ArisGlobal Announces Enhanced Global Trial Disclosure and Compliance Solution
ArisGlobal, a provider of solutions to the life sciences industry, has announced agDisclosure™ 3.1, a system that enables sponsors to plan, prepare and manage submissions to multiple registries. 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,” commented 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.
FDA Grants Priority Review to Merck’s sBLA for Winrevair After Early Success in ZENITH PAH Trial
July 2nd 2025Merck’s bid to update Winrevair’s label advances with FDA priority review, backed by Phase III ZENITH data showing a 76% reduction in major morbidity and mortality events in patients with pulmonary arterial hypertension.
Unifying Industry to Better Understand GCP Guidance
May 7th 2025In this episode of the Applied Clinical Trials Podcast, David Nickerson, head of clinical quality management at EMD Serono; and Arlene Lee, director of product management, data quality & risk management solutions at Medidata, discuss the newest ICH E6(R3) GCP guidelines as well as how TransCelerate and ACRO have partnered to help stakeholders better acclimate to these guidelines.
Phase III PROMINENT Trial Initiated to Evaluate Felzartamab for Primary Membranous Nephropathy
June 30th 2025The global Phase III PROMINENT trial has begun dosing patients to evaluate felzartamab in treating primary membranous nephropathy, a serious autoimmune kidney disorder with no FDA-approved therapies.
Putting Collective Insights Into Action to Advance Cancer Care: Key Examples From ASCO 2025
June 27th 2025At ASCO 2025, clinical operations leaders gained critical insights into how AI tools, bispecific antibodies, and evolving treatment paradigms are reshaping trial design, endpoint selection, and patient stratification.
