MongoTrials

MongoTrials is an open-source software platform designed to manage clinical trial data using a document-oriented approach built on MongoDB technologies. It provides data modeling, secure storage, and workflow management for trial operations.

The platform uses MongoDB as the primary datastore, organizing study metadata, participant records, visits, labs, and adverse events into flexible collections. It supports JSON Schema validation, encryption at rest, and field-level access controls, with end-to-end audit trails. An API layer offers REST and optional GraphQL access, and the system supports multi-tenant deployment and sharding for scalability.

Core features include study templates, case report forms, data import and export utilities, de-identification workflows, versioning of records, and complete provenance tracking. Built-in dashboards provide data quality metrics and progress indicators, while integrations with statistical tools support interim analyses and regulatory reporting.

Typical use involves designing trials, collecting and curating data at multiple sites, monitoring safety and compliance, and generating audit-ready datasets for sponsors and regulators. The project emphasizes governance, privacy, and reproducibility, and aims to reduce the time from trial initiation to analytics.

Development and licensing: MongoTrials is maintained by a community of contributors and released under an open-source license. Documentation, installation guides, and API references are available on the project’s website and code repository.