Category Archives: Adverse Event Signal Detection

Free Webinar: Merging Multiple Drug Safety and Pharmacovigilance Databases into One Global Oracle Argus Safety System

Posted by lifescienceswebinars in Adverse Event Signal Detection, Adverse Event Signal Management, Argus, Argus Safety, Argus Safety Database, Argus Safety Suite, Clinical Data, Clinical Trial Data, Clinical Trial Data Regulatory Submissions, clinical trial software, clinical trial systems, Clinical Trials Data, Drug Safety, Drug Safety Database, drug safety software, Drug Safety System, Empirica Signal, Empirica Topics, Oracle Argus, Oracle Argus Safety, Oracle Empirica, Oracle Empirica Topics, Pharmacovigilance, Pharmacovigilance software, Pharmacovigilance System, Phase Forward Empirica, Risk Management, Signal Detection, Signal Management and tagged with , , , , , , , , , , , , , , , , , , , ,

by Eugene Sefanov

Many sponsors and CROs rely on an IT infrastructure that includes multiple disconnected safety and pharmacovigilance systems that vary by region and vendor. Although merging these systems into a single global solution may seem daunting and provide you with many technical challenges, it could be a crucial goal on the horizon for your organization.

Please join BioPharm Systems’ Dr. Rodney Lemery, vice president of safety and pharmacovigilance, for this free one-hour webinar in which he will review a recent project for a top pharmaceutical company that entailed the merging of multiple drug safety systems into one global Argus Safety pharmacovigilance system.

Specific topics that will be examined include:

  • Adverse Event Case Migration
  • Merging and Configuring
  • Data Cleansing and Consistency
  • Configuring Reporting Rules

Register to view the webinar at https://cc.readytalk.com/r/nu2vem0xprkr.

For more information about BioPharm Systems, please visit www.biopharm.com

FREE WEBINAR: USING ORACLE’S EMPIRICA TOPICS TO DOCUMENT YOUR SIGNAL MANAGEMENT PROCESS

Posted by lifescienceswebinars in Adverse Event Signal Detection, Adverse Event Signal Management, Drug Safety, Drug Safety Database, drug safety software, Drug Safety System, Empirica Signal, Empirica Topics, Oracle Empirica, Oracle Empirica Topics, Pharmacovigilance, Pharmacovigilance software, Pharmacovigilance System, Phase Forward Empirica, Risk Management, Signal Detection, Signal Management and tagged with , , , , , , , , , , , , , , , , , , , , , , ,

by Eugene Sefanov

Signal management, the detection, prioritization, and evaluation of signals, is a crucial activity that life sciences organizations should continuously perform in an effort to ensure their products are not related to excessive risks in relationship to the products’ benefits. With the emergence of comprehensive and user-friendly signal management solutions, the management of signals has become easier and more effective.

Oracle’s Empirica Topics is a powerful tool that helps companies track information and activities that are related to potential safety and pharmacovigilance signals. For example, after the creation of a signal topic, it can be delegated to members of a safety team for documenting the prioritization and evaluation of the signal. This transparent and collaborative process can protect your organization in an audit and ensure you have a well-established methodology for signal management.

Join BioPharm Systems’ Dr. Rodney Lemery, vice president of safety and pharmacovigilance, for this free one-hour webinar that will explore why and how Empirica Topics can be:

  • Implemented and configured using BioPharm’s unique methodology
  • Utilized to strengthen your pharmacovigilance systems and processes, by employing techniques promoted by the Council for International Organizations of Medical Sciences (CIOMS) Working Group VIII

Register to view the webinar at https://cc.readytalk.com/r/wjvsun6v20rp.

For more information about BioPharm Systems, please visit www.biopharm.com.