Global Trial Disclosure and Compliance
Greater transparency requirements have increased the workload for biopharmaceutical companies. Sponsors find it difficult to manage registrations worldwide given limitations in staff, budgets and with manual processes that are labor intensive. Constant changes in the regulatory environment and new emerging registries make it difficult to stay on top of current regulations.
agDisclosure™ enables life sciences organizations to efficiently manage registration of clinical trials to registries such as clinicaltrials.gov, EudraCT and other registries. It supports the complete process – from gathering required data, to review by stakeholders and conducting checks against registry specific validation rules and generating XML files for upload to the registry. agDisclosure helps companies to ensure compliance and consistency of data published in registries worldwide.
Superior, easy-to-use functionality
agDisclosure™ allows users to easily plan, prepare and submit registrations to registries such as clinicaltrials.gov and EudraCT. agDisclosure™ offers a single platform to manage all registrations worldwide, re-using the data entered once for multiple registrations. Workflow-driven review processes and built-in validation rules ensure high data quality. Via a subscription model, agDisclosure can be kept up to date with the newest versions of the major registries.
Other features include:
Out-of-box CTMS integration
Workflows for review
Tracking of review comments
Automatic generation of dataset according to registry specifications
Validation rules ensuring complete and accurate data
Automatic generation of XML files for upload to registries (e.g., clinicaltrials.gov) or submission (e.g., to European agencies (EudraCT))
Reuse of data across multiple registries
Reports and real-time metrics
Flexible database structure and business rules to adapt to future regulatory requirements (e.g., new fields can be added without coding efforts)
agDisclosure enables life science companies to ensure the compliance and consistency of data published in registries worldwide. Other benefits include:
Improves the planning and tracking of registrations
Provides an overview of worldwide registration status
Ensures compliance with global clinical trial registry regulations
Utilizes powerful workflows to easily manage the entire clinical trials disclosure process
Automatically updates with the newest versions of the registries
Delivers measurable cost savings through increased efficiency
Offers out-of-the-box integration with selected clinical systems
Provides built-in support for data requirements of all key registries, with the ability to easily configure for others