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RBQM TECHNOLOGY OPRA

Quality Efficiency Compliance

OPRA Risk-based Quality Management software platform dashboards and data visualizations

Top 5 OPRA Benefits

  1. Quality - Increased data quality 

  2. Efficiency - Focus resources on the most important areas

  3. Compliance - Full end-to-end quality management

  4. Actionable - Spot outliers, risks, & trends to intervene early

  5. Configurable - Configure roles, user access, risk scoring models, dashboards, reports, & more 

OPRA the operational platform for risk analysis is the industry leading riak based quality management (rbqm) technology coveing risk assessment and management and central statistical monitoring
BSA Funnel Plot example from OPRA the RBQM technology for Central Monitoring in Clinical Studies

How OPRA delivers end-to-end quality management

How OPRA deliveres end to end RBQM
OPRA RAM

OPRA Risk Assessment & Management (RAM)

OPRA Risk Evaluation Model for creating bespoke clinical study risk models

OPRA RAM Features

  • Owned by the Risk Manager (from central RM / QM function) to ensure consistency across all risk assessments

  • Cross functional involvement in risk library development and risk selection per study

  • Involvement from critical vendors / CROs

  • Sometimes owned by Project Manager or Central Monitor (typically smaller organizations)

OPRA RAM Risk Category displaying the risk status
OPRA RAM clinical study risk categories defintion description and risk scores
ORA RAM Risk Score dashboard showing clinical study risks, rsk scores, risk ratings and risk tends
OPRA RAM Risk Dashboard identifying risks in a clinical study
OPRA RAM clinical study Risk Status graphic

Typical User Profile & Use Cases

  • Add / import Critical Variables

  • Select Risks (and Controls) from library / import / create

  • Add additional Controls

  • Associate Risks with Variables

  • Score risks

  • Define ownership and review schedule

  • Select KRIs and refine ISMP

  • Issue Functional Plans

  • Ongoing risk review and update

  • Interim and final reporting

OPRA CM

OPRA Central Monitoring (CM)

OPRA Central Monitoring Dashboard showing data visualizations including Adverse Events
OPRA Central Monitoring Dashboard with data visualizations
OPRA Central Monitoring Dashboard showing data visualizations
OPRA Central Monitoring data visualization showing Out of range Lab results
OPRA Central Monitoring data visualization showing Key Risk Indicator (KRI) Score Chart

  • KRI / KPI / QTL / Data table selection

  • Threshold and weightings configuration

  • Risk Overview Review

  • KRI / Site / Patient data review

  • Root cause analysis

  • Observations and Actions tracking

  • Activity review

  • Study and Site level monitoring comments

  • Central Monitoring Reporting

OPRA CM Features

OPRA Central Monitoring data visualization showing BSA score change funnel plot

Typical User Profile & Use Cases

  • Typically, Central Monitor from CM function.

  • Possibly Lead CRA or Project Manager in smaller organizations

  • Data Manager for statistics monitoring (sometimes separate from CM)

  • Emerging Medical Monitoring usage – expected to increase:

    • OPRA Roadmap

    • DCTs

How OPRA CM works

How OPRA Central Monitoring works including data drill down through primary visualizations and data tables

Clinical & Operational

Data Sources

Primary Visualizations

& Data Tables (KRIs/KPIs/QTLs)

Drill down into companion

visualizations and data tables for deeper review and analysis. Enables root causes analysis and investigation into specific quality risk areas.

OPRA CM Dashboards

CM Dashboard v4.PNG

  • Data is aggregated from any clinical and operational data sources to produce study specific dashboards for central review and decision making

  • The data you choose, and how you want that data to be modeled and visualized is totally flexible, based on the needs of the study and the approach of the Sponsor or CRO using the platform

  • Site level data visualizations give insights into quality and performance, allowing individual sites to be compared with country and study summary data

  • Subject level data can be viewed in data tables, allowing sorting, filtering and grouping of data within OPRA or export to Excel

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