Risk based clinical
trials need OPRA 5
OPRA 5 has been created to address the industry need for a complete RBQM technology solution. One that enables operations teams to manage data quality from the start, right the way through to the end of a clinical trial.
OPRA 5, along with our training and support services, is designed to optimize clinical trial quality by improving data reliability. This increases both patient safety and operational efficiency.
Use our comprehensive library of data exports and standard reports to report on risks and risk management activity.
Export pdf reports for inclusion in TMF.
A comprehensive reporting suite for: ongoing risk management; central monitoring; quality management activity; CRO and Sponsor collaboration; and inclusion in the Trial Master File.
Develop your own risk evaluation model or use our standard models.
Evaluate each risk and re-evaluate during risk reviews to prioritize what's important, and see trends over time.
Identify and capture data and processes critical to quality.
Record supporting metadata, such as data source and justification for inclusion.
Assign risk controls, KPIs, KRIs and QTLs to your risks from your controls library, or by defining new controls.
Assign control owners, review frequencies and links to central monitoring.
Detail the risks to each critical variable, either by importing from your risk library or adding new risks.
Assign functional ownership, review frequency and other key characteristics of risk.
Communicate risk and risk control ownership.
Document risk management activities, decisions and timelines.
Set risk review alerts and review risk dashboard and risk log.
Update and add new risks and controls as needed.
Use the intuitive dynamic UI to drill down to risk details and review risk trends over time.
Is there any more important management task than ensuring your staff are properly trained?
Our GCP and Risk Assessment & Controls e-learning modules are the fastest and most cost effective way to get your staff trained. Created by our operational expert team, they are comprehensive and intuitive, making learning quick, easy and entertaining.
Sponsors and CROs can try the modules for free. Customers get the additional bonus of 75% of list price if they buy within 4 weeks of completing the free trial.
June 22, 2021 - Worldwide Clinical Trials announce partnership with TRI:
“Our methodical, holistic, approach to RBQM is part of Worldwide’s vision to be the best midsize CRO,” said Peter Benton, president and co-CEO of Worldwide. “Worldwide’s RBQM team is one of the most experienced CRO teams in the industry. This, coupled with TRIs 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.”