invivodata Introduces ePRO–EDC Integration for Medidata Rave That Leverages CDISC Operational Data Model Standards
FOR IMMEDIATE RELEASE
invivodata Introduces ePRO–EDC Integration for Medidata Rave That
Leverages CDISC Operational Data Model Standards
PITTSBURGH – April 16, 2007 – invivodata® inc., the industry leader in electronic patient reported outcomes (ePRO) solutions for global clinical research, today announced that its ePRO–EDC integration for Medidata Rave® is now a standardized, configurable integration link that leverages Clinical Data Interchange Standards Consortium (CDISC) Operational Data Model (ODM) standards. The solution can be quickly configured to meet the needs of each trial protocol and is also fully validated and 21CFR part 11-compliant. This further strengthens invivodata’s partnership with Medidata Solutions, a global provider of electronic clinical data capture, management and reporting solutions.
The joint solution enables PRO data recorded on invivodata’s DiaryPRO® handheld electronic patient diary and Case Report Form (CRF) data captured on Medidata Rave electronic clinical data management platform to be viewed within a single system.
“We decided to base our ePRO–EDC integration on CDISC ODM standards to reduce the product specifications required and make the system quick and straightforward to implement,” said Doug Engfer, president and CEO of invivodata. “We felt that it was in everyone’s best interest to create a standard, reusable process for ePRO–EDC integrations that could reduce costs and time required to implement. It was also a logical extension of invivodata’s strong partnership with Medidata.”
”We are very excited about this integration of Medidata Rave and invivodata’s DiaryPRO, as it fills a growing need for sponsors who are continuing to look for technologies that speed and streamline the clinical development process,” said Glen de Vries, Medidata co-founder and chief technology officer. “With this integrated solution, sponsors are able to quickly and easily view ePRO data within Medidata Rave, allowing for unified access to more comprehensive patient data.”
invivodata’s ePRO–EDC integration link provides sponsors with a comprehensive, integrated view of clinical trial progress, allowing them to review data and resolve potential issues more easily. Patient assessments, visit tracking information, and other protocol-specific information are all available within Medidata Rave, giving sponsors greater visibility into site and subject performance.
The solution also grants study sites rapid access to trial data so that investigator personnel can actively monitor subjects’ behavior and take proactive measures if necessary to improve their compliance with the protocol.
For those who would like to learn more and to see this integration in action, invivodata and Medidata will co-present at two events during the CDISC European Interchange, which will be held at the Grand Hotel Suisse Majestic in Montreux, Switzerland, April 23–26. Michael Posey, product manager at invivodata, and Andrew Newbigging, senior director of research and development at Medidata, will conduct a demonstration of the integration in the “CDISC End to End Workshop” scheduled to take place April 23–24. Posey and Newbigging will also discuss how the use of CDISC standards helps speed ePRO–EDC integrations, in a presentation titled “eDiary and EDC System Integration: The Importance of Using CDISC ODM Standards” on April 26 from 9 a.m. to 10:30 a.m. CEST. Further information on this event can be found at http://www.cdisc.org.
About Medidata Solutions Worldwide
Medidata Solutions helps the world’s leading pharmaceutical, biotechnology, medical device and research organizations maximize the value of their clinical research investments. Innovative process design, technology and services streamline clinical trials by providing early visibility to reliable clinical data—the lifeblood of every research organization. Working with companies and institutions both large and small, Medidata Solutions helps clinical researchers safely accelerate the process of bringing life-enhancing treatments to market—on six continents and in more than 80 countries. Medidata Solutions brings significant value to its broad client base with deep clinical experience and expertise in more than 20 therapeutic areas, projects in Phase I, II, III, IV, registries and surveillance, and studies with thousands of investigators and tens-of-thousands of subjects. For more information, please visit www.mdsol.com.
About invivodata inc.
invivodata combines behavioral science, information technology and clinical expertise to capture clinical trial data of the highest integrity directly from patients. invivodata’s electronic Patient Reported Outcomes (ePRO) system delivers high-quality patient self-reported data by driving patient compliance with the protocol and eliminating recall biases that plague self-report studies. The invivodata solution, which includes DiaryPRO for real-time PRO data collection and SitePRO for site-based PRO data collection, provides access to study data, giving researchers and sponsors visibility into study progress and improving trial efficiencies. invivodata’s solution has been used in more than 180 trials and is the industry-leading eDiary system in delivering primary efficacy data for FDA drug approvals. invivodata inc. is a privately held company with global headquarters in Pittsburgh, Pa., USA; its European headquarters are in London, England; and its technology development center is in Scotts Valley, Calif., USA.
Contact:
invivodata inc.
Media Relations
Chris Vogel
(412) 390-3000, ext. 3513
cvogel@invivodata.com
Waggener Edstrom Worldwide
Healthcare Practice
Lisa Osborne, Account Director
(202) 326-0793
lisao@waggeneredstrom.com