Clinical-Trials Company Improves Reliability and Reduces Trial Costs Using Handhelds to Capture Patient Data Wirelessly.SUNNYVALE, Calif. -- invivodata First to Implement Palm TX Handhelds in Clinical Trials, Letting Patients Securely Log Data from Wireless Locations Worldwide Palm, Inc. (Nasdaq:PALM) and invivodata(R) Inc., are helping clinical-trial sponsors capture more reliable Patient Reported Outcomes (PRO) data and reduce drug-development costs by giving patients better tools for sharing information about their experiences during clinical trials. invivodata, a leader in electronic Patient Reported Outcomes (ePRO) solutions for global clinical research, has standardized standardized pertaining to data that have been submitted to standardization procedures. standardized morbidity rate see morbidity rate. standardized mortality rate see mortality rate. on the Palm(R) TX handheld, coupled with invivodata's wireless modem A modem and antenna that transmits and receives over the air. Wireless modems support several technologies, including 802.11, Bluetooth, CDPD, DataTAC, Mobitex and Ricochet. There are wireless modems for laptops, handhelds and cellphones. cradle, for use in clinical trials. The global wireless ePRO solution, available only from invivodata, already is being used by more than 600 patients in two clinical trials across Europe and North America North America, third largest continent (1990 est. pop. 365,000,000), c.9,400,000 sq mi (24,346,000 sq km), the northern of the two continents of the Western Hemisphere. . With DiaryPRO(R), invivodata's market-leading global ePRO solution, clinical-trial sponsors can collect PRO data more reliably and efficiently from anywhere in the world where wireless access is available. Patients also benefit from the Palm TX handheld's larger, higher-resolution, 320x480 color screen, which is easy to read and allows for more comprehensive assessments than most handheld screens on the market. "Clinical trials are an essential step in bringing important life-saving drugs to market. With the improvements in reliability and accuracy of PRO data delivered by invivodata, pharmaceutical and medical device companies can gain competitive advantage and bring a drug to market more efficiently," said Tara Griffin, vice president of enterprise markets, Palm, Inc. "invivodata's ePRO solution, based on the Palm TX handheld, is very patient-friendly, delivering a superior mobile experience for trial participants and valuable data for investigators." When conducting worldwide clinical trials, most sponsors patch together a mix of wired and unwired Unwired is an Australian public company dedicated to building a nationwide, fixed wireless telecommunications network offering carrier grade Internet services. They currently provide coverage in Sydney and Melbourne. electronic diary (eDiary) devices that vary in screen size, functionality, cost, development and reliability. Such solutions can be expensive because they require multiple versions of hardware, software, and training and help-desk materials. Additionally, trial sponsors may have to modify questionnaires to fit varying kinds of eDiary screens, which would require the sponsor to demonstrate that patients interpret the questions uniformly, in order to reduce regulatory risk. "With the Palm TX handheld and our wireless modem cradle, our clients can benefit from more reliable and valid PRO data, without the worry of costly inconsistencies among multiple eDiary devices," said Doug Engfer, founder, president and chief executive officer of invivodata. "The solution is also well-suited for patients. Elderly patients in particular appreciate the larger screen size, easy-to-use interface and ample battery life, making the Palm TX a superior choice." A 312MHz (MegaHertZ) One million cycles per second. It is used to measure the transmission speed of electronic devices, including channels, buses and the computer's internal clock. A one-megahertz clock (1 MHz) means some number of bits (16, 32, 64, etc. processor gives patients the ability to enter large volumes of highly detailed data without losing speed or power. The Palm TX handheld's 128MB flash memory helps protect data, and the screen rotates for portrait or landscape viewing. Wireless technology provides patients with functionality to upload clinical trial data automatically and seamlessly, and built-in Bluetooth(R) technology supports invivodata's SyncPro(TM) architecture to allow integration with physiological data monitors, measuring such factors as blood-glucose levels or respiratory peak-flow volumes.(1) The Palm TX handheld has an estimated U.S. street price of $299 and is available now from the Palm online store (http://store.palm.com), at Palm Retail Stores and at select retailers and resellers throughout the world. More information about Palm healthcare solutions is available at www.palm.com/healthcare or by calling 1-888-223-4817. About invivodata Inc. invivodata combines behavioral science behavioral science n. A scientific discipline, such as sociology, anthropology, or psychology, in which the actions and reactions of humans and animals are studied through observational and experimental methods. , information technology and clinical expertise to capture the highest-quality electronic Patient Reported Outcome (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 which 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 140 clinical trials worldwide by more than 55,000 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 Palm, Inc. Palm, Inc., a leader in mobile computing Using a computing device while in transit. Mobile computing implies wireless transmission, but wireless transmission does not necessarily imply mobile computing. Fixed wireless applications use satellites, radio systems and lasers to transmit between permanent objects such as buildings , strives to put the power of computing computing - computer in people's hands so they can access and share their most important information. The company's products for consumers, mobile professionals and businesses include Palm(R) Treo(TM) smartphones, Palm handheld computers A computing device that can be easily held in one hand while the other hand is used to operate it. The Palm devices are a popular example. See Palm, smartphone and palmtop. , and Palm LifeDrive(TM) mobile managers, as well as software, services and accessories. Palm products are sold through select Internet, retail, reseller An organization that sells hardware and software to the general public. Resellers purchase products from software publishers and hardware manufacturers. and wireless operator channels throughout the world, and at Palm Retail Stores and Palm online stores (http://www.palm.com/store). More information about Palm, Inc. is available at http://www.palm.com. (1) Works within wireless service coverage area only. An Internet service provider Internet service provider (ISP) Company that provides Internet connections and services to individuals and organizations. For a monthly fee, ISPs provide computer users with a connection to their site (see data transmission), as well as a log-in name and password. account, email account email account email n → compte m (e-)mail and subscription may be required for Internet and email access. These services may need to be purchased separately and additional charges may apply. Access via Bluetooth technology requires compatible GSM (Global System for Mobile Communications) A digital cellular phone technology based on TDMA that is the predominant system in Europe, but also used worldwide. Developed in the 1980s, GSM was first deployed in seven European countries in 1992. mobile phone with Bluetooth wireless technology, data service from a mobile service provider and ISP (1) See in-system programmable. (2) (Internet Service Provider) An organization that provides access to the Internet. Connection to the user is provided via dial-up, ISDN, cable, DSL and T1/T3 lines. , sold separately. Palm, Treo and LifeDrive are among the trademarks or registered trademarks owned by or licensed to Palm, Inc. All other brand and product names are or may be trademarks of, and are used to identify products or services of, their respective owners. |
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