July 2006

New Medical Device CRO Symbios Clinical Established

Monday, July 31, 2006

Symbios Clinical, a new contract research organization (CRO) based in Minnesota, has recently begun formal operations. The CRO focuses on the medical device industry. The company began with $500,000 in start-up financing. Co-founders Ethan Rooney and Ryan Wilson began the company after careers in the medical device sector, both working for large companies. During an interview conducted by CenterWatch, Ethan Rooney elaborated on the need for such a CRO in the medical device industry:

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Super-Size The FDA

Friday, July 21, 2006

A proposal in Congress to boost funding for the FDA makes a lot of sense. But don’t stop there, Congress – a super-sized FDA would help solve many of the issues around drug safety. Make sure it’s truly independent, though, and free from pressures from the pharmaceutical industry, brought upon it by a lack of resources. Drug research reformists often suggest creating an independent clinical trials agency to perform trials for the industry, but that’s a far-fetched and unworkable solution.

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Averion Goes Public

Wednesday, July 19, 2006

The San Diego, Calif.-based company IT&E International, a regulatory compliance and validation services provider has agreed to merge with Averion, a contract research organization based in Framingham, Mass., for roughly $25 million, including $20 million of stock and notes and $5 million in cash. The new company will retain the Averion name, and allow Averion to become a publicly traded company.

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Wyeth Overhauling Phase II Program

Tuesday, July 18, 2006

Wyeth plans to make bold changes to its phase II program, cutting the number of sites participating and using more sites in China, India, Latin America and Central and Eastern Europe. Wyeth also plans to use more sites in emerging regions for its entire clinical program.

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Adapting To A New Kind Of Trial

Monday, July 17, 2006

It’s great to see the FDA making a move this week to develop guidelines for adaptive clinical trials. Their time has come, given recent advances in scientific tools, such as toxicogenomic assays.

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