ACORN Expands Presence in EDC Market with Commercialization of Guardi...( MEMPHIS Tenn. May 14 /- Accelerat...),Health

MEMPHIS, Tenn., May 14 /PRNewswire/ -- Accelerated Community Oncology Research Network(TM) (ACORN), an oncology-focused CRO and research network, announced today that it is making its Electronic Data Capture (EDC) system, Guardian EDC(TM), commercially available. This proprietary system will be available for all studies, including those outside of oncology. Previously, Guardian EDC (TM) has only been available to studies within the ACORN clinical trial portfolio.

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"Since its deployment, the web-based Guardian EDC(TM) has been used in multiple industry-sponsored trials, investigator initiated trials, and large observational trials," according to Ed Stepanski, Chief Operating Officer. "We believe Guardian provides an extremely secure, functional, and economically attractive EDC alternative to pharmaceutical sponsors and CROs in both oncology and other medical specialties."

Guardian EDC(TM) satisfies and or surpasses all applicable FDA regulations, including 21 CFR Part 11. Among its more significant features are automatic randomization; full on-screen audit trail capability, providing user identification, date, time and reason for edit; auto-generating reports; and electronic principal investigator signatures. For convenience, Guardian EDC(TM) provides extensive study amendment capabilities.

"In the development process we analyzed the strengths and weaknesses of all the EDCs our network worked with over the last 5 years," according to Bridget Rose, Guardian EDC(TM) Project Leader. "We then designed a system which meets the demanding needs of oncology clinical research and are quite pleased with the end product. Guardian has proven to be a critical component of our successful clinical trial program."

Guardian EDC(TM) enhances study efficiencies for both industry sponsors and partici
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