics version of Lipitor in 2002 because it was the first to apply for FDA approval. In 2008, the two companies reached an agreement that the generic would be released on November 30, 2011. However, whether the FDA would grant approval, given the manufacturing problems that the agency reported at Ranxbury (the FDA accused a Ranbaxy plant in India of submitting false and unreliable data) remained unclear. As a result, in 2009 the FDA invoked an 'application integrity policy' against Ranbaxy, which placed its drug applications under greater scrutiny and required certain corrective actions. In the meantime, Pfizer made an agreement with Watson Pharmaceuticals. The issue is yet to be completely resolved.
Indian generics dominating the market, however, is not news if we look at the US generics market today. In fact, as of this year, Indian companies account for 35 % of all abbreviated new drug application approvals in the United States. Despite isolated problems associated with one of India's largest generics producers mentioned above, i.e. Ranxbury, other top Indian generics companies in the US market are either maintaining or improving their approval rates this year. Along with Glenmark, two other companies, Aurobindo and Sun Pharma, have risen to the number one position as leading generics-selling companies in the US in just the last few years. This trend is likely to continue with the opening of FDA offices in New Delhi and Mumbai this year. However, US and other multinational pharmaceutical companies are preparing to fight back, and, like Pfizer, are joining the major players in the generics market. The race has begun, will there be a tie?
References
http://www.fiercepharma.com/story/indian-drugmakers-push-us-market/2009-03-06 http://www.business-standard.com/india/news/indian-pharma-remains-top-in-us-generics/420523/ http://articles.economictimes.indiatimes.com/2011-11-30/news/30458695_1_generic-version-arun-sawhney-ranbaxy-laboratories 
LC Lectures on Cultural Adaptation in Clinical Trials
Language Connections was recently invited to participate in teaching part of an online course, "Principles of Transcultural Health Care", as part of a master's degree program at the University of Medicine & Dentistry of New Jersey geared toward biomedical professionals.
The session presented by our life science expert, entitled 'Cultural Adaptation in Clinical Trials', primarily dealt with the logistics of overcoming linguistic and cultural barriers among increasingly diverse patient populations participating in clinical trials. The lecture provided a forum for the discussion of linguistic and cultural issues related to minority under-representation in US clinical trials as well as barriers to informed consent, data accuracy, and other challenges related to outsourcing international clinical trials.
In addition, the session provided a review of current industry trends in outsourcing, as well as a summary of major challenges in clinical research which must be addressed to ensure the quality of clinical research despite significant linguistic and cultural differences. Although the primary focus of the lecture was on the importance of cultural adaptation, the issue of language as it relates to translation, as well as socio-economic disparities among patients participating in clinical studies were also discussed. Bienvenidos a Language ConnectionsLanguage Connections es una compañía proveedora de servicios lingüísticos, cuyo enfoque es ofrecer traducciones y servicios de interpretación de alta calidad a clientes que se encuentran en los Estados Unidos y en todo el mundo. Puede apoyarse en nosotros para traducir cualquier material especializado y de distribución mundial en el área legal, técnica, médica y de marketing. A su vez, podemos brindarle intérpretes y equipos para conferencias internacionales y reuniones de capacitación. Language Connections trabaja en más de 100 idiomas. Nuestros traductores e intérpretes han sido cuidadosamente seleccionados. Se enfocan en áreas altamente especializadas, tal como la industria farmacéutica, asistencia médica, derecho, marketing, biotecnología y otras ciencias avanzadas. Nuestros clientes confían en nosotros porque entendemos que se requiere de expertos en la materia para trabajar en sus proyectos altamente técnicos. Nuestro riguroso control de calidad y soluciones personalizadas le garantiza que recibirá los mejores servicios lingüísticos. No hay margen de error en su trabajo. Nos aseguramos que tampoco encuentre en el nuestro. ¡Bienvenidos a su portal lingüístico! Por favor contáctenos para discutir sus proyectos: Esta dirección electrónica esta protegida contra spambots. Es necesario activar Javascript para visualizarla . Llamada gratuita desde Estados Unidos: 877-731-6332 . |
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