DrugLogic®, Inc. a long established drug safety analytic and data solution supplier, today announced Qscan®-RM, a rapid implementation solution for small and medium organizations. This product is an extension of DrugLogic’s Qscan-ERM workflow management designed for secure hosting in an application services provider (ASP) mode. It will be available for application to public data, internal data or any combination thereof. Organizations can benefit from all workflow and data interface functions, without the hassle of a custom implementation. This service will be offered in both subscription and license form, with full value applied when upgraded to an in-house solution. Current Qscan-FDA and VAERS clients will be offered full subscription credit if they convert to Qscan-RM before June 30, 2008.
Drug safety risk management and the processes whereby companies manage the various issues that arise in drug safety (“Signal Management”, regulatory responses, among others) are often spread across various staff members who address these issues. Best practices in alerting, workflow management, document preparation and risk assessment techniques (including risk mapping) have evolved and are expected as part of a drug company’s responsibilities to manage risk. The Qscan-RM solution will expedite and ease the implementation of a major system to support this function. In addition, migration to full Qscan-ERM in-house operations will be facilitated.
“We are pleased to offer a solution with all the workflow capabilities available in our flagship Qscan-ERM offering, but one aimed at companies with fewer staff and less need for process complexity”, noted Victor Gogolak, President and Chief Executive Officer of DrugLogic, Inc. “Companies with fewer worksteps and departments still require total regulatory compliance. What we offer is an easily tailored process - a ‘starter set’ workflow, standard alert definitions - and the ability to map proprietary data based on years of experience in risk and event management. Over time, the workflow model can be adapted to growth and drug numbers. This approach removes the delays caused by the ‘blank sheet of paper’ of a new process design by building on standard drug safety assessment practices. Whether simple case series review or sophisticated drug-drug interaction is used, all processes must review, assess, and either close out or monitor the issues. Qscan-RM will take on all the load of providing data, creating the audit trail, providing automated progress through the workflow, and in the preparing of reports, including PSURs. Time will be freed for clinical assessment, not paper pushing.”
The heart of the new solution consists of three components:
- A DrugLogic-hosted secure application and data storage system with all client specific data segregated on dedicated servers
- A set of ‘templates’ for workflow, coding, alerting analysis and reporting, that can be adapted, changed, refined and saved by the users
- A system of load facilities that has resulted in a maximum client data mapping time of one week.
“The ‘templating’ approach,” according to Long Doan, chief architect of DrugLogic, “avoids the pitfalls of hardwired solutions and allows users to see and modify the processes in the system. In the past, many of these were difficult to understand and change. Just load a template, and you see immediately what the system is going to do for you.”
Qscan-RM is in the final stage of full regulatory 21 CFR Part 11 validation testing, and will be available in the second half of Q1 2008.
About DrugLogic®, Inc.
DrugLogic®, Inc. specializes in developing analytical tools and enterprise process support systems for managing risks related to drug safety issues. DrugLogic is dedicated to designing, developing and delivering products that provide the latest innovations and state-of-the art solutions in support of pharmacovigilance and drug safety surveillance practices for both pharmaceutical and biotech companies. Its proprietary Qscan® product monitors both company proprietary adverse event data and publicly available data sources. For more information, visit www.druglogic.com. |