FOR IMMEDIATE RELEASE
invivodata and Medidata Solutions Announce
Integration of Diarypro and Medidata Rave
Nabi Biopharmaceuticals Deploys Integrated Solution to
Increase Trial Efficiencies and Improve Patient Safety
PITTSBURGH and NEW YORK, NY – August 29, 2006 – invivodata® inc., the industry leader in patient reported outcomes (PRO) solutions for clinical research, and Medidata Solutions, a global provider of electronic clinical data capture, management and reporting solutions, today announced the first integration of data from invivodata’s DiaryPRO™ handheld electronic patient diary with Medidata’s Rave™ electronic clinical data management platform. This solution is being used by Nabi Biopharmaceuticals in a Phase IIb proof-of-concept clinical trial for NicVAX, a vaccine candidate for nicotine addiction.
The companies’ integrated solution will enable PRO data captured on invivodata DiaryPRO and Case Report Form (CRF) data captured on Medidata Rave to be viewed by clinical trial personnel in a single location. As a result, sponsors and sites will gain real-time access to a more comprehensive view of critical patient data captured from both systems within Medidata Rave. By simplifying access to what are typically disparate sources of electronically captured PRO and CRF patient data, site personnel are able to more easily and accurately use information from multiple sources to manage patients enrolled in their clinical study.
“invivodata and Medidata developed a solution that our investigative sites will use to efficiently monitor all patient-collected data throughout the trial,” said Henrik Rasmussen, M.D., Ph.D., senior vice president of clinical, medical and regulatory affairs at Nabi Biopharmaceuticals. “Our goal is to give clinical investigators tools that provide them with greater visibility into real-time patient information, so they can make more timely and effective decisions regarding patient safety.”
Bob Young, senior vice president of sales and marketing at invivodata, said, “By integrating our proven eDiary technology with Medidata’s user-friendly Rave electronic data capture (EDC), management and reporting system, we are enabling Nabi to conduct more efficient research and advance its development of safe and effective medical treatments.”
“Nabi’s leadership in leveraging a continuous feed of PRO data that is integrated into EDC highlights two key goals for any electronic clinical trial: obtain earlier insight into data, and provide real-world value to investigator sites. We are delighted to be working with them, making those goals a reality,” said Glen de Vries, chief technology officer at Medidata Solutions. “We look forward to continuing this productive collaboration with invivodata, and making the seamless integration of ePRO and EDC a standard.”
About invivodata inc.
invivodata (www.invivodata.com) combines behavioral science, information technology and clinical expertise to capture the highest-quality electronic patient reported outcomes (ePRO) data in clinical research. The invivodata solution, which includes DiaryPRO for real-time PRO data collection and SitePRO™ for site-based PRO data collection, is based on patented compliance methods that include a proven patient management system that gives researchers and sponsors visibility into study progress and improves trial efficiencies. Strengthened by its regulatory and scientific expertise, invivodata is the industry-leading eDiary provider for delivering primary efficacy data for FDA approvals. Its solutions have been used in 150 clinical trials worldwide by more than 60,000 patients, collecting over 89 million patient-initiated entries for studies in over 65 disease states. invivodata’s scalable business model enables it to satisfy diverse client needs and meet the increasing global demand for its innovative solutions. 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.
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 lifeenhancing treatments to market—on five continents and in more than 70 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 Nabi Biopharmaceuticals
Nabi Biopharmaceuticals leverages its experience and knowledge in powering the immune system to develop and market products that fight serious medical conditions. The company has three products on the market today: PhosLo® (calcium acetate), NabiHB® [Hepatitis B Immune Globulin (Human)], and Aloprim™ (allopurinol sodium) for Injection. Nabi Biopharmaceuticals is focused on developing products that address unmet medical needs and offer commercial opportunities in our core business areas: hepatitis and transplant, kidney disease (nephrology) gram-positive bacterial infections and nicotine addiction. For a complete list of pipeline products, please go to: http://www.nabi.com/pipeline/index.php. The company is headquartered in Boca Raton, Florida. For additional information about Nabi Biopharmaceuticals, please visit our website: http://www.nabi.com.
Contact:
Susan Lombardo
Lois Paul & Partners
781.782.5767
Susan_Lombardo@lpp.com