ArisGlobal, a provider of integrated software solutions for pharmacovigilance and safety, regulatory affairs, clinical research and medical information, has launched agDisclosure 3.1, a comprehensive system that enables sponsors to plan, prepare and manage submissions to multiple registries with ease. 

agDisclosure is the newest addition to ArisGlobal’s Total Clinical, a comprehensive platform for clinical research that includes EDC, CTMS, ePRO, medical coding, supply chain management and safety reporting—all accessed via agWorld, a central clinical portal.

“Clinical trial transparency is an established expectation today and this is being reinforced by regulation in many parts of the world,” said Mathias Poensgen, product manager at ArisGlobal. “There are many registries and each requires differing data sets with unique business rules based on local regulation. Until standardization is achieved, the entire disclosure process will remain complex. With agDisclosure, sponsors can manage all disclosure activity from a single platform, reusing data sets multiple times while reports, metrics and dashboards give users insight into the worldwide status of their registries.”

agDisclosure is fully 21 CFR Part 11 compliant and provides built-in support for multiple trial registries, including ClinicalTrials.gov and EudraCT.  Users can generate and review datasets, run validation checks and create submission-ready XML files for upload.  Key features include:

• Out-of-the-box validation rules.
• Flexible database structure with business rules adaptable to future registry requirements and new fields added without coding efforts.
• Import of data from any CTMS, including ArisGlobal’s agClinical.

Configurable workflow capabilities support the data review and approval process required for submission while allowing multiple review cycles from different reviewers. Once approved, applicable submission sets can be created with appropriate registry-specific validations applied to ensure the integrity of the submission process. Necessary trial updates can also be submitted to the respective trial registry.

agDisclosure 3.1 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.