Late Phase Trials

RAMP – Risk Assessment and Management Program

RAMP is a structured risk assessment and management solution designed to ensure that only protocol-eligible patients are enrolled in late-phase clinical trials. By standardising eligibility assessments and enabling controlled medical review prior to enrolment, RAMP helps prevent protocol deviations, enhance patient safety, and protect data integrity across global studies.

Key Benefits

1

Eligibility Control

Prevents enrolment of ineligible patients through rule-based eligibility checks aligned with the study protocol.

2

Patient Safety

Protects patient wellbeing by enforcing strict eligibility criteria and controlled screening decisions.

3

Deviation Reduction

Reduces eligibility-related protocol deviations and minimises downstream rework.

4

Decision Consistency

Ensures uniform eligibility decisions across sites and regions, eliminating variability from manual interpretation.

5

Data Integrity

Strengthens data quality by ensuring eligibility information is accurate, complete, and traceable.

6

Inspection Readiness

Maintains audit-ready documentation to support transparent and confident regulatory inspections.

Key Functionalities

Eligibility Workflow
Implements protocol-driven medical eligibility assessment workflows to ensure consistent and compliant patient screening.
Medical Review
Enables controlled medical review and approval before patient enrolment to reduce eligibility-related risks.
Criteria Standardisation
Standardises eligibility criteria across all trial sites to ensure uniform interpretation and execution.
Status Visibility
Provides real-time visibility into eligibility review status to support timely enrolment decisions.
Audit Trails
Maintains complete, time-stamped audit records of all eligibility assessments and approvals.
Deviation Prevention
Integrates automated controls to prevent ineligible enrolment and reduce protocol deviations.
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reduction in eligibility-related protocol deviations

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faster eligibility review and medical approval cycles

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accuracy in patient enrolment through controlled eligibility verification

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auditability of eligibility decisions and approvals for regulatory confidence

Let's understand how you manage your Late Phase Studies?