Nextrials And Formedix Integrate Platforms To Deliver Clinical Trial Database Design Tools

Nextrials And Formedix Integrate Platforms To Deliver Clinical Trial Database Design Tools
June 10, 2010

Nextrials, Inc. (, a leader in clinical research software and services, today announced that its electronic data capture (EDC) and clinical trial data management platform,PrismTM, is now integrated with the study design tools offered by Formedix. Formedix's industry leading OriginTM products include database design tools based on the data standards developed by the Clinical Data Interchange Standards Consortium (CDISC), a platform that Nextrials fully supports. In fact, both Nextrials and Formedix are CDISC Registered Solutions Providers. With this strategic partnership, Prism users can now easily build customized databases in just a few mouse clicks, reducing the overall length and cost of clinical trials by expediting study start up through reduced specification and development effort.

Visitors to the 46th Annual Meeting of the Drug Information Association (DIA), being held June 13-17 at the Walter E. Washington Convention Center in Washington, DC, can view a demonstration of Prism's integration with Formedix at Nextrials' Booth 1320 and at Formedix's Booth 446.

"We are always looking for ways to add features and functionality to Prism, so when our clients asked for the ability to build customized databases in-house, we researched the most effective way to meet this need," said James Rogers, CEO and co-founder of Nextrials. "By partnering with Formedix, we've given users the best in the industry: a powerful but easy-to-use tool to design clinical trial databases that includes the ability to automatically generate annotated electronic case report forms (CRFs), database design specifications and create submission-ready CRFs. The Formedix design toolset also enables companies to establish and use large libraries of CDISC ODM content which can be dragged and dropped from study to study, kick-starting a sponsor's study design."

Eli Lilly and Company recently made its ODM library, containing over 500 forms, 15,000 items and 3,000 codelists, available as free downloads through Formedix for use within the pharmaceutical community.

"One of Formedix's goals is to build alliances with all of the major electronic data capture (EDC) vendors in the clinical trial industry," said Mark Wheeldon, founder and CEO of Formedix. "By partnering with Nextrials, we foster another pipeline to small- to mid-range research organizations that could benefit from our product features, particularly the re-use of libraries of forms, items and codelists for creating databases. We look forward to working with Nextrials' customers."

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 Formedix

Founded by Mark Wheeldon in 2000, Formedix is a leading provider of software and consultancy services based around CDISC (Clinical Data Interchange Standards Consortium) Standards. Origin Study ModellerTM, Formedix's CDISC study design tool, has been proven to deliver a three fold reduction in study set-up times and is used by market leading biotechnology, pharmaceutical and medical device companies worldwide. Formedix's offices are based in Burlington, MA and Paisley, UK. For further information, visit or call 781-685-4995.

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. PrismTM, 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 or call 925-355-3000.