agDisclosure Now Supports Version 10 of the European Clinical Trials Database (EudraCT)

January 28, 2015
Applied Clinical Trials Editorial Staff

Applied Clinical Trials

ArisGlobal, a leading provider of solutions to the life sciences industry, has announced that agDisclosure, its clinical trial disclosure solution, now supports Version 10 of the European Medicines Agencys EudraCT database

STAMFORD, CT- January  28, 2015- ArisGlobal, a leading provider of solutions to the life sciences industry, has announced that agDisclosure, its clinical trial disclosure solution, now supports Version 10 of the European Medicines Agency’s EudraCT database (European Union Drug Regulating Authorities Clinical Trials).  EudraCT Version 10 makes the reporting of summary results mandatory to EudraCT, including those for legacy studies by July 2015 or July 2016, depending on the age of the trial. agDisclosure now supports reporting of results to both ClinicalTrials.gov and EudraCT, allowing customers to use ClinicalTrials.gov data and transform it to EudraCT data.

“Companies need to comply with the requirements from CT.GOV and EudraCT, both of which make results reporting mandatory,” stated Simon Sparkes, Executive Vice President, Product Strategy, ArisGlobal. “Consistency of the data published between different registries is another concern for many companies. agDisclosure provides a central area where protocol and results data sets are created for both CT.GOV and EudraCT. This approach, combined with automated workflow and approval routing ensures consistency of the data and allows users to register protocols and submit result data as efficiently as possible.”

agDisclosure supports the complete trial disclosure process – from gathering required data, reviews by stakeholders, conducting checks against registry-specific validation rules, to generating XML files for upload and automatic submission.  It is available to customers as a hosted solution via agOnDemand™, ArisGlobal's highly proven Software-as-a-Service (SaaS) delivery platform. A free version of agDisclosure is also available for ClinicalTrials.gov; interested companies can learn more by visiting http://totalclinical.com/agdisclosure-free-basic-edition.

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