End-to-end RBQM. risk assessment, risk management and central monitoring in one easy-to-use technology platform. Drive quality, efficiency, safety and GCP compliance with the all-new OPRA 5.
Seven steps to risk management
success with OPRA 5
1 - Define your operating environment
Define user roles, access levels, libraries, review cycles and pick lists. Determine which customers, partners and vendors will collaborate in your risk management and assign access and security levels.
2 - Define your risk scoring model
Create a bespoke risk evaluation model specifically for your organization. Define values for Likelihood, Impact and Detectability based on your organization's risk culture and build tool tips into your scores to help training and consistency.
3 - Create your risk log
Create new risks, or import risks from your libraries. Associate risks with critical variables. Detail each risk with scores, review cycles, functional ownership and controls. Sort and filter your risk log for easy ongoing management.
4 - Set up your risk dashboard
Each user can be assigned to one or more studies and manage all aspects of risk through the risk dashboard. Use the dashboard to focus on what’s important to you and use the dynamic linking to click through to detailed risk views.
5 - Risk management & evaluation
As your study progresses, risks will change and actions will be taken. Re-score risks as needed and see historic trends as risk levels change. Record decisions, manage and monitor changes in our fully auditable system.
6 - Portfolio overview
Set up your portfolio overview to identify your high-risk studies and manage compliance. With visibility across your portfolio you will be able to assess the status of each risk assessment and identify where risk reviews are overdue and where SOPs are not being followed.
7 - One-click reporting
OPRA 5 has a comprehensive reporting suite for ongoing risk management, CRO and Sponsor collaboration, and inclusion in the Trial Master File. All reports are timestamped and stored for a full history of risk assessment and risk management over time.
Eight steps to central monitoring
success with OPRA 5
1 - Set up your organization & studies
Create roles, users, authorizations and permissions based on individual studies or whole organizations. You can also authorize specific access for your external stakeholders.
2 - Set up your study dashboard
Choose the data you want to manage (based on your risk assessment) and how you want to manage it. Choose the data sets, visualisation types and statistical models for KRIs, KPIs and QTLs, and screen layouts to create your own dashboards.
3 - Set up your study summary
Create a study summary for ongoing study reviews and high-risk site identification. Define additional information for risk level comparisons, such as site demographics.
4 - Drill down into the data
Root cause analysis paths ensure drill-down data is available at the click of a button, showing you where your risks are occurring and why. Use drill-down visualizations and data review tables to dive into site and patient level data. Data querying, sorting and filtering tools give you the view of data most helpful to you.
5 - Set up your site dashboard
Create site dashboards to review individual site and site subject data. How you review site and patient level data may vary from higher level risk indicators and so different statistical models and visualization types can be utilized.
6 - Site overviews
Site overview screens enable you to track and analyze trends at the site level. You don’t just want to know what’s happening today, but what’s the direction of travel and where you should be focusing your attention.
7 - Closed loop activity management
Create central review observations and actions. Assign actions to study team members, and manage those actions through to completion. Closed loop activity management gives you quality management activity tracking and a complete audit trail of all activities.
8 - Central Monitoring reporting
OPRA 5 comes with a comprehensive suite of standard central monitoring reports to report on all quality management activity and indicators at a site level and across a whole study.