Where are you on your
Our e-learning content is the fast, easy, and effective way to get your team up to speed on RBQM and R2.
E6 (R2) Fundamentals
Protocol Risk Assessment
Full ICH E6 GCP including R2 revisions
Half-day workshops where you get lots of practical hands-on experience in addition to the opportunity to network with industry peers. and get free consultancy from our RBQM experts.
If you want the 'personal touch' we can create bespoke training based on your protocols, processes and procedures. Training can be delivered on-site or remotely to suit your team.
Quickly and easily plug those R2 gaps with our proven SOP, Plan, and Reporting templates, including:
Risk Assessment and Management SOP
Central Monitoring SOP
Quality Risk Management Plan Template
If you don't have the time or resources in-house to adapt, check and implement the SOP Pack, save time and speed up the process and let us do that for you
Delivering change is difficult in every organisation. It requires vision, insight, commitment, and clear and effective communication. It needs a special set of skills. Ask for help from experienced people who have been there and successfully done that.
OPRA is our industry-leading technology platform for Risk Assessment, Risk Management, and Centralized monitoring
Risk Assessment & Management
OPRA RAM is a fully validated tool based on the E6 (R2) Quality Management end-to-end process.
It is the most advanced Risk Management tool available on the market today. Your team can quickly and easily identify, monitor, manage, and report on the critical data and processes, giving you a full audit trail on the reasons for the risk-related decisions made on your trial.
No more messing around with Excel, version control or lost documents, OPRA RAM will tranform the way you manage your trial risks.
OPRA CM is a fully validated tool that uses statistical algorithms and data visualization to enable you to quickly and easily identify emerging risks and trends.
OPRA CM improves efficiency and effectiveness by enabling you to intervene early to stop problems escalating, and focus your valuable time on resources on the most important sites and issues.
Choose from our library of proven Key Risk Indicators, or we can create bespoke indicators specific to your study.
Study Set-up and Support
Our expert team can provide consultancy support, advice and guidance, tailored specifically for your study, including:
Protocol Risk Assessment, Integrated Strategic Monitoring Plan, Central Monitoring Approach,
Key Risk Indicators (KRIs), Key Performance Indicators (KPIs), Quality Tolerance Limits (QTLs),
Statistical Models and ongoing study support.
Whatever your RBQM study support requirements, we're sure we can help.