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ACORN expands market presence with commercialization of Guardian EDCT, the company’s electronic data capture system.
Memphis, TN-May 14, 2008-Accelerated Community Oncology Research Network (ACORN), an oncology-focused CRO and research network, announced today that it is making its Electronic Data Capture (EDC) system, Guardian EDCT, commercially available. This proprietary system will be available for all studies, including those outside of oncology. Previously, Guardian EDCT has only been available to studies within the ACORN clinical trial portfolio.
"Since its deployment, the web-based Guardian EDCT 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 EDCT 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 EDCT 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 five years", according to Bridget Rose, Guardian EDCT 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 EDCT enhances study efficiencies for both industry sponsors and participating practices. It places study information at the fingertips of users in one centralized location with the ability to drill down to minute detail. User-friendly, intuitive navigation virtually eliminates any learning curve and has been responsible for high user acceptance ratings.
"Having experience with multiple systems, we have found Guardian to be the most straightforward, user friendly EDC our practice has used," according to Lynn Kaplan, research coordinator with Tri-County Hematology & Oncology Associates in Canton, OH. "It's obvious, careful review and planning went into the development of this EDC by people doing quality clinical research."