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European Pharmaceutical Contractor

Increasing Trial Performance Through Replicated System Technology

Increasing use of EDC systems for trial data collection and management has heightened demand for access to the clinical trial database, as well as increasing our sensitivity to site connectivity and usability concerns.

Application replication technology greatly expands the available choices for deploying an EDC system, by simultaneously enhancing system response time and transparently providing centralised near real-time data availability, all the while assiduously assuring regulatory compliant data integrity. This technology facilitates a variety of user deployments including: enabling site monitors to work on their laptops while disconnected from the network and server; assuring appropriate response time for trials that include clinical sites distributed across multiple continents; and correctly supporting site-based electronic source data system configurations.

EDC systems are directly impacted by network delays. In our experience, a majority of sites across the globe are able to connect via the Internet at appropriate speeds for transactional systems. Nonetheless, for clinical sites that are in geographically remote or under-serviced network locations, or that are located within a large hospital, large clinic or pharmaceutical company with limited bandwidth access to the Internet, application replication technology can quickly and effectively accelerate system response time.


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By Eli Hauser, Executive Director Strategic Programs at Phase Forward Incorporated

Eli Hauser, Executive Director, Quality Assurance and Regulatory Compliance, brings more than 15 years of large systems integration program management experience to the company. Eli's background includes operating responsibility for product quality assurance, technical support, business process consulting and business systems implementation, as well as designing experimental high-speed radar circuitry.

He is an accomplished author and speaker, having shared his expertise in areas such as data centre risk management, EDC trial management metrics and EDC systems regulatory compliance, in many domestic and international forums. He earned a BSEE from Columbia University, an MA and MS from Northeastern University and received an MBA degree from New York University.

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