Grünenthal Improves Drug Safety, Ensures Compliance with New Regulations by Using Advanced Pharmacovigilance Solutions
 
 

Grünenthal Improves Drug Safety, Ensures Compliance with New Regulations by Using Advanced Pharmacovigilance Solutions

  • Oracle Customer:  Grünenthal GmbH
    Location:  Aachen, Germany
    Industry:  Life Sciences
    Employees:  4,200
    Annual Revenue:  $1 to $5 Billion

The Grünenthal Group is an independent, family-owned, international, research-based pharmaceutical company, headquartered in Aachen, Germany. Building on its unique position as a leader in pain treatment, its objective is to become the most patient-centric company, and thus a leader in therapy innovation.

Grünenthal is one of the last five research-oriented pharmaceutical corporations, which sustainably invests in research and development, with headquarters in Germany. These investments amounted to about 25% of the company’s revenue in 2011. Grünenthal’s research and development strategy concentrates on select fields of therapy and state-of-the-art technologies. It focuses on the intensive search for new ways to treat pain better, more effectively, and with fewer side-effects than before. Altogether, the Grünenthal Group has affiliates in 26 countries worldwide. Grünenthal products are sold in more than 155 countries, and today approximately 4,200 employees work for the Grünenthal Group, worldwide. In 2011, Grünenthal achieved revenues of US$1.23 billion.

In 2006, when European pharmacovigilance was standardized on the FDA-defined data elements used in the transmission of adverse drug reaction reports (E2B), Grünenthal selected Oracle Argus Safety, an advanced and comprehensive adverse-events management system that is cost-effective, sophisticated, and E2B-compatible. Grünenthal upgraded to Oracle Argus Safety Version 6 in 2011, enabling the company to integrate its subsidiaries automatically to the E2B-transmission format via a self-developed system and to exchange electronic data sets with pharmaceutical partners for accelerated bureaucratic processes and ensured safety. To meet adverse event signal detection requirements for newly developed drugs, Grünenthal implemented Oracle Health Sciences Empirica Signal in 2012, which satisfies all regulatory and industry reporting and analysis requirements. To further improve the automated signal detection, the Grünenthal safety data set was merged with the World Health Organization Vigibase data set to improve the electronic signal detection in Empirica Signal.

 
 

 
 

Challenges

A word from Grünenthal GmbH

  • “We aim to use gold-standard products in the pharmaceutical industry. With Oracle Health Sciences Empirica Signal and Oracle Argus Safety, we have achieved the patient-safety level that is so important to us as a research-based pharmaceutical company.” – Dr. Marc A. Zittartz, Associate Director, Global Drug Safety Application Management, Grünenthal GmbH

  • Comply with European pharmacovigilance data transmission standards
  • Find cost-effective software upgrade opportunities with value-added options
  • Improve adverse-event signal detection capabilities to ensure patient safety and meet United States and European regulatory requirements

Solutions

  • Implemented Oracle Argus Safety in 2006, ensuring effective and efficient compliance with regulatory and industry standards for drug safety data processing
  • Upgraded to Oracle Argus Safety Version 6 in 2011 to achieve time and cost savings and ensure stable software
  • Used Argus’s capabilities to enable fully-electronic data exchanges with affiliates
  • Fulfilled United States and European regulatory requirements with the leading signal detection and management software addressing these issues, Oracle Health Sciences Empirica Signal 7.3
  • Increased patient safety through automated signal detection on a combined Grünenthal/World Health Organization data set and the evaluation of these signals