BioPharm Systems


Posts tagged with "phase forward empirica"

Using Oracle’s Empirica Topics to Document Your Signal Management Process

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

For more information about BioPharm Systems, please visit


by Eugene Sefanov

All business processes are subject to some level of risk. Key to the long term viability of any company is the critical need to identify the risks, quantify them, minimize them, and have a clear plan for dealing with any residual risks.

Organizations try to mitigate risks by implementing systems that support the company’s business processes. Commercial software systems that are available from vendors such as Oracle include many capabilities which, if implemented properly, greatly reduce the risks in the business process.

The implementation of complex systems is, in itself, a risky process. Organizations like BioPharm Systems have been able to use their wide range of experience to develop pre-configured and pre-validated solutions that help reduce the risks during the implementation of a clinical trial management system (CTMS) and a safety system.

This one and a half-hour webinar will provide an overview of business risks related to clinical and safety systems and will illustrate how the risks inherent in implementing complex CTMS and safety systems can be significantly reduced.

View a recording of the webinar at

For more information about BioPharm Systems, please visit