SAS, fabricante de software de Business Intelligence, y etrials Worldwide, fabricante de software para almacenar, integrar y analizar datos clínicos, han anunciado que proporcionarán conjuntamente una plataforma integrada para gestionar, analizar e investigar ensayos clínicos y datos operacionales. Actualmente está disponible en Norteamérica mediante una plataforma ASP.


CARY, N.C., June 8 — SAS, the leader in business intelligence, and etrials Worldwide Inc., a leading provider of software for the efficient collection, integration and review of clinical data, announced today that the two companies will jointly provide an integrated platform for pharmaceutical and biotechnology companies to capture, manage, analyze and explore clinical trial research and operational data. Available for North American customers today through an ASP platform, the joint offering will combine etrials’ proven, easy-to-use electronic data capture (EDC), electronic patient diary (EPD) and interactive voice response (IVR) software for entering data from clinical trials with SAS’ powerful clinical trials data integration and analysis solution.

Through this integrated platform, pharmaceutical, biotechnology and medical device companies will be able to take advantage of industry-leading software on either a per-trial or a multiyear subscription basis. As a result, life sciences firms will be able to complete trials more cost effectively; access cleaner, more complete research data; and perform safety, efficacy and other sophisticated analysis across their research programs without making substantial investments in computer hardware, software, consulting and maintenance.

«The pressure is on — life sciences firms are looking for ways to dramatically reduce the time and expense of drug development. The ability to integrate data from a variety of sources during clinical trials becomes a strategic differentiator,» said Carol Rozwell, Vice President and Research Director, Life Sciences for Gartner, Inc. «Pharmaceutical and biotech clients that want to get better answers to their clinical study questions — and get them more quickly — should look for tools that bundle information from multiple sources (e.g. IVR, electronic patient diary and electronic data capture tools) with tools for statistical modeling and predictive analysis.»

The joint platform dynamically integrates etrials’ QuickStudy EDC, EPD and IVR products with SAS(R) Drug Development, providing a fast, reliable method for collecting and securing clinical trials data into a powerful, integrated, back-end repository along with the statistical analysis software needed for real-time scrutiny. Customers using the SAS and etrials offering may be able to reduce their investments in expensive, legacy clinical data management systems (CDMS), allowing them to implement a comprehensive data strategy quickly across the enterprise that ensures compliance with 21 CFR Part 11. For companies implementing industry data standards, the combined SAS and etrials offering follows CDISC models for integrating disparate data sources.

«For organizations like The Medicines Company — whose business model is to acquire compounds in late stage development and take them to market — the ability to do comparative analysis across both archived and active studies is very important,» said Judy Sromovsky, director of development operations for The Medicines Company. «SAS and etrials are integrating the front-end data processes with the back-end analysis and warehousing. This allows study teams to review and analyze data in ways that just aren’t possible or cost-effective with traditional clinical data management systems. For example, the ability to monitor and predict trends across studies will help us better understand our product profile and plan for future studies. And the peace of mind of having all your study information housed and managed in a 21 CFR Part 11 compliant environment cannot be understated.»

etrials’ QuickStudy Capture is an easy-to-use electronic data capture system. A Web-based tool, QuickStudy Capture has a simple, secure interface that allows study sites to quickly learn how to enter patient data online. Monitors and sponsors can gain instant access to study data and, by implementing some minor process changes, can substantially increase the efficiency of the trial. etrials also offers QuickStudy Log, electronic handheld diary software for gathering compliant quality-of-life data from patients in clinical trials, and QuickStudy Voice, IVR software for randomizing, data collection, supply tracking and site management.

Within the life sciences research industries, SAS is the de facto standard for analyzing and reporting safety and efficacy during clinical trials. SAS Drug Development builds on this long history of success by helping customers integrate all of their research information, whether it has been captured via etrials’ leading technology solutions or other industry applications. With SAS Drug Development, customers analyze their research for regulatory submission and explore their research for new market opportunities, product line extensions and safety issues, all within a controlled and secure collaborative framework designed for life sciences research industries.

SAS and etrials will be showing the combined offering June 13-17 at the 40th annual meeting of the Drug Information Association (DIA) in Washington.

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