Easily support all your protocol designs with Mentor RTSM
Sitero offers a purpose-built, end-to-end, configurable Randomization and Trial Supply Management (RTSM) solution. It covers the full cycle of supply management from planning and forecasting, through inventory management according to the requirements in the protocol, management of any temperature event, and finally reconciling the drug inventory and destroying remaining medication at the end of the study.
The number and complexity of issues affecting RTSM has grown to include costly comparator drugs, intricate protocols, delicate investigative compounds, adaptive clinical trials, and variable dosing schemes. Adding to the mix are increased regulation and country-specific approvals surrounding temperature-controlled drugs, packaging, shipping, and labeling.
Mentor RTSM Benefits
Rapid Development
Take weeks, not months, to build, implement, test, and deploy new protocols using our agile development approach. Implement protocol amendments in days, not weeks. How do we do it? We don’t start from zero. Instead, Sitero IRT relies on built-in configurations as the base for every project. Because the programming is already done at the start, little or no system development effort is required — for study start-up or to accommodate mid-study changes.
Improved speed & quality through agile delivery
- Parallel build and specification
- Prototype solution ready for demonstration to clinical team
- Fewer URS iterations and UAT findings
- Study implementation within 4-5 weeks from kickoff
Trial Supply Optimization
Achieve more predictable timelines and higher quality data
Sitero’s Trial Supply Optimization (TSO) is a forecasting and management software that lets you quickly and easily create and compare supply scenarios against trial objectives, such as schedule, cost, and feasibility.
This determines your optimum supply strategy — reducing drug waste and study costs by millions of dollars. Sitero’s TSO integrates with Sitero’s IRT software so you can identify and adjust enrollment rates and supply needs based on trial actuals.
Plan & Forecast Clinical Supply Scenarios
Create and compare supply scenarios against trial objectives (e.g. schedule, cost, feasibility) to determine the optimum supply strategy. Use Monte Carlo methodologies to forecast supply and demand for clinical supplies as well as risk of stock-outs for any clinical supply plan.
TSO models unpredictable demand over time and uses this information to calculate drug quantity and when and where to ship it. Reforecast & Optimize: Utilize continually updated trial actuals in an integrated RTSM study to quickly identify and adjust enrollment rates and supply needs.
