OPRA Subject Monitoring

Oversight You Can Trust in Low‑Volume, Early‑Phase Studies

Subject‑Level Clarity That Fuels Confident Decisions

Confidence in every decision.

Clarity on every subject

Get an immediate, complete picture of each subject’s journey without piecing together disconnected data.

Faster Risk Recognition

Spot meaningful shifts sooner with clear, time‑aligned patterns and anomalies.

Reliable, defensible oversight

Remove variability and strengthen quality with a standardised, audit‑ready review process.

Aligned decision‑making

Give medical monitors and reviewers the same contextual view so decisions are consistent and well‑informed.

How OPRA Subject Monitoring Supports You

Time‑Aligned Subject View

All visits, AEs, labs and assessments displayed on a single, chronological timeline for instant clarity.

Built‑In Audit Trail

Every review action is captured automatically in a validated, inspection‑ready environment.

Role‑Based Access Control

Ensure the right people see the right data with controlled, compliant user permissions.

Easily Compare Subjects

Quickly view similar subjects side‑by‑side to sense‑check patterns without exporting data.

Why OPRA?

Real-time insights

Availability of up-to-date risk scores

Trend analysis

View evolution of risks over time

Collaboration

Centralized portal to collaborate with stakeholders

Alerts

Customizable alerts

Data visualizations

Customizable data visualizations

Version control

Eradicates duplication

Assign actions

Assign actions to stakeholders

Audit ready

Full discoverability of mitigations after closeout

Why Choose TRI?

Trusted

Dependable software. Genuine trust. TRI delivers, on time, at scale, with clarity.

Responsive

In a rigid industry, we’re the human touch: pragmatic, responsive, and known by name.

Innovative

We lead, not follow. TRI is fast-moving and data-informed, staying ahead of Sponsor and CRO needs.

RBQM Success Stories

"Worldwide’s RBQM team is one of the most experienced CRO teams in the industry. This, coupled with TRI’s best-in-class technology, ensures we can proactively identify and manage risks, meaning improved quality and patient safety, and, in turn, provide a better experience for sponsors and patients."

"What truly set TRI apart from other vendors was their unparalleled commitment to a quality deliverable helping us effectively apply a novel approach to our operations. They achieved a deep understanding of our objectives by partnering with us on a rigorous change management process which culminated in a shared vision for the integration of their risk assessment and central monitoring solution."

"The Worldwide Clinical Trials team is pleased with our continued partnership with TRI and we are excited about the milestone of having 150 clinical trials in TRI's Risk-Based Quality Management platform. This is a key benefit for our customers as it improves data quality, trial efficiency, and patient safety."

"It has been such a wonderful ride with our TRI partners over the last few years developing our RBQM strategy with our Sponsors and Worldwide Clinical Trials Teams! We love working with everyone at TRI and look forward to bigger and better things to come!"