Making RBQM simple
for all clinical trials.
What are you looking for today?
End-to-end RBQM in a single platform
that delivers efficiency, quality and compliance.
OPRA is the industry-leading RBQM technology.
Risk Assessment
& Management
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Protocol risk assessment
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Configure KRIs, KPIs, QTLs and visualizations
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Import data sources
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Create integrated monitoring plan
Central
Monitoring
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Central monitoring of studies, sites and subjects
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Data drill-down
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Review, monitor and mange trends and risks
Reporting
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Standard
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Bespoke
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Export
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Archiving
Designed by experts in delivering complex, global clinical trials.
Easy to use, validated, secure and compliant.
Don't just take our word for it... here's what other say about us
“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.”
Peter Benton, President and co-CEO
Drivers of RBQM - Regulation
E6(R2) - Quality Management
Identify
Critical
Factors
Identify
Risks
Evaluate
Risks
Control
Risks
Risk
Comms
Review
Risks
Reporting
Risks
E8(R1) - Quality By Design
General
Principles
Designing Quality
Drug Dev Planning
Design Elements & Data Sources
Conduct, Safety Monitoring & Reporting
Identifying Critical to Quality Factors
Drivers of RBQM - Data Generation & Quality
Medical Professional
generated
Source Data at site
Health Care
Professional
generated
Source Data at home
Patient
generated
Source Data at home
Technology generated
(DCTs)
Source data in the cloud
Drivers of RBQM - Data Source & Standards
Select core KRIs, KPIs, QTLs and data tables
Develop
core data specifications
Identify core data sources
Define study specific requirements
Drivers of RBQM - Challenges
Reliance on SDV
Non-Standard data
Data Volumes and DCT Risk Management
Early Phase Studies
Change Management
2023 thoughts on RBQM related topics
Helping you implement RBQM
We know from experience that implementing RBQM is hard, so we've developed a range of services to help support you in making your RBQM initiative successful.