Product Overview
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.
Deployment
- Web based
- Cloud Hosted
Pricing
- Subscription
- License Fee
More Information
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.
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.
About the company
Today, Sitero is a next-generation clinical trial solutions partner, working with more than 200 Pharmaceutical, Biotech, and Institutional Research Organizations globally. Sitero uses technology to drive safety, compliance, quality, and efficiency in research and clinical trials, so customers can bring life-changing treatments to market safer and faster.
With leaders in Technology, Clinical Operations, Biosafety, Drug Safety, Ethical Review / IRB, and more, Sitero draws on a deep well of knowledge to build solutions for customers. As a technology and service-oriented partner, Sitero focuses on forging strong relationships that can drive efficiency by leveraging next-generation software.
The company’s continued innovation is driven by its core mission: To advance clinical research with a next-generation, technology-enabled delivery model.