Nextrials Introduces Industry’s First Automated Tracking and Electronic Notification System for Safety Trends in Ongoing Clinical Trials

May 17, 2005

Applied Clinical Trials

Nextrials’ Prism® now offers enhanced reporting capabilities and additional safety features

San Ramon, CA -- May 17, 2005 -- Nextrials, Inc., a leader in clinical research software and services, today announced that its flagship Prism software now offers the industry's first electronic messaging system for identification and tracking of safety trends, providing researchers with early alerts of potentially significant safety developments. One of the most advanced Electronic Data Capture (EDC) products on the market, Prism's enhanced safety features give research professionals the ability to set threshold tolerance levels for investigational studies of biopharmaceuticals and medical devices. Researchers can then monitor these thresholds in real-time across multiple test sites and multiple studies, receiving electronic alerts when data trends point to potential safety concerns.

The new system solves two pressing problems for the industry by providing immediate access to data obtained across multiple project sites and studies while helping minimize public and financial risks when clinical data shows safety concerns.

"This new capability is in direct response to the industry's increasing focus on safety," notes James Rogers, co-founder and CEO of Nextrials. "Researchers have traditionally reviewed safety data on a periodic basis by analyzing data that is weeks or even months out-of-date. This delay exposes sponsors and patients to unnecessary risks. Prism's safety alert system provides life sciences companies with an early warning system for clinical trials that increases patient safety."

Prism's advanced data mining capability spots and analyzes multi-project safety trends, even in cases where the overall clinical trial remains below threshold levels, and electronically sends notification to researchers. This increases the industry's ability to conduct significant, complex clinical research in a safe and cost-effective environment.

Nextrials has also added international reporting capabilities to Prism, enabling pharmaceutical, biotechnology and medical device firms to more quickly comply with regulations for safety reporting in countries around the globe.

Visitors to the BIO-IT World Conference + Expo, held May 17-19 at the Hynes Convention Center in Boston, can view live demonstrations of Prism at Nextrials' booth #708.

About Nextrials, Inc.
Founded by pharmaceutical researchers in 1999, Nextrials offers today's most innovative 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.