Managing patient groups, ensuring accurate randomization, and overseeing investigational products across many global sites has also become more challenging.
To meet these needs, Randomization and Trial Supply Management (RTSM) systems also called Interactive Response Technology (IRT) now play an essential role in clinical trials.
The World BI Global Clinical Trial Supply Forum gives you the opportunity to learn how to improve cost efficiency, deliver supplies more effectively, and run smoother operations by using IRT technology.
Interactive Response Technology (IRT)
This technology has come a long way from the early phone-based systems (IVRS) and simple web tools (IWRS) to the advanced RTSM platforms used today. IRT now acts as a core operational system for clinical trials. It helps make sure patients are randomized correctly, study drugs are supplied efficiently, and all data stays accurate and reliable.
The Rise of RTSM Technology
Clinical trials were managed manually using paper randomization lists, sealed envelopes for emergency unblinding, and handwritten drug supply logs.
Phone-based Interactive Voice Response Systems (IVRS) became the first big step towards automating trial processes.
Web-based Interactive Web Response Systems (IWRS) offered easier access, faster updates, and improved accuracy.
Modern RTSM systems are much more powerful and are usually offered as SaaS (software-as-a-service). They now include:
- Integration with other clinical trial technologies
- Support for complex or adaptive trial designs
- Direct-to-patient drug delivery options
- Cold-chain and temperature monitoring capabilities
- Advanced analytics to improve supply planning and reduce waste
Overall Impact:
Today's RTSM tools help accelerate trials, improve efficiency, and handle the growing complexity of modern research.
Key Features of an Effective RTSM System
1. Patient Cohort & Randomization Management
- Supports both simple and advanced randomization methods
- Uses smart algorithms to ensure fair and accurate patient assignment
- Includes features like patient stratification, emergency unblinding, and automated cohort handling
- Helps maintain accuracy and flexibility throughout the trial
2. Drug Supply Management
- Tracks drug inventory in real time
- Automatically triggers resupply so sites never run out or overstock
- Manages expiry dates, temperature issues, and drug returns
- Helps reduce waste and maintain full compliance
3. Patient Management
- Simplifies patient screening and enrollment
- Automates visit schedules and manages drug dispensing
- Tracks patient status in real time
- Helps sites follow the protocol and support patient-focused operations
4. Integration with Other Systems
- Easily connects with major eClinical tools like EDC, CTMS, eCOA, and eConsent
- Integrates with supply chain systems and lab platforms
- Creates smooth data flow across the entire study process
5. Reporting & Analytics
- Offers real-time reports on enrollment, site performance, and supply levels
- Includes tools for compliance documentation and regulatory reporting
- Helps teams make informed decisions quickly
Why RTSM Solutions is very Important in Clinical Trials?
Direct-to-Patient Capabilities
- Works with supply partners to deliver study drugs directly to patients
- Safely manages patient addresses and supports decentralized trials
- Reduces patient burden and keeps regulatory standards intact
Temperature Excursion Management
- Tracks temperature deviations automatically
- Enables quick decisions on whether a product is still usable
- Helps meet GDP requirements while reducing unnecessary drug waste
Rapid Implementation
- Can be set up in just a few weeks
- Faster than the usual industry timeline (8+ weeks)
- Can handle mid-study changes without delays
Just-in-Time Manufacturing
- Uses real-time data and forecasting to reduce drug waste
- Cuts storage costs
- Ensures the right amount of drug is available at sites
Drug Pooling
- Allows study drug inventory to be shared across multiple studies or programs
- Reduces over-production and lowers the risk of stock shortages
Global Project Delivery
- Supported by global teams specializing in biostats, clinical science, logistics, and regulatory areas
- Helps sponsors run multi-country trials smoothly
- Reduces operational risks and speeds up study setup
Case Study Example: Modern RTSM in Action
This example shows how modern RTSM systems can handle complex trials while making participation easier for patients.
A multinational pharma company needed to switch mid-study to a direct-to-patient model in a pediatric immunology trial across 8 countries and 20 sites.
Signant's advanced RTSM system and experienced project team enabled:
- Flexible visit schedules and transitions
- Integration with home nurses
- Patient preference options for convenience
- Continuous investigator oversight and drug accountability
The trial maintained integrity and compliance while improving patient experience and operational efficiency.
Implementation in Clinical Trials
While RTSM systems are widely used, they are often considered late in the planning of eClinical technologies. This can lead to rushed setups to meet the "first patient in" timeline and missed opportunities to design a system that works across multiple trials. To avoid these issues, follow these recommendations:
- Choose the Right Solution: Pick an RTSM system with the key components and features discussed earlier.
- Engage Stakeholders Early: Include all teams in trial planning to cover system integration, packaging, and drug dispensing needs.
- Define Requirements Clearly: Outline workflows and system requirements upfront.
- Plan Comprehensive Testing: Ensure the system is thoroughly tested before go-live.
- Train Users Well: Develop a clear training program for all users.
- Manage Changes Carefully: Create a plan to handle updates or protocol amendments.
Future Trends
AI & Machine Learning
- Helps with smarter supply forecasting
- Automates checks for protocol compliance
- Optimizes patient assignment and site selection
Enhanced Automation
- Streamlines resupply decisions
- Reduces manual work for trial teams
Support for Decentralized Trials
- Improves direct-to-patient drug delivery
- Enables remote monitoring of patients
- Uses mobile-first interfaces for easier access by sites and patients
Visit World BI and book for Global Clinical Trial Supply Forum US.