Support For EudraCT Results Reporting Is The Latest Enhancement To Aris Global, LLC’s Trial Disclosure Solution
agDisclosure Now Supports Version 10 of the European Clinical Trials Database (EudraCT), Providing Sponsors with the Ability to Upload Summary Results
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.
Connect with ArisGlobal:
•View the on-demand webinar, “EudraCT Results Reporting: Are You Sure You’re Ready?”
• Read the white paper on the same topic
• Join the discussion on our blog, Totally Clinical, where you can join the conversation on a wide range of clinical development topics, including this three-part series on the benefits of a unified solution
• Find us on LinkedIn
About ArisGlobal
For over 25 years ArisGlobal (www.arisglobal.com) has been 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.
Contacts
Kathy Capper
ArisGlobal
Tel + 44 (0) 1908 340 838
kcapper@arisglobal.com
Help employers find you! Check out all the jobs and post your resume.
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.
Connect with ArisGlobal:
•View the on-demand webinar, “EudraCT Results Reporting: Are You Sure You’re Ready?”
• Read the white paper on the same topic
• Join the discussion on our blog, Totally Clinical, where you can join the conversation on a wide range of clinical development topics, including this three-part series on the benefits of a unified solution
• Find us on LinkedIn
About ArisGlobal
For over 25 years ArisGlobal (www.arisglobal.com) has been 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.
Contacts
Kathy Capper
ArisGlobal
Tel + 44 (0) 1908 340 838
kcapper@arisglobal.com
Help employers find you! Check out all the jobs and post your resume.