The current approaches to remote subject review using review of eCRF pages has many disadvantages and limitations. By looking at data by data set and by visit in the CRF alone, data and process errors affect subject safety are easily missed. Another limitation of current review approaches: all data are considered the same; equal time and effort is spent on every data point.
MANA RBM’s proprietary SPARTM eliminates those problems and pioneers a new comprehensive approach to critical data review. It synthesizes data across multiple data sets and data sources, normalized to treatment day.
SPARTM provides a unique data visualization of high-risk data elements and processes (e.g., those affecting subject safety, protocol compliance, and data integrity) identified during the Risk Assessment process. SPAR helps monitors, data managers, and medical monitors see the entire picture of a subject’s progress in the trial—allowing context across data sets within a visit and across visits.
Monitors, data managers, and medical monitors describe SPARTM as invaluable in identifying trends not evident using traditional monitoring approaches. MANA RBM published a paper describing the 99% time savings achieved using the SPARTM for subject review compared to remote eCRF for subject review: Link
An example of a Subject Profile Analyzing Risk showing a combination of data from the clinical database, subject diary, and dosing data for fast, efficient oversight.