DrugLogic^®, Inc. Announces SafeStart Hosting^SM of Qscan^®-ERM, a Novel Workflow Solution for Pharmacovigilance

RESTON, Va.--(BUSINESS WIRE)--DrugLogic^®, Inc., an established provider of drug safety solutions, today announced the introduction of SafeStart Hosting^SM for Qscan^®-ERM. SafeStart Hosting allows customers immediate access to a fully validated workflow system with roles management, workflow and workstep (task) management, advanced statistical analysis, and reporting functions for AERS, WHO and VAERS data in a full audit trail vendor-hosted environment.

By providing Qscan-ERM in a hosted environment, DrugLogic offers its clients secure and fully configurable workflow management for individuals and departments that participate in drug safety surveillance across the entire enterprise. Current Qscan subscribers already have been upgraded with enhanced statistical and usability features. They now have the opportunity to add the configurable workflow module with roles management and executive reporting modules for a nominal cost.

Drug safety workflow is an emerging need as drug companies set up standard operating procedures (SOPs) for pharmacovigilance; both the “signaling” of possible issues, and the managing of these issues through resolution. This platform allows clients to model workflows, train staff, and refine procedures using AERS, WHO and VAERS data without the need to process all the internal information on the proprietary databases. Once established, the workflow and standard operating procedures can be seamlessly transitioned to full production on internal data. The multiple workflow capability of Qscan-ERM also affords clients the ability to manage safety data in clinical R&D, epidemiology, and post-market safety departments.

“SafeStart Hosting is a fresh approach to the complexities of workflow and SOP development. A major driver, as we saw it, is the evolving need in many companies of operating procedures for drug safety risk management and the related processes,” stated Victor V. Gogolak, President and Chief Executive Officer of DrugLogic. “The hosted ASP model for workflow is novel, but will alleviate many concerns. By using our hosted data, teams can explore SOP approaches and techniques immediately and with relative ease. Of course, the full adoption of Qscan-ERM for use with proprietary internal data will give clients the unique ability to compare their product data directly with FDA and UMC data worldwide. The Workflow and Roles modules in Qscan-ERM can adapt to any SOP business process design. Even transfers between departmental process workflows are handled easily so companies can explore processes that are more efficient, using their entire team of global experts that are all managed by the same workflow rules.”

The new system is available immediately to existing and new clients for application with the hosted public data. For those wishing to view internal data, DrugLogic will offer dedicated, secure and isolated servers that can be remotely updated with internal safety reports on a regular schedule. Several secure options, including interface to dedicated networks and VPNs, will be supported. All prior data, workflow events and reports can be seamlessly migrated in the transition to internal hosting.

“With several major installations over the past two years, we have seen the need to explore different workflow approaches. Handling workflow and internal data transitions separately, without having to exercise SOPs on extensive internal report volumes would greatly simplify implementations. This approach gives clients a real-world feel of SOP activity, and can refine their procedures using a subset of issues,” said Steve Wordham, DrugLogic’s Vice President of Client Operations and Chief Technical Officer. “Departments such as epidemiology, regulatory affairs and drug safety can explore and even provide partial production capability without having to commit to an internal infrastructure upgrade. We envision smaller departments, such as epidemiology and research, satisfying many production needs. For drug safety monitoring, they will then have the choice to stay remotely hosted or to transition to an internal system with no information or effort lost. The system, of course, is fully validated for compliance.”

As part of the new SafeStart program, DrugLogic will offer a “starter set” of workflows and templates to help clients begin taking advantage of Qscan-ERM. For clients that would like additional help in developing their procedures, DrugLogic will provide SafeStart consulting services. The new system is designed to transition rapidly to an internally hosted environment at client sites for use with proprietary, internally-maintained case data. Alternative configurations allow for proprietary hosting at DrugLogic’s secure site on client dedicated servers.

For the next six months, DrugLogic will offer attractive reductions for current and new subscribers to add this capability to existing subscriptions. Pilot programs with small numbers of users will be offered.

About DrugLogic^®, Inc.

DrugLogic^®, Inc. specializes in developing fully validated analytical tools and enterprise process support systems for the business of pharmaceutical safety operations. DrugLogic designs, develops, and delivers products that provide the latest innovations in support of pharmacovigilance and drug safety surveillance practices. For more information, visit www.druglogic.com or call 1-800-393-1313.