Subject‑Level Clarity That Fuels Confident Decisions
Get an immediate, complete picture of each subject’s journey without piecing together disconnected data.
Spot meaningful shifts sooner with clear, time‑aligned patterns and anomalies.
Remove variability and strengthen quality with a standardised, audit‑ready review process.
Give medical monitors and reviewers the same contextual view so decisions are consistent and well‑informed.
All visits, AEs, labs and assessments displayed on a single, chronological timeline for instant clarity.
Every review action is captured automatically in a validated, inspection‑ready environment.
Ensure the right people see the right data with controlled, compliant user permissions.
Quickly view similar subjects side‑by‑side to sense‑check patterns without exporting data.
Availability of up-to-date risk scores
View evolution of risks over time
Centralized portal to collaborate with stakeholders
Customizable alerts
Customizable data visualizations
Eradicates duplication
Assign actions to stakeholders
Full discoverability of mitigations after closeout
Choosing the right oversight partner demands precision and clarity. We tackle your most common questions head-on, equipping you with the insights you need to make confident, informed decisions.
We are just starting to implement on real world trials, but from the process analysis we’ve seen we are expecting a 60-70% reduction in the time required to complete monitoring oversight and medical review.
The movement from desktop / spreadsheet listing review to a centralized, RBQM approach is always going to be a change management challenge, as we are asking people to think critically and prioritise effort and resources based on risk. The removal of admin and overlap or gaps is a positive step, and companies are glad to be moving to a GCP compliant approach rather than knowingly acting in a non-compliant manner.
We have a separate QTL module which can be used to compliment Subject Monitoring if desired.
This is an arbitrary number as an example for the demo, and not statistically or medically determined. We are just showing how the tool can be used, but not giving a specific approach for a given protocol.
This is not a CSM tool. We are looking at KRIs and KPIs at a subject level and determining specific risk factors based on the protocol to determine risk levels and prioritise review.
We can cater for multiple treatment arms and assessment schedules, the tool is inherently flexible and designed to support all trial designs. The exact implementation approach and configuration is determined based on the needs of the protocol, and TRI have a team of
Operational Consultants who can advise on the best approach.
Platform studies are a great use case for RBQM as long as your tools allow them to be set up effectively, as OPRA does. AI is already becoming a key component to RBQM and TRI are developing a suite of new tools to accelerate implementation, drive protocol design
and increase the efficacy and efficiency of the whole RBQM process. We would be happy to set up time with your organisation to walk you through our capabilities in this area.
We are in the process of developing AI and ML methods for proactive determination of patient risk, patient burden and likelihood of dropout. We have a number of working POCs in this area and would be happy to walk you through them.
