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Aris Global, LLC Trial Disclosure Solution Helps Sponsors Report
11/20/2013 3:24:03 PM
New Release Now Offers New Functionality for Reporting Clinical Trial Results to Global Registries
STAMFORD, CT— November 20, 2013— Given the constant changes in the regulatory environment and the emergence of new trial registries, biopharma and medical device sponsors are challenged to meet trial disclosure requirements with a high degree of data consistency and quality. To help companies achieve an efficient disclosure process more easily, ArisGlobal has released an update to agDisclosure™ and its trial registry capabilities with new functionality that enables the reporting of study results across multiple registries through the re-use of approved data.
“For many companies faced with staff and budget limitations, trial registration and disclosure is a time and labor-intensive process that puts data consistency at risk,” stated Mathias Poensgen, product manager at ArisGlobal. “At the start of a trial high-level protocol information needs to be made available to clinicaltrials.gov, EudraCT or other registries. Once the trial is finished, basic information about the trial results has to be made available. agDisclosure supports both steps and enables users to enter data once for all registries rather than multiple times, ensuring data consistency.”
agDisclosure supports the complete process – from gathering required data, reviews by stakeholders, conducting checks against registry-specific validation rules, to generating XML files for upload and submission. It is available to customers as a licensed, on-premise solution or as a hosted solution via agOnDemand™, ArisGlobal's highly proven Software-as-a-Service (SaaS) delivery platform.
ArisGlobal (www.arisglobal.com) is a leading provider of integrated software solutions for pharmacovigilance and safety, regulatory affairs, clinical research and quality & compliance for medical inquiries. Solutions are available on premise or on a regulated cloud platform. Life science companies using ArisGlobal’s solutions can better build and maintain the trust they need with their customers, medical practitioners and regulatory bodies around the world.
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