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We are proud to announce the official release of version 6.1 of our Promasys Clinical Trial Data Management and Workflow Support software.x
Version 6.1 brings important new features to our users: the WebCRF and electronic signatures.
The WebCRF
The WebCRF is Promasys' own EDC system. It is an additional module to the Promasys core application. It provides access to the Promasys database for data entry and data management tasks through a standard web browser. On the client side, no software installation is required. This makes the WebCRF an ideal platform for multi-center studies.
Users with suitable access rights are able to enroll new subjects and perform data entry tasks. The wealth of data entry support functions of the main interface are also available in the WebCRF: data types, code lists, units, input formats, confirmation and refusal limits, etc. Data managers can view the data -including notes and the history of the individual data items (from the audit trail)- and issue queries and perform query management tasks.
Similar to the paper CRFs and the data entry screens in the native interface, the screens of the WebCRF are automatically generated from the clinical study database design. So there is never a discrepancy between the data collection screens and the database. Changes in the design, e.g. resulting from a protocol amendment, are automatically and consistently implemented in all screens and forms. Access to the system is controlled by robust business logic at the server level. Your data remains fully protected, whether you work in the native interface or through the WebCRF.
While the native Promasys interface is available only in English, the interface of the WebCRF can easily be made available in local languages.
Electronic Signatures
The new Electronic Signatures functionality of Promasys allows authorized users to sign off data for review (e.g. by the data manager) and for approval (e.g. by the Principal Investigator). Data can be signed individually or in batch mode (e.g. per subject visit). The responsibility to sign for AE’s and Conmeds can be assigned separately (e.g. to a physician). While Electronic Signatures are particularly relevant for EDC based trials, Promasys will continue to fully support paper CRF based trials, and in fact is ideal for managing hybrid trials, as during the design phase of the trial it can be indicated for each individual variable whether or not dual entry is required (typically required for paper CRF data) and whether or not electronic signatures for review and/or approval are required. This allows for maximum flexibility, and at the same time enables our users to fully comply with the strictest rules and requirements
The Electronic Signatures functionality of Promasys version 6.1 is fully compliant with 21 CFR part 11. |