Nextrials’ Prism™ Offers Key Functionalities Needed for Long-Term, Multi-Site, Multi-National Post-Marketing Clinical Studies
SAN RAMON, Calif.--(BUSINESS WIRE)-- Nextrials, Inc. (www.nextrials.com), a leader in clinical research software and services, is experiencing an upswing in registry studies, thanks in part to the flexibility of its electronic data capture (EDC) and clinical trial data management platform, Prism™. With key features that include flexible form design with conditional fields and start page customization to facilitate branding and ad hoc reporting, Prism gives sponsors a powerful platform for mining registry study patient data via a very user-friendly interface.
EKOS® Corporation, a leader in providing ultrasound-assisted, fluid infusion catheters for thrombolytic therapy, has conducted multiple registry studies using Nextrials’ Prism.
“The medical device industry seems to be moving toward more post marketing studies, perhaps because the quickest way to new device approval is not necessarily the best way to convince the market,” said Jocelyn Kersten, vice president of regulatory and clinical affairs at EKOS®. “For example, physicians and hospital administrators want to know who has used a new treatment and for how long. Registry studies can be used for validation.”
Registry studies are conducted to learn about a drug, treatment or medical device in actual use, studying its effectiveness and safety in a broader patient population. Often, registry studies are conducted in multiple countries at multiple sites, over long periods of time – typically years in duration. Sponsors of registry studies are sensitive to not only economics, but to the ease of use, security and storage capabilities of data collection and management tools.
“We are constantly assessing Prism to ensure it meets our customers’ needs for different study phases,” said James Rogers, CEO and co-founder of Nextrials. “As a result, Nextrials has been fortunate to win a number of registry studies over the last year. With the FDA putting more emphasis on product safety and comparative effectiveness, we believe the increase in post marketing study opportunities will continue.”
Nextrials has been a pioneer in the industry’s effort to integrate EDC platforms with those in use by multiple electronic healthcare record (EHR) systems. Attendees at the 2010 Society of Clinical Data Management conference, being held October 17-20 at the Hyatt Regency Minneapolis (MN), will see a demonstration of Prism’s EHR integration for clinical research during the attendee breakfast on Monday, October 18, at 7:30 a.m. Attendees can also learn more about Nextrials and Prism in booth 311 during the conference.
Nextrials’ award-winning Prism melds sophisticated clinical trial management functionality with EDC in a single, integrated package. By receiving a constant flow of data, Prism enables sponsors and sites to fully utilize real-time integration of disparate information and data sources, such as a hospital’s EHR or patient records, to better provide a continuum of care for patients enrolled in clinical trials. Prism is the only platform to be successfully used in a multi-site study where real-time, live patient data was collected and shared by what had previously been two disparate data management platforms.
About Nextrials, Inc.
Founded by pharmaceutical researchers in 1999, Nextrials offers 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 1,500 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.
Rachel V. Berry, 253-853-5151, ext. 223
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INDUSTRY KEYWORDS: Technology Data Management Software Health Biotechnology Clinical Trials Hospitals Medical Devices Pharmaceutical Research Science