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.
"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 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, Ohio. "It's obvious, careful review and planning went into the development of this EDC by people doing quality clinical research."
Davis Templeton, CMO, is leading commercialization efforts for Guardian EDC(TM) and can be reached at firstname.lastname@example.org or 720-304-6536. Guardian EDC(TM) will also be demonstrated at the upcoming DIA annual meeting in Boston, June 22-26.
Accelerated Community Oncology Research Network, Inc. (ACORN)
ACORN focuses on oncology exclusively. ACORN offers centralized
clinical trial services, scientific analysis, and is a full-service
Clinical Research Organization (CRO), providing contract and budgeting
services; fostering accrual of subjects at the site level; collecting data
and monitoring its accuracy; and working seamlessly with both trial
sponsors and participating practices.
Deborah D. Coble
|SOURCE Accelerated Community Oncology Research Network|
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