Drug Safety Firm BioSoteria Announces Exponential Growth in 2009
Emeryville, CA - January 28, 2010 - BioSoteria, Inc., a privately held drug safety services and training company, announced today that revenues grew 67% in 2009 compared to 2008. The strong growth came from an increase in new client contracts, expanded drug safety services to existing clients, and the launch of eLadder™ Safety, a first-in-class comprehensive pharmacovigilance eLearning curriculum.
In 2009, BioSoteria provided consulting and safety operational services to more than 40 biotechnology and pharmaceutical companies across the US and Canada. The company’s substantial increase in revenues in 2009 was realized as clients increasingly engaged BioSoteria for strategic consulting and services in areas such as risk evaluation and mitigation strategies (REMS) and safety signal detection and analysis. Professional staff grew by 19% to support the demand for BioSoteria’s drug safety services and training offerings.
Also contributing to the increase in corporate growth was the launch of BioSoteria’s eLadder™ Safety pharmacovigilance training curriculum. The first three eLearning courses of the curriculum released in 2009 were enthusiastically received by drug safety professionals, those aspiring to enter the field of drug safety, and by biopharmaceutical companies and contract research organizations (CROs) who wish to train 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 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, 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 other health databases
Pharmacovigilance department audits and US/EU inspection readiness
Product litigation consulting and support
Support to clients with complete response letters and programs placed on clinical hold
•eLadder™ Safety, the first comprehensive drug safety training curriculum delivered in a true multimedia eLearning environment, was launched, with three core competency courses for drug safety professionals:
Course 1: Drug and Device Development and Regulation
Course 2: Clinical Safety Surveillance
Course 3: Postmarketing Pharmacovigilance
•The BioSoteria leadership team expanded with the addition of James Buchanan, PharmD, as Senior Vice President of Pharmacovigilance and Risk Management. Dr. Buchanan has over 20 years of industry drug safety, clinical development, and medical information services experience, and he has served as Chief Safety Officer at two past companies prior to joining BioSoteria.
•BioSoteria moved its corporate headquarters to Emeryville CA, central to many biotech and pharmaceutical companies in the San Francisco Bay Area, to accommodate the current and future growth in its staff and drug safety services.
•DSI: Drug Safety Intelligence, BioSoteria’s weekly drug safety e-newsletter, grew to nearly 1100 subscribers.
•BioSoteria’s 3rd Annual Pacific Drug Safety Summit ( PDSS09) had the highest attendance, sponsorship and satisfaction rankings to date, making it one of the most well attended pharmacovigilance conferences in the US of the year.
•Several of the BioSoteria senior management team accepted faculty and instructor appointments and lectured throughout the year at Universities, Schools of Pharmacy, as well as industry conferences, on drug development and drug safety.
About BioSoteria, Inc.
BioSoteria provides innovative drug safety services and educational programs to the biopharmaceutical industry. The company offers a wide range of pharmacovigilance services throughout the product lifecycle, including premarketing clinical safety surveillance, postmarketing pharmacovigilance, and risk management programs. For more information about BioSoteria, please visit the company’s website at http://www.biosoteria.com, email .(JavaScript must be enabled to view this email address) , or call 1-866-660-5553.
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