Enabling Risk Management: from safety signals to benefit:risk management (White Paper - February, 2008)

Pharmaceutical companies are broadening their focus from transactional case processing to more proactive lifecycle risk management, of which AE signal detection is a key component. However, enthusiasm for this new technology has matured with the gradual realization that the signal detection in itself does not promote adequate risk management, as it also requires a structured methodology for (post) signal management.

Enabling Clinical Safety: Solutions Brief

Clinical Safety is one of the key initiatives being undertaken in the ongoing transformation of the modern day SRM (Safety & Risk Management) departments. While the ultimate objectives of clinical safety include instream safety, adaptive trial management, and Phase IV management, operational excellence is often the first major gain.

Partners in Safety - Issue 1
Interview with Chris Jabbal, Chief Services Officer
The Future of Relsys' Global Professional Services organization

Partners in Safety - Issue 2
Interview with John Loucks, Chief Customer Officer
Discussion of how pharma can move beyond drug safety to patient safety

Software-as-a-Service: The New Paradigm in Pharmacovigilance (June, 2008)

The hosting model (also known as Software-as-a-Service or “SaaS”) to pharmacovigilance is increasingly gaining traction among pharmaceutical companies seeking to optimize drug safety processes. SaaS – “software that is owned, delivered and managed remotely” – has already been used successfully in the clinical space. A hosted drug safety system enables a bio-pharmaceutical company to realize all of the benefits of a PV system without the costly overhead of IT hardware and support.

Enabling Risk Management: From safety signals to benefit:risk management (February, 2008)

Pharma companies are increasingly focusing on signal detection to improve drug safety. However, signal detection is not the goal - it is merely a component of a much larger process that ultimately leads to an enhanced benefit:risk profile. This webcast will discuss how a "structured" signal management approach facilitates pharma's risk management initiatives.

Safety Meets eClinical
Systematic opportunities to improve risk management & product ROI
Presentation from the 2007 eTrials Annual User Conference - Orlando, Florida, USA

Safety Oriented Pharma Company
Presentation from November 2007

Convergence of eClinical and Safety: ROI Opportunities & Key Enablers
Presentation from Pharmacovigilance 2007, London, U.K.

Enabling Risk Management: Systematic Opportunities
Presentation from 2nd Annual Drug Safety & Pharmacovigilance Conference - Amsterdam, The Netherlands

Relsys Enabling 'Structured' Signal Management
Bio-IT World Web Article - September 13, 2007

"The same mathematical foundations used by banks to identify fraud are now being applied to the business of mining adverse event data for signals of true drug safety problems. In light of “more mature” signal detection and management technology — and encouragement from drug safety regulators to adopt it — pharmaceutical companies 'have to be more proactive,' says Sanket Agrawal, chief strategy officer at Irvine, CA-based Relsys International."

New Directions in Drug Safety
Bio-IT World Web Article - March 3, 2007

"The drug safety departments of most pharmaceutical companies have become too burdened with operations to effectively manage risk. A new approach is needed to detect problems earlier, communicate clear benefits, and prevent a risk-averse public from potentially blocking important advances."

Drug Safety Landscape Shifts
ClinPage Web Article - February 1, 2007

"...And yes, the FDA’s attempt to bolster its own drug safety efforts can now be pondered by a predictably divided and intemperate Congress. But the issue of safety is squarely on the public agenda and is likely to remain there this year.

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