Randomization and Trial Supply Management (RTSM) are critical components of clinical trials, ensuring that the assignment of treatments or interventions is unbiased and that the right supplies are available to participants. Here are the key features and capabilities of a Randomization and Trial Supply Management solution, such as that integrated into platforms like XcelTrials:
Support various randomization methods, including simple randomization, block randomization, and stratified randomization, to prevent selection bias.
Implement dynamic allocation of treatment arms based on ongoing study data, optimizing the balance of treatment assignments.
Register patients and assign treatment groups in real time, ensuring that each participant is randomized appropriately.
Assign unique treatment codes to maintain blinding and reduce the risk of unmasking the study.
Adapt the randomization ratio based on interim analysis results or specific criteria, optimizing study efficiency.
Automatically adjust drug and supply inventory based on randomization assignments to ensure that adequate supplies are available.
Monitor and manage the inventory of investigational products, supplies, and medical devices to prevent stockouts or overages.
Allocate supplies to study sites based on randomization assignments and patient needs, ensuring that the right materials are available where and when they are needed.
Manage the shipping and receiving of trial supplies, including temperature-sensitive materials, and track the status of shipments.
Facilitate the dispensation of drugs, therapies, or interventions to patients in accordance with randomization assignments and study protocols.
Monitor expiration dates of supplies and trigger alerts for expired or soon-to-expire materials.
Manage batches of investigational products and maintain traceability for regulatory compliance.
Seamlessly integrate RTSM with Electronic Data Capture (EDC) systems to ensure that treatment assignments and patient data are in sync.
Provide study personnel and site staff with real-time dashboards and reports to track supply status and allocation.
Capture and track adverse events related to investigational products, facilitating safety monitoring.
Ensure that randomization and trial supply management adhere to regulatory standards, including Good Clinical Practice (GCP) guidelines.
Customize randomization and supply management workflows to align with the specific requirements and objectives of each clinical trial.
A robust RTSM solution streamlines the randomization process, ensures proper allocation of supplies, and maintains regulatory compliance, ultimately enhancing the integrity of clinical trial data and the safety of participants.
XcelTrials is a single, compliant platform for collection and management of all clinical evidence, safety, and performance data.