Interactive Response Technology (IRT)

Interactive Response Technology (IRT), also known as RTMS or IxRS, solutions are sophisticated software platforms designed to streamline and automate various aspects of clinical trial management, particularly in patient randomization, drug assignment, and supply chain management.

These solutions play a crucial role in enhancing the efficiency, accuracy, and compliance of clinical trial operations by automating key processes and offering real-time oversight and control. However, a poorly designed system can act as a disruptive element in a clinical study, leading to increased time and costs for issue management and mitigation.

I can assess whether an IRT solution might benefit your study. If it proves advantageous, I can assist in selecting the right system, developing the User Requirements Specification, providing governance for the database build, and conducting User Acceptance Testing (UAT) before the Go-Live phase. Leveraging knowledgeable expertise to create and manage your IRT solution will contribute to the seamless execution of the study and the generation of high-quality data.

Key Functions of IRT Systems:

Patient Randomization: IRT systems facilitate the random assignment of patients to different treatment groups or arms in clinical trials. This process ensures the integrity and validity of trial results by minimizing bias and maintaining comparability between patient groups. Additionally, it helps keep sponsor and site team members blinded if applicable.

Drug Assignment: IRT systems manage the allocation and dispensation of investigational drugs to patients based on their assigned treatment groups. This ensures that patients receive the correct medication according to the trial protocol, maintaining blinding when necessary.

Inventory Management: IRT platforms track and manage the inventory of investigational drugs and other clinical supplies throughout the trial. This includes overseeing stock levels, monitoring expiration dates, and facilitating the shipment and distribution of supplies to trial sites. The use of powerful algorithms in IRT solutions minimizes the possibility of human errors.

Patient Management: Some IRT systems offer features for managing patient data, such as tracking patient visits, collecting patient-reported outcomes, recording informed consent or inclusion/exclusion eligibility, and managing study-specific assessments or procedures.

Real-Time Monitoring: IRT solutions provide centralized real-time monitoring and reporting capabilities, enabling study sponsors and site staff to track key trial metrics, monitor patient enrollment, and identify potential issues or deviations from the protocol.

Compliance and Regulatory Support: IRT systems help ensure compliance with regulatory requirements by providing audit trails, maintaining data integrity, and facilitating documentation of study activities. This support aids in regulatory submissions and inspections.

Core Services

  • Forecasting & Planning

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  • Manufacturing & Labelling Clinical Supplies

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  • Vendor Oversight

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  • Distribution & Logistics

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  • Inspection Readiness & TMF

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