Streamlining and increasing the efficiency in the clinical data management, data capture and reporting process are cornerstones of Promasys. From end to end, Promasys was developed to increase the speed of study start-up and data capture, while virtually eliminating the need for IT or programming skills. Promasys is focused on ensuring high data integrity and quality-controlled clinical trial conduct.
Promasys features an innovative iPad-compatible EDC that brings secure mobile data entry and subject management to the clinical trials work floor. The Promasys iPad app delivers Promasys’s featured support for data quality, integrity and regulatory compliance on a mobile device, making it easier for research nurses and study investigators to enter and review data while at the point of care. Efficiency and error prevention are further increased by the barcode based navigation that takes the user immediately to the subject and CRF that are to be data entered. Study monitors also benefit from the mobile capability of the Promasys iPad app: when doing source document verification tasks at the study site, they can review the data in the database (with read-only access), look at the audit trail information of data items, raise and review queries, and sign off data for review.
Promasys 7.3 brings integrated ePro to the game. The Promasys ePRO Configurator allows the study designer to select a subset of data items for subject/patient direct data entry, and to enhance these data items with special attributes to make them suitable for ePRO use, like data entry time windows, notifications and use of onboard hardware such as camera, etc. Once the ePRO configuration for a study is complete and the ePRO study is published, study participants can download an (automatically generated) study-specific app to their iOS or Android device and after authentication will be guided by the app to enter information as required by the study protocol. The data itself is part of the overall study data and is subject to the same data quality requirements and checks. There is no need for consolidation between a study database and an ePro generated dataset. ePRO data is available to the study coordinators in real time.