Emeryville, California (EastBayDaily) — BioSoteria, Inc., Drug Safety and Risk Management Specialists, announced today that “Success Factors for Implementing an EDC to Safety System Data Interface,” has been just added to the tutorial line-up at the Pacific Drug Safety Summit. The tutorial is sponsored and presented by Medidata and will take place Thursday, September 15, 2011 at the Hyatt Regency, San Francisco Airport.
The tutorial will discuss the challenges of handling paper SAE case forms and the success factors to consider when implementing an electronic method of processing data from EDC to Safety Systems. Reporting serious safety events to regulatory bodies in a timely manner during the course of a clinical study is critical for sponsors. But in today’s paper and fax based practices, to collect serious adverse event (SAE) case information from investigational sites and then manually entering it into safety reporting systems, are costly, laborious and inefficient. EDC to safety system electronic data interfaces are innovative solutions that pave the way to a more efficient and accurate process for collecting and communicating SAEs and related data; and achieve greater reconciliation efficacy. The tutorial will focus on leveraging a data interface from EDC to a safety system to: Eliminate redundant safety data entry Increase productivity Speed the processing time of cases and Reduce reconciliation between the two systems.
The Fifth Annual Pacific Drug Safety (PDSS) will take place September 15-16, 2011 at the Hyatt Regency San Francisco Airport in Burlingame, CA. BioSoteria is an authorized provider of Continuing Education Credits for California Registered Nurses and Pharmacists. To register for this newly added tutorial and more information on the Pacific Drug Safety Summit, go to http://www.PacificDrugSafetySummit.com.
About BioSoteria Founded in 2007 with a strong vision of a progressive drug safety and pharmacovigilance consulting services and education, BioSoteria serves the outsourcing needs of the pharmaceutical industry. From strategic risk management consulting services and full-service drug safety operational capabilities to world-class award winning pharmacovigilance training and education programs, BioSoteria provides unmatched experience, expertise, and leadership to support your company’s efforts to maximize your product’s benefit-risk profile. For more information about BioSoteria and our safety consultative and training services, go to http://www.biosoteria.com.