Contributing Expert at Medrio: Ian Davison, RTSM Subject Matter Expert
If you work in clinical operations or clinical trial supply management, you’ve probably heard of Interactive Response Technology (IRT). But what exactly is IRT, and why does it matter for your trials?
This guide will help you answer the questions:
- What is IRT in clinical trials?
- What is RTSM?
- How do IRT and RTSM differ?
- What are the primary functions of an IRT?
- Who uses an IRT?
- What are the benefits of IRT?
- What role does RTSM play in early phase clinical trials?
- How does IRT optimize clinical supply management?
- What should you look for in an IRT or RTSM vendor?
What is IRT?
Interactive Response Technology (IRT) is a term often used interchangeably with RTSM. The acronym is based on a series of similar technologies.
IVR or IVRS (Interactive Voice Response System) provided similar, though limited, functionality via touch-tone telephony. IWR or IWRS (Interactive Web Response System) migrated this technology to the web. IXRS (Interactive Voice/Web Response System) was used to describe hybrid systems. IRT is simply the next in line.
What is RTSM in Clinical Trials?
Randomization and Trial Supply Management (RTSM) is a digital system used in clinical trials defined by its functionality.
This technology is used to manage the participant’s journey through a clinical trial, including randomization, investigational product (IP) allocation, and trial supply management. It automates key processes like assigning treatment arms, tracking inventory, and managing site shipments.
Want to know more? Check out our blog post, “What is RTSM in Clinical Trials?“
IRT vs RTSM
While often used interchangeably, IRT typically refers to the technology platform, while RTSM emphasizes the combined management of randomization and supply chain.
Modern vendors usually provide both under one system.
Primary Functions of an IRT
In all clinical trials, the entire product life cycle must be tracked and sponsors must destroy unused stock. But excess unused stock wastes costly investigational product (IP) and adds to the expense of running a study.
Clinical trial IRT software plays a central role in clinical trial supply management. The right solution ensures that studies run efficiently and remain compliant. It also prevents waste, which can reduce costs.
An IRT’s key functions include:
- Randomization management: Assigning patients to treatment arms using preset algorithms to reduce bias
- Blinding enforcement: Ensuring no unblinded clinical trial data reaches sponsors, CROs, investigators, or site staff
- Supply chain management: Tracking site inventory, triggering automatic resupply, and managing expiry and returns
- Visit and dose tracking: Logging each subject’s visit, dosing schedule, and drug assignment
- Incident handling: Dealing with problems such as temperature excursions, damaged or lost IP
- Reporting and reconciliation: Providing trial managers with up-to-date dashboards on trial status and supply chain health
Together, these functions create a reliable foundation for trial success. They connect every part of the supply chain management process, ensuring nothing is missed. With IRT in place, teams can focus on the science rather than system headaches.
Ready to start planning? Explore these key considerations for supply chain optimization.
Who Uses an IRT?
IRT systems support a wide range of stakeholders in a clinical trial. Each group relies on the system to meet specific needs and ensure success.
- Clinical Operations Teams: Monitor enrollment progress, ensure protocol compliance, and stay on top of trial milestones
- Supply Managers: Oversee drug shipments, manage site inventory, and anticipate resupply needs to avoid shortages
- Investigators/Site Staff: Use IRT to randomize patients, track visits, and document dosing accurately
- Data Managers: Align IRT data with EDC and other systems to maintain data consistency across the trial
- CROs: Coordinate outsourced trial activities and align sites, sponsors, and vendors
Without these stakeholders working together, a clinical trial can easily face delays or compliance risks. The IRT acts as a central hub, keeping all teams informed and connected.
Benefits of IRT
An IRT system does more than just randomize patients. It serves as the operational backbone of a trial. The right system ensures every action is tracked, all supplies are where they need to be, and every step follows protocol.
When used well, this system helps clinical and supply teams avoid delays, errors, and regulatory setbacks.
Key benefits of an IRT include:
- Randomization removes human bias by assigning participants to treatment arms using pre-set algorithms. This function ensures statistically valid results and keeps enrollment on track.
- Blinding maintenance maintains study integrity by preventing treatment allocation data from being accessed by site staff or investigators. This ability helps protect the trial from inadvertent bias or unblinding.
- Supply chain tracking monitors inventory levels at each site in real time. The system triggers automated resupply when thresholds are met, ensuring IP is always available without overstock.
- Inventory optimization allocates IP based on site performance, projected enrollment, and expiry dates. This approach minimizes waste and balances drug distribution across regions.
- Reporting delivers dashboards and important data to clinical teams, showing enrollment metrics, site activity, and supply trends. This feature helps stakeholders make informed decisions fast.
By consolidating these functions, IRT improves data quality, trial efficiency, and team coordination—especially in fast-moving early-phase studies.
The Role of RTSM in Enabling Early Phase Trial Success
Some research teams rely on manual methods of randomization, cohort assignment, and trial supply management in early phase studies. In fact, in some therapeutic areas, like oncology, early phase studies tend to be more complex than later phase ones.
Relying on manual processes for too long can expose organizations to unnecessary risks. Many organizations find that an IRT or RTSM is just as valuable early on as it is for Phase III and beyond.
Benefits of RTSM in any phase:
- Eliminate selection bias
- Protect proper blinding
- Reduce human error
- Meet regulatory compliance criteria
- Manage budget by reducing waste and overages
- Reduce drug launch timelines
- Free up managerial resources
RTSM can help manage the complexities and multiple changes that are common in early phase trials. A robust RTSM ensures that IP is allocated correctly, reducing the possibility for human error.
How an IRT Optimizes Clinical Supply Management
Clinical supply management is one of the most critical — and challenging — parts of running a successful trial.
An IRT system plays a central role in optimizing this process, offering supply teams the visibility and control they need. With the right IRT in place, sponsors and CROs can reduce waste, prevent shortages, and improve the overall efficiency of their supply chain.
The right IRT solution helps supply teams:
– Predict resupply needs
– Avoid overstock/shortages
– Schedule shipments efficiently
– Manage temperature-sensitive products
– Track full product movement
Want to know more? Find out how to optimize clinical trial supply management.
Choosing a Vendor
An experienced technology partner can help increase efficiency and reduce waste. Legacy systems often require manual input, whether paper-based or digital. But a unified, cloud-based RTSM with automations is faster and less prone to user error.
Look for a vendor with:
- Experience in all study phases
- Platform flexibility to meet individual study protocol needs
- Integration with your EDC or other systems
- A strong reputation for support and service
Comparing RTSM options? Learn how to select the most effective RTSM.
About Medrio RSTM
Clinical trials are increasingly complex, but optimizing your supply chain doesn’t have to be. Medrio RTSM software helps you start trials faster and manage risk easily. You can configure study parameters in hours and deploy in just 4-5 weeks.
With Medrio RTSM, there is no custom coding or rigid systems—just seamless randomization and supply management, fully integrated with Medrio CDMS/EDC.
Medrio RTSM features include:
- User-friendly interface
- Flexible setup for protocol changes
- Live reporting features
- 24/7 vendor support
- Strong regulatory compliance
Designed to meet customer needs, it adapts to complex protocols and mid-study changes without costly delays. With seamless Medrio CDMS/EDC integration and 24/7 expert support, you can keep your trials moving.
Want to explore Medrio RTSM? Schedule a demo.
Interactive Response Technology FAQ
Common questions about IRT in clinical trials.
What does IRT stand for?
IRT stands for Interactive Response Technology. This technology is used for randomization, blinding, and supply management in clinical trials.
What is IRT randomization?
IRT randomization involves assigning participants to treatment arms using preset algorithms to reduce bias.
What is the difference between IRT and RTSM?
IRT refers to the general technology platform, while RTSM emphasizes randomization and trial supply management as combined functions.
Why is IRT important for clinical trial supply management?
IRT ensures efficient drug distribution, prevents shortages or overages, and provides real-time inventory visibility in clinical trial supply chain management.
Who typically manages the IRT system?
Clinical operations, supply managers, and CROs work together to configure, monitor, and maintain the IRT system throughout the trial.
