TrialDisclose is a software product that is designed to automate the submission of clinical trials and their results data to clinicaltrials.gov, EudraCT and other registries. It enables compliance, data consistency and re-use of trial disclosure data across multiple registries.
TrialDisclose is a cloud based platform for comprehensive and compliant global clinical trial disclosure, helping regulatory affairs professionals to efficiently plan and execute their disclosure activities:
Supports the end to end process of data collection, review, registry specific validations and generating requisite electronic files for upload to the registry.
Supports Compliance with Global Serialization & Pedigree Regulatory Mandates.
Completely eliminates error-prone manual methods with automated processes and content re-use to dramatically improve productivity and accuracy.
Enables you to meet evolving changing regulatory disclosure requirements with USA, EU and other global agencies.
Enables unsurpassed efficiency, consistency and predictability.
Remain fully compliant with current and evolving clinical trial disclosure regulations.
Ready to deploy integration adapters with source data systems like EDC, CTMS, SAS data sets and spreadsheets.
How it is Delivered
Our professional services team consists of domain experts who possess full knowledge of clinical trial disclosure requirements related to FDA, EudraCT shall help manage the overall TrialDisclose solution deployment activities. Our services include:
Solution design activities including business/functional requirement analysis, solution strategy, solution design.
System integration services using accelerators to deliver implementation, validation, upgrade, project management, data/systems migration, end user training.
Fully managed regulatory compliant cloud hosting.
- Analysis of source systems, implement and build custom adapters to automate source data import in to TrialDisclose solution.
Remote service desk and application support.
- 99.9% availability
- Service Desk