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Drug Safety Firm BioSoteria Announces Exponential Growth in 2009
Date:1/28/2010

in their safety personnel. The BioSoteria website was upgraded to include an eCommerce engine that allows individuals and small companies to purchase access to eLadder™ Safety courses online. Enterprise license options for corporate/institutional buyers were also introduced.

“I am very pleased with our leadership position in drug safety and continued growth of our company in 2009,” said Sally Van Doren, PharmD, President, CEO and Founder of BioSoteria. “In just three years, BioSoteria has grown from a small consulting firm providing services to primarily West Coast clients to a well recognized, full-service pharmacovigilance service and training provider across North America with a dedicated team of nearly 50 drug safety professionals, educational and training staff and operational support. We look forward to continuing our high quality services and extending our offerings in 2010 through business expansion and strategic partnerships.”

Highlights of 2009
-- Safety consulting and operational services were provided to more than 40 biotechnology, pharmaceutical, and over-the counter (OTC) companies, including:

 
  • Case intake, data entry, narratives, coding, reporting to regulatory authorities, periodic safety reporting, company core data sheet (CCDS) development and maintenance, and labeling updates
  • Patient narratives, integrated summary of safety (ISS) and other medical writing support for NDAs, BLAs, and MAAs
  • Hosted safety database solutions
  • Risk management/REMS planning, document writing, and implementation
  • Safety signal detection and analysis using client, FDA AERS, and o
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Source: PRWeb
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