CONSORTPRO

CONSORTPRO is a software platform and guideline framework designed to streamline the planning, execution, and reporting of clinical trials. It blends methodological guidance with digital tooling intended to improve transparency, efficiency, and regulatory compliance.

The platform typically includes modules for protocol development, trial registration and scheduling, data collection and validation, statistical analysis planning, and standardized trial reports. It guides users through the CONSORT reporting requirements during manuscript preparation and enables automated generation of tables and figures.

Interoperability and standards: CONSORTPRO supports common data standards used in clinical research, such as CDISC and HL7, and can exchange data with electronic data capture systems, central laboratories, and regulatory submission portals. It maintains an auditable history of changes and enforces role-based access control.

Development and governance: The project is developed by a consortium of academic institutions, industry partners, and professional societies. It emphasizes open guidelines and provides configurable templates for various trial types, including parallel, crossover, and adaptive designs.

Reception and use: Institutions report improved trial documentation quality, faster manuscript preparation, and better alignment with CONSORT guidelines. Critics note that implementation requires training and ongoing licensing costs; some also call for greater flexibility for non-traditional trial designs.

See also CONSORT guidelines.