San Bruno, CA (January 6, 2009) - BioSoteria, the leading West Coast provider of drug safety and risk management consulting and educational services, announced today that the company realized significant client growth in 2008 with 29 new clients, which represents more than a doubling of clients from 2007.
BioSoteria (www.biosoteria.com) offers a variety of premarketing safety surveillance postmarketing pharmacovigilance services, including new contracts in 2008 which include but are not limited to:
• Authorship of the entire Module 2 of the CTD including the ISS and ISE or an NDA submission
• Safety analyses and regulatory responses to regulatory authorities for clinical holds, post NDA submissions, safety signal evaluations, and post PSUR regulatory queries
• Authorship of several PSURs and other periodic safety reports
• Full service safety surveillance for several clients with products in clinical development
• Cumulative safety analyses of client marketed products for descriptive and safety signal detection
• Data integration and authorship of a statistical analysis plan in preparation for an ISS
• Infrastructure of safety departments, compliance and SOP development, and selection of safety databases
• Support of end of phase 2 safety analyses and preparations for phase 3
• Development of core data sheets for multiple marketed products, and DCSIs for investigational products
• Advisement on establishment of an Epidemiology department to institute pharmacoepidemiology activities
In addition to the new consulting contracts, BioSoteria is pleased to announce the launch of the first of a comprehensive series of drug safety eLearning training courses through its innovative eLadderTM Safety eLearning programs. The first course is entitled “Drug and Device Development and Regulation” and can be purchased on line. Additional eLadderTM Safety courses will be released throughout 2009 on a variety of drug safety topics.
“We are pleased that many clients have sought our services and several have been repeat customers,” said Sally Van Doren, President and Chief Executive Officer of BioSoteria. “We are very proud to be launching a first-of-its kind eLearning program specifically targeting drug safety topics in a course series that will offer drug safety professionals, and those interested in drug safety career track, an opportunity to learn through this innovative, cost effective, interactive program.”
About BioSoteria
BioSoteria delivers high quality, innovative drug safety and risk management consultant services and educational programs to the biopharmaceutical and healthcare community.
Our Mission statement:
BioSoteria is committed to client satisfaction and to providing its clients and strategic partners with comprehensive, knowledgeable, regulatory-compliant, cost-conscious recommendations for drug and medical product safety surveillance consultant services and training. Our commitment to patient safety and public health, as well as the education of medical product safety personnel, are hallmark to our corporate values and mission. We are dedicated to increasing the numbers of qualified medical product safety personnel in academic, governmental, and industry settings through our outreach to health care professionals (e.g., nurses, pharmacists, physicians) in clinical practice and to improving the skills and competencies of existing medical product safety personnel. These are the driving principles by which we conduct business and enter into collaborations with our clients and strategic partners.
For more information about BioSoteria and our services and educational programs, please email contact@biosoteria.com, visit our website at http://biosoteria.com/contact/, or call +1 866-660-5553 (+1 650 616 4151 outside the US).
