13.12.2006 14:00:00
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Dana-Farber/Harvard Cancer Center Implements Phase Forward's Electronic Data Capture Product for Pediatric Leukemia Study
Phase Forward (NASDAQ: PFWD), a leading provider of data management solutions for clinical trials and drug safety, today announced that the Dana-Farber/Harvard Cancer Center (DF/HCC) has implemented Phase Forward’s InForm™ Electronic Data Capture (EDC) product for a 500-subject pediatric acute lymphoblastic leukemia (ALL) study. The DF/HCC, launched in 1999 and supported in 2000 by a Cancer Center Support Grant from the National Cancer Institute (NCI) as a NCI-designated Comprehensive Cancer Center, is the largest cancer center in the U.S., with more than 900 faculty-level scientists performing clinical, basic and population research. Dana-Farber Cancer Institute is the administrative center of the DF/HCC, which runs approximately 150 investigator-initiated oncology studies at any time, and can have upwards of 450 active studies. These trials test many types of treatments, such as new agents, vaccines, new approaches to surgery or radiation therapy, or new combinations of existing treatments for the different kinds of cancer seen in DF/HCC and affiliated hospitals. Since standardizing on the InForm product in 2005, DF/HCC has implemented more than a dozen studies using the system. The pediatric ALL study is the largest study undertaken to date at DF/HCC using InForm. Pediatric ALL, a malignant disease of the bone marrow, is the most common form of childhood cancer. The study is designed to both improve survival rates and minimize toxicities associated with therapy. To date, more than 140 patients have been enrolled in the study, which will ultimately involve more than 500 patients at nine centers in Canada, Puerto Rico and the U.S. When the study began in 2005, data was captured on paper. The DF/HCC team wanted to gain experience with smaller studies using the InForm EDC product before stepping up to this larger, distributed study. "We are pleased to have converted this study to EDC and are beginning to derive the benefits of InForm, such as greater data visibility earlier in the trial and more accurate data resulting from the edit checks that begin at the data entry stage,” said Jane O’Brien, CCRP, pediatric ALL program manager. "We also value the ability to quickly generate ad hoc reports and to quickly resolve queries.” "Dana-Farber/Harvard Cancer Center is one of the most respected research institutions in the world, and we’re honored to serve as a strategic partner,” said Bob Weiler, president and chief executive of Phase Forward. "It’s no surprise that the rigor and organization that this top-notch team brought to the evaluation process has been translated into a smooth and productive ramp up over this first year.” Path to Success DF/HCC has more than 400 oncology clinical investigators conducting 133 principal investigator-initiated trials in 2006. The organization handles thousands of case report forms per year, according to Marina Nillni, EDC implementation program manager at DF/HCC. DF/HCC selected the InForm product after a rigorous evaluation process that measured 12 vendors against 173 weighted criteria, according to Nillni. Key factors included reduced data entry through systems integration, upfront edit checks and improved turnaround for study analysis and reporting. The team evaluated product architecture to ensure that it could scale and be supported easily. DF/HCC also created a category called "business criteria” that measured the vendor’s stability, depth and breadth of services, responsiveness and general ability of DF/HCC and the vendor to work together. Nillni reports that key benefits to date of using InForm include: Reducing the time to get data from a study from four weeks with the paper-based system to real-time, which can help to accelerate the trial process. Decreasing the amount of time to resolve queries from weeks to hours. "Our expectations were extremely high, but the results have measured up,” said Nillni. "We implemented the InForm product on time and below budget while exceeding performance expectations.” About Dana-Farber/Harvard Cancer Center The Dana-Farber/Harvard Cancer Center (www.dfhcc.harvard.edu) is an inter-institutional research collaboration that unites the major clinical, population, and basic cancer research efforts of the Beth Israel Deaconess Medical Center, Brigham and Women’s Hospital, Children’s Hospital Boston, Dana-Farber Cancer Institute, Harvard Medical School, Harvard School of Public Health, and Massachusetts General Hospital. The DF/HCC formally became a National Cancer Institute-designated Comprehensive Cancer Center in 2000. About Phase Forward Phase Forward is a leading provider of integrated data management solutions for clinical trials and drug safety. The company offers proven solutions for electronic data capture (InForm™), clinical data management (Clintrial™), clinical trials signal detection (CTSD™), strategic pharmacovigilance (WebVDME™ and Signal Management), adverse event reporting (Clintrace™) and applied data standards (WebSDM™). In addition, the company provides services in the areas of application implementation, hosting and validation, data integration, business process optimization, safety data management and industry standards. Phase Forward’s products and services have been utilized in over 10,000 clinical trials involving more than 1,000,000 clinical trial study participants at over 260 organizations and regulatory agencies worldwide including: AstraZeneca, Boston Scientific, Dana-Farber Cancer Institute, Eli Lilly, Food and Drug Administration, GlaxoSmithKline, Merck, U.K. Medicines and Healthcare Products Regulatory Agency, National Institutes of Health, Procter & Gamble, Quintiles, sanofi-aventis, Schering-Plough Research Institute, Serono and Servier. Additional information about Phase Forward is available at www.phaseforward.com. Certain statements made in this press release that are not based on historical information are forward-looking statements which are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. This press release contains express or implied forward-looking statements relating to, among other things, the performance and features of Phase Forward’s products and services, demand for Phase Forward’s products and services, future business and operations plans of a Phase Forward customer, and the ability of Phase Forward’s customers to realize benefits from the use of Phase Forward’s products and services. These statements are neither promises nor guarantees, but are subject to a variety of risks and uncertainties, many of which are beyond Phase Forward's control, which could cause actual results to differ materially from those contemplated in these forward-looking statements. In particular, the risks and uncertainties include, among other things, the ability of Phase Forward’s customers to realize benefits from the use of its products and services, the possibility that customers’ needs or plans may change over time, and the possibility that the level of demand for Phase Forward’s products and services may vary. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. Phase Forward undertakes no obligation to update or revise the information contained in this press release, whether as a result of new information, future events or circumstances or otherwise. For additional disclosure regarding these and other risks faced by Phase Forward, see the disclosure contained in Phase Forward's public filings with the Securities and Exchange Commission including, without limitation, its most recent Quarterly Report on Form 10-Q.
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