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San Ramon, CA — June 27, 2005
Nextrials and Galt Associates Form Partnership to Expedite Data Exchange and Track Adverse Events and Safety Trends During Clinical Trials
Nextrials, Inc., a leader in clinical research software and services, today announced that it is establishing a partnership with Galt Associates, an international leader in managing risk through information, to offer customers expedited automatic coding of real-time data being exchanged during clinical trials. Through tight integration with Galt's dsNavigatorTM, Nextrials' Prism® software offers pharmaceutical, biotechnology and medical device researchers the industry's first electronic data capture and safety alert system that also quickly and accurately auto-codes drug and event terms using MedDRATM (Medical Dictionary for Regulatory Activities) and WHO Drug (World Health Organization). The result is a single solution for improved workflow and management of safety trends during investigational studies, thereby speeding novel drugs and treatments to market.
"The industry is fast moving toward electronic data capture and new, automated clinical trial methods to get new drugs into the pipeline while more effectively safeguarding enrolled patients," noted Y. Renee Lewis, president and CEO of Galt Associates. "Through our partnership with Nextrials, we can offer the industry the first product that facilitates the exchange of automatically coded data across multiple test sites and multiple studies in real-time. This provides immediate electronic alerts if safety trends are identified."
Now in widespread use globally, Nextrials' Prism is a fully integrated clinical trial management and EDC product that includes a full featured safety management system for monitoring ongoing safety data and reporting outcomes to regulatory authorities. Galt's dsNavigator is a proven and respected web-based solution that offers quick and effective coding of drug and event terms within an easy-to-use, customizable interface for searching, navigating, batch and interactive auto-encoding, as well as dictionary management.
"By joining the strengths of Prism and dsNavigator, we are responding to the emerging market need to track safety profiles in innovative new ways," said Anthony J. Costello, co-founder and vice president of product development and data services for Nextrials. "Prism's built-in safety management functionality is significantly enhanced by integrating the kind of real-time event coding that has made dsNavigator a leader in the industry. It's one thing to provide sponsors with faster access to raw patient information; it's an important next step to provide immediate access to coded terms that can be used to understand complex safety trends involving large amounts of information."
Visitors can view live demonstrations of Prism at Nextrials' booth #1851, and dsNavigator at Galt Associates' booth #1609, at the Drug Information Association's 41st Annual Meeting, being held at the Washington Convention Center in Washington, DC June 26-29.
About Galt Associates
With over a decade of experience, Galt is an international leader in helping clients manage risk through information. Galt's evidence-based solutions integrate the recognized expertise of its medical and scientific personnel with innovative technologies to ensure timely answers to clients' critical questions. This integrated approach allows Galt to deliver medical risk management and communication strategies that address the benefits and risks associated with the full range of medical therapies and interventions. Galt supports over 70 pharmaceutical, medical device and biotechnology companies, as well as CROs and research institutions located throughout the U.S. and Europe. For more information about Galt's products and services, visit www.DrugSafety.com or contact them at info@galt-assoc.com or +1 703-547-3388.
About Nextrials, Inc.
Founded by pharmaceutical researchers in 1999, Nextrials Innovates for LifeTM by offering today's most novel products and services for speeding the delivery of life-saving drugs and medical devices to market. Prism®, its award-winning Electronic Data Capture (EDC) solution, has been used at over 200 research sites to streamline the initiation and management of clinical trials. The company is headquartered in the San Francisco Bay area. For more information, visit www.nextrials.com or call 925-355-3000.
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