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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 & NEW YORK New York, state, United States
New York, Middle Atlantic state of the United States. It is bordered by Vermont, Massachusetts, Connecticut, and the Atlantic Ocean (E), New Jersey and Pennsylvania (S), Lakes Erie and Ontario and the Canadian province of
 -- invivodata(R) 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(TM) handheld electronic patient diary with Medidata's Rave(TM) 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 CRF
abbr.
chronic renal failure


CRF Chronic renal failure
) 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 EDC

See: Export Development Corp.
), 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 de Vries. For some persons thus named use 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(TM) 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 FDA
abbr.
Food and Drug Administration


FDA,
n.pr See Food and Drug Administration.

FDA,
n.pr the abbreviation for the Food and Drug Administration.
 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 privately held company

A firm whose shares are held within a relatively small circle of owners and are not traded publicly.
 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 life-enhancing 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 immune system

Cells, cell products, organs, and structures of the body involved in the detection and destruction of foreign invaders, such as bacteria, viruses, and cancer cells. Immunity is based on the system's ability to launch a defense against such invaders.
 to develop and market products that fight serious medical conditions. The company has three products on the market today: PhosLo(R) (calcium acetate calcium acetate

Phos-Ex (UK), PhosLo, PhosLo Gelcap

Pharmacologic class: Mineral

Therapeutic class: Dietary supplement, electrolyte replacement agent

Pregnancy risk category C
), Nabi-HB(R) (Hepatitis B Hepatitis B Definition

Hepatitis B is a potentially serious form of liver inflammation due to infection by the hepatitis B virus (HBV). It occurs in both rapidly developing (acute) and long-lasting (chronic) forms, and is one of the most common chronic
 Immune Globulin Immune globulin
Serum containing antibodies against a specific infection.

Mentioned in: Maternal to Fetal Infections
 (Human)), and Aloprim(TM) (allopurinol sodium allopurinol sodium

Aloprim

Pharmacologic class: Xanthine oxidase inhibitor

Therapeutic class: Antigout drug

Pregnancy risk category C

Action

) 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 Kidney Disease Definition

Kidney disease is a general term for any damage that reduces the functioning of the kidney. Kidney disease is also called renal disease.
 (nephrology nephrology

Branch of medicine dealing with kidney function and diseases. An understanding of kidney physiology is important not only in treating kidney disease but in knowing the effect of drugs, diet, and hypertension on kidney disease, and vice versa.
) 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 Boca Raton ("bōkə rə-tōn") is a city in Palm Beach County, Florida incorporated in May 1925. As of the 2000 census, the city had a total population of 74,764; the 2006 population recorded by the U.S. Census Bureau was 86,396. . For additional information about Nabi Biopharmaceuticals, please visit our website: http://www.nabi.com.
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Copyright 2006, Gale Group. All rights reserved. Gale Group is a Thomson Corporation Company.

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Publication:Business Wire
Article Type:Company overview
Date:Aug 29, 2006
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