Do I need an IRT/RTSM for my clinical trial?

While IRT/RTSM systems are not always mandatory, they offer a range of benefits that can significantly enhance the quality and efficiency of clinical trials which makes them a must-have addition to virtually any clinical trial.

What is Interactive Response Technology (IRT)?

Interactive Response Technology is a software system used in clinical trials to manage patient enrollment, randomization, and drug supply throughout the study. It supports efficient data collection and ensures that participants are assigned to the right treatments and receive the correct medications.

For more details on IRT, check out:

What is IRT and How Does it Impact Clinical Trials?

What is Randomisation and Trial Supply Management (RTSM)?

Randomization refers to the process of assigning patients to different treatments (groups, arms, etc.) in a clinical trial, while Trial Supply Management refers to the handling of investigational products used in the trial.

Can an Interactive Response Technology/Randomisation system help my clinical study?

IRT/RTSM software applications are designed to automate and streamline various aspects of clinical trial management, including patient randomization, drug and investigational product dispensing and tracking, data collection and management, and regulatory compliance.

The decision to implement these systems depends on several factors, including the complexity of the clinical trial design, trial size, and geographical distribution of the study population.

In general, systems such as these are crucial for clinical trials that are:

• Complex: Studies with multiple treatment arms, adaptive designs, or complex randomization algorithms.
• Large in scale: Studies with a large number of participants or sites.
• Geographically distributed: Studies with sites located in different countries or regions.

However, even small, simple clinical trials today can benefit from these systems help to reduce the risk of human error, guarantee data quality, and streamline study management – ultimately saving time and resources.

What are the benefits of an IRT/RTSM system?

Protects patient safety: Ensure patients are assigned to the correct treatment arm and that they receive the correct corresponding investigational product.  The system also ensures that the right study drug is available on site for patients at the time of their visit, preventing any interruption of treatment. 

Ensures data integrity: Provide centralized real-time data collection and management to reduce the risk of data transcription errors and ensure that data is accurate and complete. This saves time and resources for data analysis and reporting within the clinical trial.

Increased efficiency: Streamline study management by automating what would be otherwise manual tasks, such as patient randomization, drug dispensing, and data collection. This can free up study staff to focus on more strategic tasks, such as patient recruitment and data analysis.

Improved regulatory compliance: Provide various tools to demonstrate regulatory compliance with the execution of the clinical trial. This can ensure that sponsors are better prepared for trial audits and inspections.

Final Thoughts

If you are considering using an IRT/RTSM system for your clinical trial, it is important to carefully evaluate your needs and select a system provider that is right for your study. Sever factors to consider include trial complexity, size, geographical distribution, budget, and provider service capabilities.

Once you have selected a system, it is important to work closely with the vendor to implement the system and train your staff. With proper planning and implementation, this can be a valuable asset and a true partner to your clinical trial’s success.