Pharmarama To Offer Comparator Drug Sourcing Services For Clinical Trials In China

Main Category: Clinical Trials / Drug Trials
Article Date: 16 Nov 2007 - 2:00 PDT

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Pharmarama.com, a leader in the procurement of pharmaceutical products for comparator trials and named patient programs, announced at BIO-Europe 2007 in Hamburg, Germany, that the firm will be providing complete services to source comparator drugs for clinical trials in China. Pharmarama.com believes that it is the first global clinical trial supply company to have the necessary relationships and protocols in place to source comparator drugs both into and out of mainland China.

"China is set to be among the top 5 largest pharmaceutical markets in the world by 2010 and is becoming a major setting for clinical trials," said Angus Cameron, Pharmarama's Director of Business Development and spearhead of the company's China operations. "Holding clinical trials in China carries the benefit of reducing the time for a drug to reach the rapidly growing local market, and also presents a large patient pool important for worldwide drug development at a time when patient recruitment is becoming increasingly difficult."

However, procuring comparator drugs for clinical trials in China - an often-key component of the trial process - and the management of their associated logistics is a complex, time-consuming process. Given stringent local regulations and recent international concerns over the quality and safety of products manufactured in China, the comparator drug procurement process has become even more daunting.

"We are continuing to put in place the protocols to ensure compliance with the State Food and Drug Administration's (SFDA) new Drug Registration Regulation, in effect this October, and can provide our clients with a complete pedigree on any comparator drug sourced within China for their global trials," continued Cameron. "This will ensure trial sponsors and CROs of the total reliability of the comparator chosen, from the manufacturer through to the clinic. We also have the procedures and the relationships established to provide Chinese-licensed European comparators into the vast Chinese clinical trial market through both international multi-centre programmes, as well as in cooperation with the 251 major hospitals licensed by the SFDA to conduct clinical trials."

Clinical trials for pharmaceuticals in China are typically conducted through one or more of the 251 Chinese hospitals licensed by the SFDA. These hospitals, found throughout China, have been selected according to a set of specific criteria and are focused on various clinical specialities. Bringing European licensed drugs into China for a comparator trial is also possible as part of an international multi-centre programme, where the protocols have been agreed to by ethical committees overseas and the program initiators are also from overseas.

About Pharmarama

Pharmarama.com is a licensed wholesaler and importer of licensed and unlicensed medicines, based in London, England, with offices located in the United States and Germany. The company, in partnership with BR Pharma, provides validated comparator drug services such as sourcing, supply chain management and support services including drug warehousing, custom pharmaceutical manufacturing, packing and translation services.

Pharmarama.com was founded in 2006 by Ben Rabin as the U.S. affiliate of UK-based BR Pharma Limited, which first gained recognition for obtaining regulatory permission to import Ritalin SR into the U.K. Rabin, a pharmacist with over 40 years in the retail and wholesale pharmaceutical industries, and BR Pharma have provided over a decade of service to the world's leading pharmaceutical companies and clinical research organizations sourcing and procuring pharmaceutical products for clinical trials, as well as providing services for named patient programs. Pharmarama works in collaboration with BR Pharma as a single point of contact for the sourcing, repacking, blinding and distribution of comparator drugs worldwide.

http://www.pharmarama.com
http://www.brpharmaltd.co.uk

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