Study Protocol Risk Assessment

MyRBQM Functional Service Provision

Risk Assessment

Impact, probability, and detectability assessment

Risk Mitigations

Protocol-based mitigation actions

Protocol Amendments

Protocol optimization suggestions

Optimizing Study Protocols

Enhance the practicality and efficiency of your study protocols. Bridge the gap between protocol development and real-life execution risks by leveraging AI-augmented risk assessment support that aligns directly with risk-based quality management processes as per the most recent ICH GCP guidelines.

  • AI-Augmented Risk Assessment Aligned with ICH GCP Guidelines

Would you like to optimize in the area of:

  • Protocol Risk Evaluation

    • Assessing risk probability and detectability can be a challenging endeavor.
  • Clinical Trial Process Compliance

    • Gaps in risk assessment often lead to non-compliance.

Protocol Optimization Opportunities

Explore how we can support you:

  • RBQM Risk Scoring & Prioritization

    • Utilize decades of risk-management experience in assessing risk impact, probability, and detectability.
  • RBQM Process Transformation

    • Allow us to align your study protocol with risk-based processes and create tailored mitigation actions.

MyRBQM Your Functional Service Partner!

Get to Know the Struggles of Adhering to the Protocol

Navigating Optimization Together

Step 1

Protocol & CRF Assessment

Step 2

Review Protocol & CRF

Step 3

Draft Risk Assessment

Step 4

Stakeholder Discussion

Step 5

Final Report: Risk Assessment & Risk Score

Get the Advice of Our FSP Experts

RBQM transformation starts here.

Explore Our Other Functional Services

  • RBQM SOPs & Gap Analysis

We help your organization implement a system to manage quality throughout all stages of the trial process. Besides providing you with the appropriate templates, we help identify gaps in the existing standard operating procedures and recommend changes based on industry best practices.

  • Centralized Monitoring

Centralized Monitoring within a risk-based framework can alleviate many of the considerable barriers compared to traditional site-based studies. Our team of experienced Central Monitors helps you oversee the conduct of your trial and timely address risks while the study is ongoing.

  • Quality of Clinical Data Report

Unbiased, customizable Quality of Clinical Data Report, meticulously crafted to complement the clinical due diligence process. By furnishing a reliable, unbiased, and comprehensive clinical data assessment, buyers can confidently make informed decisions in pharmaceutical M&A.