Late Phase Trials

RTSM – Randomisation and Trial Supply Management

RTSM is an integrated Randomisation and Trial Supply Management solution designed to control patient allocation and investigational product supply in late-phase clinical trials. By combining protocol-driven randomisation with intelligent trial supply management, RTSM ensures unbiased treatment assignment, uninterrupted drug availability, and end-to-end operational visibility—while maintaining strict regulatory compliance across global studies.

Key Benefits

1

Bias Prevention

Eliminates selection bias through controlled, protocol-driven randomisation processes.

2

Supply Continuity

Ensures uninterrupted availability of investigational product at all trial sites.

3

Operational Efficiency

Reduces manual coordination between enrolment and supply teams through integrated workflows.

4

Allocation Accuracy

Improves accuracy in treatment assignment and inventory utilisation across studies.

5

Waste Reduction

Optimises supply forecasting to reduce overstocking, expiry, and drug wastage..

6

Inspection Readiness

Maintains audit-ready compliance across randomisation and trial supply operations.

Services Section

Key Functionalities

Protocol Randomisation
Executes protocol-defined patient randomisation and treatment assignment to eliminate selection bias.
Enrolment Management
Manages real-time patient enrolment, stratification, and cohort progression across sites.
Supply Planning
Integrates trial supply planning with enrolment data to align drug availability with patient demand.
Drug Allocation
Automatically allocates investigational product based on randomisation outcomes and protocol rules.
Inventory Tracking
Tracks inventory at site and depot level with automated re-supply triggers to prevent shortages.
Lot & Expiry Controlg
Manages lot, batch, and expiry tracking across the supply chain to ensure compliant drug usage.
Automated Alerts
Tracks inventory at site and depot level with automated re-supply triggers to prevent shortages.
Audit Trails
Maintains complete, time-stamped audit records for all randomisation and supply activities.
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faster patient randomisation and enrolment workflows

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reduction in supply-related delays and stock-out incidents

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improvement in trial supply forecasting accuracy

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traceable and auditable randomisation and supply records

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