IRT/IWRS

Drug supply management and randomization for multi-site clinical trials, minimizing wastage and handling complex adaptive study designs.

Solution by SyMetric

Overview

IRT/IWRS is a Clinical Trial Management (CTM) solution developed by SyMetric that supports organized drug supply coordination across multiple investigation sites. It is designed for single-arm, large multi-arm, and multi-centred clinical studies, with a focus on reducing drug wastage and managing complex randomization procedures.

The platform addresses key operational areas of clinical trial management, including randomization, subject tracking, site administration, and investigational product (IP) supply management.

Randomization

Supports Dynamic Adaptive Randomization to avoid imbalance of covariates across subjects.
Produces balanced treatment assignments within covariate profiles regardless of sample sizes.
Uses accrued information from past treatment assignments and subject covariate values to determine the probability of future treatment assignments.

Subject Management

Provides tools for subject screening and enrolment, visit management, IP dispensing and receipt, unblinding, withdrawal, and study completion.
Tracks different subject statuses from screening through to study completion.
Helps sites meet study enrolment and completion targets within planned timelines.

Sites Management

Allows registration, configuration, and management of investigation sites within the platform.
Enables clinical research monitors to activate, deactivate, and reactivate sites based on study-specific requirements and site performance metrics.

Clinical Supplies Management

Provides IP supply management functionality allowing drug supply managers to control supplies sent to sites.
Supports adjustment of supply strategies based on remaining treatment arms and updated ratios.
Enables on-demand labeling and shipping strategies to reduce supply waste on adaptive trials.
Aims to reduce the overall costs of investigational product in clinical trials.

SyMetric's IRT/IWRS platform is accessible via the SyMetric Portal and is also available through the SAP Store, indicating integration within broader enterprise environments.