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SAS in the Pharmaceutical Industry

SASВ® Software Powers Life-Saving New Process

Wireless devices aren’t just for storing telephone numbers anymore. Thanks to SAS e-Intelligence software and an innovative application from Synteract, the next person you see tapping a handheld Palm VII keypad could be saving someone’s life. SAS now provides on-the-spot wireless access to vital information that researchers are using to make critical decisions during clinical trials for an artificial liver device. In the process, some patients with acute liver failure are receiving quick access to the experimental treatment.

SAS and Synteract, a contract research organization headquartered near San Diego, are helping Vitagen, a La Jolla, Calif.-based biotechnology company, move its product through clinical trials. Synteract uses SAS to manage data for Vitagen’s artificial liver device, the Extracorporeal Liver Assist Device (ELAD) system. It contains live human liver cells and can perform a patient’s liver functions for up to 10 days. This extra time may keep a patient alive long enough for a donor organ to become available, or give a diseased liver time to heal. Every year, 14,000 people in the United States need liver transplants, but only 4,000 organs are available. This year, an estimated 1,400 patients will die waiting for a liver.

Vitagen is involved in a clinical trial to prove the safety and efficacy of the ELAD system. Since the device is considered experimental therapy, certain patients in the trial receive the ELAD system and others get a traditional treatment regimen. “We need to know on a minute-to-minute basis if the patient fits in the treatment arm or the control arm of the trial,” says Patrick Maguire, M.D., Vitagen’s vice president of medical affairs. “That lets people at our manufacturing site know what they need to ship to the hospital.”

This is where Synteract comes into the process. It houses Vitagen’s clinical trials data on a secure Web site, which Vitagen employees can access through a traditional Internet connection. However, by using a Palm VII application that surfaces SAS analysis of the trials, Vitagen also can access this data at any time via a wireless connection and run a program that randomly assigns patients in the clinical trial. Because the Palm VII is connected to the Internet, users can interact with the information. Previously, data stored on wireless handheld devices was static.

“Before we developed the Web and Palm applications, someone at Vitagen had to contact us by phone, fax or e-mail,” says Russell Holmes, chairman and vice president at Synteract. “Then we had to respond to the request. We were looking for a way to cut down this time. We’re talking about very sick people here. Every second counts.”

With its support for wireless applications, SAS was a natural choice. Using SAS software, developers at Synteract delivered an application in two days. “The power of SAS is its ability to deliver information that allows people to make decisions,” says Jim Davis, director of product strategy for SAS. “Wireless applications are simply another avenue for SAS to deliver information anywhere, any time.”

Maguire says he is glad that he doesn’t have to keep his laptop computer close by anymore. He can do his job anywhere as along as he has his Palm. “The patients we work with are critically ill,” he says. “It is absolutely mandatory that we get the right information to the right people at the right time.”

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