MANA RBM’s proprietary STAR database provides Sponsors and CROs with a flexible tool customized to conduct your specific trial.
The STAR database captures critical, new data required for a total quality management approach including Risk Assessment, and CAPA oversight.
STAR 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.
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 STAR 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 all aspects of the STAR database incorporated into MANA RBM Custom Reports for Remote Trial Oversight (MANA Method). All aspects of clinical trial management, except the clinical data and third party vendor data, are incorporated into the STAR database.
MANA RBM deploys the STAR database in the same clinical system as the main database.
MANA RBM synthesizes data to focus on the critical data. This allows the study team to identify and correct issues rapidly. The graphic below explains the types of study-specific and operational reports used for each trial.