mindsON RBQM
eSeries

Expert-led RBQM learning modules designed to help clinical teams apply risk-based oversight consistently in real study environments.


Built from the industry-recognized mindsON RBQM workshop series and re-developed into structured on-demand learning experiences.

Ideal for quick and focused capability development

mindsON RBQM eSeries consists of professionally developed on-demand learning modules focused on practical RBQM implementation and oversight activities in clinical trials.


Each module addresses one operational topic, combining practical guidance, real study examples, implementation considerations, and lessons learned from sponsor and CRO environments.


Aligned with ICH E6(R3) and QbD principles, the eSeries supports teams responsible for:

  • risk-based oversight
  • centralized monitoring
  • quality management
  • risk assessment activities
  • operational RBQM rollout


The modular format allows individuals and teams to strengthen capability in targeted areas without committing to full certification pathways.

What’s included

Two flexible learning options:

mindsON RBQM Essential Bundle

Modules 1–7

A structured learning pathway. Ideal for organizations building cross-functional RBQM capability across teams and studies. Bundle pricing available.

Individual Modules

Select targeted implementation topics based on operational needs, team responsibilities, or oversight priorities. Each workshop includes:

Current modules include:

 

Module 1 – Critical Data & Critical Processes

Module 2 – Risk Identification

Module 3 – Risk Evaluation

Module 4 – Risk Control (incl. KRIs & QTLs)

Module 5 – Risk Communication & Review

Module 6 – Root Cause Analysis

Module 7 – Linking Risks & Issues

Module 8 – Key Risk Indicators (KRIs)

Module 9 – Quality Tolerance Limits (QTLs)

Module 10 – Clinical Trial Oversight

Module 11 – Critical Thinking

Module 12 – Outsourcing RBQM


(New modules are regularly added – stay tuned for the latest!)

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Active learners building RBQM capability

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Organizations supported in RBQM adoption

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Professionals trained in applied RBQM

Used by teams across leading sponsor and CRO organizations

Supporting RBQM capability and implementation across global clinical organizations.

Need support beyond e-learning?

Some organizations require additional operational support when implementing RBQM, QbD, or AI-supported oversight activities. Our SMEs support RBQM and QbD implementation, SOP development, oversight design, risk assessments, and team rollout activities.
SME SUPPORT

AI Use in Clinical Trials Is Increasing.
So Are Regulatory Expectations.

Regulators expect controlled, documented, and reviewable AI use. Prepare your teams to apply AI within GCP and computerized system requirements.