Quality Tolerance Limits
1
Assess Performance
Single QTL dashboard to present trial performance against all QTLs.
2
Document Justifications
Document all justifications for choosing QTLs and setting tolerance limits.
3
Document QTL Breaches
Record and document mitigation information against QTL breaches.
Hover over the toggles to discover the features.
MONITOR KEY METRICS
CluePoints’ Quality Tolerance Limits module offers Sponsors and CROs a convenient way to rapidly identify systematic issues, document the quality management approach and any deviations from the pre-defined Quality Tolerance Limits, all of which takes the study a step closer to being ICH E6 (R2) compliant.
1
Assess Performance
Single QTL dashboard to present trial performance against all QTLs.
2
Document Justifications
Document all justifications for choosing QTLs and setting tolerance limits.
3
Document QTL Breaches
Record and document mitigation information against QTL breaches.
Hover over the toggles to discover the features.
- Achieve compliance: Implementing Quality Tolerance Limits (QTLs) is recommended by both the FDA and ICH.
- Visually monitor key study metrics.
- Obtain complete documentation of Quality Tolerance limits with justification, evidence and thought processes in one place.
- Obtain complete documentation of Quality Tolerance Limit breaches with necessary evidence for the clinical study report.
- Automatically uncover significant patient safety issues or other scenarios that could put the validity of the trial into question.
- Early detection of such issues with downstream corrective actions.
Some examples of how our our customers are using Quality Tolerance Limits for their trials.
- Early End of Treatment Rate:
Rate of patients who have had an early discontinuation of study drug treatment. - Lost-to-Follow-up Rate:
The rate of enrolled patients that are lost to follow-up. - Early Termination Rate:
The rate of patients that have terminated the study prior to the primary endpoint milestone.
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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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