Drug Discovery And Development Company Neurogen Selects QUMAS R&D Suite
QUMAS, a leading provider of quality management and regulatory affairs solutions, today announced that Neurogen Corporation (NASDAQ: NRGN) has selected the new QUMAS R&D Suite™ for its content management needs for Nonclinical, Clinical, CMC, Safety, Quality, and Regulatory groups.
Neurogen is a drug discovery and development company focusing on small molecule drugs to improve the lives of patients suffering from disorders with significant unmet medical needs. The Company currently has five programs in Phase II or Phase I clinical testing for insomnia, pain, Parkinson's disease, Restless Legs Syndrome (RLS) and obesity.
Launched in conjunction with the Drug Information Association's (DIA) 20th Annual Conference for Electronic Document Management (EDM) in Philadelphia, the QUMAS R&D Suite is already gaining traction within the life sciences industry. In addition to an attractive price point, the QUMAS R&D Suite also eliminates the need for companies to go out and assemble an R&D solution on their own, consuming time, resources and adding to costs and complexity in managing the solution over time. QUMAS, by design, selected best-of-breed vendors and products, including ISIWriter from Image Solutions, Inc., and combined them into one, integrated solution that is optimized to work out of the box.
"ISIWriter adds a layer of protection and control to Word documents, ensuring the kind of consistent formatting that is needed for authoring medical documents," said Brian Costello, channel program manager for Image Solutions, Inc. "ISIWriter goes far beyond standard templates with built-in instructional text and references to specific guidances, allowing users to create consistent, reliable scientific and regulatory content."
Life sciences organizations today are challenged to maintain product quality, productivity, ROI and compliance while at the same time producing 10-15% growth for their shareholders. To be competitive, biopharmaceutical companies must streamline their product lifecycles, including IND and NDA approvals, as well as validation of the production process.
"Given the exponential nature of many of the regulatory documents required by the FDA, organizations find it extremely challenging to quickly identify, assemble, review and approve all the relevant documents required for a submission," said Ken Hayward, head of life sciences for QUMAS. "The QUMAS R&D Suite provides Neurogen and other life sciences companies with an automated solution to expedite their new drug applications. We believe these organizations can anticipate seeing more efficient results faster and over a sustained period of time."
About Neurogen
Neurogen Corporation is a drug discovery and development company focusing on small molecule drugs to improve the lives of patients suffering from disorders with significant unmet medical need, including insomnia, Parkinson's disease and restless legs syndrome (RLS), pain, depression, and obesity. Neurogen conducts its research and development independently and, when advantageous, collaborates with world-class pharmaceutical companies to access additional resources and expertise.
About QUMAS
QUMAS is a leading developer of enterprise compliance management solutions designed to help life sciences organizations meet industry and government standards for 21 CFR Part 11, cGxP, Quality, Regulatory Affairs and Clinical Operations. With over a decade of experience, QUMAS is helping companies accelerate business processes, reduce costs and improve quality. From content lifecycle management, business process and change management to reporting and analysis, QUMAS Compliance Suite is successfully enabling global life science organizations to proactively manage their regulated content and processes in a secure and compliant way. For more information visit www.qumas.com.
About Image Solutions, Inc.
With operations in the US, Europe and Asia, Image Solutions, Inc. (ISI) is a global, privately-held company founded in 1992 with an established reputation as the worldwide leader in providing comprehensive software and outsourcing solutions to clients in the Life Sciences, Government and other regulated industries. Today, ISI performs work for over 120 clients worldwide, including the top 50 Pharmaceutical and Biotech organizations worldwide.
Since 1992, ISI has pioneered innovative electronic submission and document management tools, earning an unprecedented reputation of delivering exacting quality, while improving their clients' speed-to-market regulatory approval timeliness for new medicines.
ISI World Headquarters are located in Whippany, New Jersey, with west coast offices in San Francisco, California, and satellite offices throughout the United States. ISI International is headquartered in Frankfurt, Germany with additional offices in and Bristol, United Kingdom. ISI Research supports operations in Seoul, South Korea, and through a partnership with CAC Corporation, ISI also markets its products and services in Japan and the Pacific Rim countries. For more information visit their Web site at: www.imagesolutions.com.
Source: QUMAS