Risk Assessment and Mitigation

Identify, Interpret, and Document Trial Risks

1
Questionnaire

Implement Risk Assessment specific to your trial and therapeutic area.

2
Assess Risk

Engage all stakeholders to collaboratively assess each trial for risk, with version control and audit trail.

3
Document Risk Strategy

Document your complete Risk Control Strategy including KRIs and thresholds.

4

Document your complete end-to-end risk assessment in the TMF.

Hover over the toggles to discover the features.
FIND STUDY RISKS FAST

Begin your ICH E6 (R2) compliance by performing a comprehensive study risk assessment that informs you as to the vulnerable areas of your trial, while providing the ability to define risk controls and monitoring capabilities so that you’re able to spot risk evolving during study execution. Maintain a dynamic, versioned risk assessment with full audit trial automatically captured from all stakeholder input.

Connect with an Expert
1
Questionnaire

Implement Risk Assessment specific to your trial and therapeutic area.

2
Assess Risk

Engage all stakeholders to collaboratively assess each trial for risk, with version control and audit trail.

3
Document Risk Strategy

Document your complete Risk Control Strategy including KRIs and thresholds.

4

Document your complete end-to-end risk assessment in the TMF.

Hover over the toggles to discover the features.
  • ICH E6 (R2) Compliance for performing a study risk assessment
  • Define you risk control strategy, KRIs and thresholds
  • Identification of critical data and processes to inform a risk assessment
  • Define risk evaluation questionnaires specific to your trials/needs
  • Expedite risk assessment by reusing from templates and libraries
  • Support both internal and external stakeholder collaboration through the web-interface
  • Create new risk assessment versions when required
  • Capture all modifications with the audit trial
  • Report the entire risk assessment process for filing in the TMF
  • Clinical Trial Risk Assessment supporting the ICH E6 (R2) Risk-based Quality Management approach

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Whether you’re looking to get started or need support, we’re here to help!

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Created in conjunction with our peers at TUFTS Center for the Study of Drug Development, this paper provides insights on how companies are responding to ICH E6 (R2) and information on the key themes on adoption.

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This recorded webinar covers all of the frequently asked Questions about ICH E6 (R2), Risk-Based Study Execution (RBx) and what’s required from a people, process & technology standpoint.

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