Citing the need to streamline product safety reporting as the number and complexity of global trials increases, as well as the heavy cost of late-stage failures in clinical development, US-based business software giant Oracle has agreed to acquire safety solutions provider Relsys International for an undisclosed sum.

The combination of Relsys’ drug safety and risk management solutions with what is already “the industry’s most comprehensive suite of software applications for clinical development” is expected to deliver the only applications portfolio “that supports end-to-end drug safety processes across clinical development, post-market surveillance and patient care”, Oracle said.

The company set up its Health Sciences Global Business Unit in June 2008, with a strategy to provide an all-embracing software solution for clinical trials, product safety and risk management.

The Relsys offering, which includes its flagship Argus Safety adverse-event reporting system, complements the Oracle range with open, configurable and modular solutions, comprising a unified product suite that allows customers and partners to integrate with legacy systems and other healthy sciences software, Oracle noted.

In addition to its leading adverse events reporting software, Relsys brings significant domain expertise in delivering safety, pharmacovigilance, risk management and analytics solutions to customers globally.

According to Oracle, combining the two companies’ resources and technology will result in a comprehensive drug safety application suite that:

- Supports an integrated risk-management strategy ranging across clinical development, post-market surveillance and health delivery. At the moment, Oracle comments, safety monitoring data are collected and managed “in silos by departments across organisations responsible for developing and delivering drugs and therapies to patients and consumers”.
- Enables customers to develop safer and more cost-effective therapies, as complex regulatory requirements, costly late-stage development failures and post-market safety concerns drive industry to re-examine its product safety strategies.

- Provides better insight and visibility across safety processes through “an integrated and comprehensive view of data across adverse events, clinical studies and observational data”.
- Helps to identify safety issues earlier in the development process, with the potential to reduce significantly the costs associated with bringing drugs and medical devices to market.
- Offers a best-in-class, comprehensive health sciences software suite from a single business software provider.

The transaction is expected to close in the first half of 2009, with Relsys management and staff becoming part of Oracle’s Health Sciences Global Business Unit.