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Tools for Clinical Trials Professionals
Cytel's (Cambridge, MA) major new suite of clinical trial design, simulation, and monitoring software gives investigators and sponsors unprecedented flexibility in conducting clinical trials. The new release significantly expands the capabilities of East software with broad coverage of numerous one-, two- and K-sample designs, new graphical displays, new simulation tools to handle time-to-event trials in realistic settings, and a slew of other adaptive tools—all fully validated for regulatory purposes.
By using complex statistical and mathematical methodologies, East 4 can address an extended set of design problems. Say you need to compare different trial designs—with East 4 it's not only possible to optimize designs side by side, but you can also calculate and adjust sample size and stopping boundaries (including user-specified spending functions), or examine design properties with interactive repeated confidence intervals. And all of this is accomplished through a rich user interface that can link with the MS Office 2000 environment, including Excel.
The new EastSurv and EastAdapt modules allow customization through adaptive design or in nonuniform patient enrollment situations.
Cytel Inc., 617-661-2011, http://www.cytel.com
Versatility, clinical validation, security protection...these are among the host of features offered by SunTech Medical's (Morrisville, NC) Oscar 2 ambulatory blood pressure monitor and the Oscar Express transtelephonic ABP system.
Oscar 2 comes with an A/A rating from the British Hypertension Society and full compliance to the ESH International Protocol, as well as to AAMI/SP10 standards (the highest level of clinical validation). Backed by a standard 2-year or an available 5-year warranty, the system offers password protection to prevent unauthorized access to data. And if you've ever wished technology could be just a little easier to implement, Oscar 2's plug-and-play modem means reduced setup time and cost.
As a bonus, these monitors incorporate leading-edge motion tolerance technology, enabling better data collection and patient comfort. And data can be exported in ASCII format (using familiar Flash storage media) for seamless integration into most software.
The icing on the cake is the top-notch support, which begins with onsite training by SunTech Medical's support personnel and includes phone access to friendly, knowledgeable staff.
SunTech Medical, 800-421-8626, http://www.suntechmed.com/oscar2.htm
With a recent compliance audit by Yamatake Corporation behind it, the Moss Institute's (Tokyo, Japan) CLASSY EDC system can bill itself fully compliant with FDA's Part 11 of Title 21 of the Code of Federal Regulations. CLASSY EDC accelerates data capture, improves quality, and reduces the cost of clinical trials by fully supporting data collection, management, and statistical analysis.
The system was designed to provide service tailored to the needs of users at different stages of research, with each protocol designed specifically to the individual client. And where ease of use at medical institutions is concerned, MOSS is able to provide robust support either on the Web or by phone, and promises to provide assistance during every stage of data management. Too, the company performs server maintenance and has built robust security features into the software.
Labs can query data servers by email or cell phone, so that, in essence, the software replaces handwritten CRF papers. Basic functions include preview, data check, query management, safety information, progress reports, and data that converts to CDMS.
Moss Institute, +81-3-5623-7207, http://www.moss.co.jp/english