Stratification, minimisation, adaptive algorithms, and unblinding procedures need to be configurable without workarounds.
IRT/RTSM guide
Best IRT/RTSM vendor for clinical trials: shortlist for randomisation, supply, and system reliability.
The best IRT/RTSM vendor is the one that delivers reliable randomisation and drug supply management with the flexibility to handle protocol complexity and the speed to keep up with study timelines.
Real-time inventory, automated re-supply triggers, and depot management reduce drug waste and site stock-outs.
IRT downtime directly impacts randomisation, dosing, and supply. Sponsors should demand proven uptime SLAs with measured track records.
Change control, UAT, and go-live processes should be fast enough to adapt to protocol amendments without delaying milestones.
What to test
Ask whether the IRT/RTSM vendor can handle the specific randomisation and supply complexity of the programme without custom build overhead.
- Randomisation algorithm flexibility for stratification, minimisation, and adaptive designs.
- Supply chain integration with depot management and automated re-supply.
- Proven uptime, change control speed, and amendment response time.
Where shortlists fail
IRT/RTSM shortlists weaken when sponsors choose based on brand familiarity without testing implementation complexity and operational responsiveness.
- Choosing a vendor that requires extensive custom build for standard randomisation designs.
- Underestimating the cost and timeline of protocol amendments on IRT configuration.
- Assuming uptime SLAs reflect actual measured performance.
Use CVC
Compare irt/rtsm vendors with more structure.
Use the vendor directory to build a shortlist, then use sponsor support if the final process needs more pressure-testing.
Related guide
Best eClinical vendor for biotech
For broader eClinical technology vendor comparison, see the eClinical guide.
Read the related guide