MANA RBM’s proprietary STARTM database provides Sponsors and CROs with a flexible tool customized to conduct your specific trial.
The STARTM database captures critical, new data required for a total quality management approach including Risk Assessment, Issue Management, and CAPA oversight.
STARTM enables electronic collection of documents traditionally maintained in paper at the research site (e.g., Delegation of Authority, Training Records), in Clinical Trial Management Systems (eMonitoring Reports and Monitoring Scheduling), and in trackers (Feasibility Questionnaires, Debarment Checks) for site selection and Medical Review.
Critical forms such as Deviations are also included with added levels of categorization to enable more efficient trending as part of central review.
Forms can be customized to protocol specifics (e.g., feasibility, training and delegation of authority). Access is also managed to enable granular access privileges to forms.
The STARTM database provides a robust tool for managing an individual trial AND it provides a valuable resource for planning and implementing future trials including data on Investigator Feasibility Responses and actual study conduct performance data.
The following figure shows many of the aspects of the STARTM database, a critical component of remote trial management.