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BioSoteria Announces New Tutorial Added to the Pacific Drug Safety Summit
Category: News
  -  Posted on: Friday, 09 September 2011 00:00

Emeryville, CA (PRWEB) September 09, 2011 -- 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 www.PacificDrugSafetySummit.com.