According to a 2020 IRT report conducted by ISR, sponsors and CROs want an RTSM for clinical trials that is easy to integrate, can support rapid study start-up and provides the functionality required to meet the level of complexity of their specific trials — at an affordable price.
An RTSM partner for clinical trials that has experience across the range of trial demands is important, particularly as today’s trials involve more patients, sites, countries and more uncertainty than ever before. The number and complexity of issues affecting randomization and supply chain trial management has also grown to include costly comparator drugs, intricate protocols, delicate investigative compounds, adaptive clinical trials and variable dosing schemes. Added to the mix are increased regulation and country-specific approvals surrounding temperature-controlled drugs, packaging, shipping and labeling.
Clario offers the industry’s only purpose-built, end-to-end, configurable RTSM solution. Together, Clario Interactive Response Technology (IRT) and Trial Supply Optimization (TSO) cover 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.
Virtually all of our IRT projects require integration with EDC, and most projects require integration with CTMS. Using either the standard APIs or event-based responses, we’ve integrated with Clario’s leading clinical trial technologies such as Clario EDC and Clario CTMS as well as nearly all third-party EDC, CTMS and CSIM systems.
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, Clario 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.
Clario offers the industry’s only purpose-built, end-to-end, configurable RTSM for clinical trials. Together, Clario Interactive Response Technology (IRT) and Trial Supply Optimization (TSO) cover 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.
How it works
Ensure there is enough medication at a site to assign to a subject
Clario’s IRT simplifies randomization and minimizes study subject allocation bias using proven statistical methods. We use a comprehensive and sophisticated IRT engine that determines the near-term supply-and-demand requirements to make sure that enough medication is available at the site for the immediate needs of dispensing to the subjects.
Achieve more predictable timelines and higher quality data with Trial Supply Optimization
Clario TSO is the industry’s only purpose-built supply 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. And TSO integrates with Clario Agile IRT software so you can identify and adjust enrollment rates and supply needs based on trial actuals.
Our TSO solution provides a longer-term view of the potential medication demand, detecting and highlighting future supply challenges before they become a real-world problem, such as increased demand at a location due to higher than expected recruitment rates or unavailability of a new batch according to the timeline.
Plan & forecast clinical supply scenarios
Create and compare supply scenarios against trial objectives (e.g. schedule, cost, feasibility) to determine the optimum supply strategy.
Plan & forecast clinical supply scenarios
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. Once maximum demand over time is known, minimum stock levels can be adjusted with confidence. Users are able to define floor (product amount needed to cover unpredictable site events) and ceiling (maximum product amount to be sent to a site) resupply settings.
Unified Medical Imaging, EDC & IRT
Clario’s best-in-class integration of medical imaging, EDC and IRT bridges critical aspects in the clinical trial to enable the collection, visibility and management of Clario Medical Imaging, Clario EDC and Clario IRT data and to achieve a harmonious workflow — through a single dashboard.
IRT ↔ EDC
Accelerate your clinical trial with quality data and benefit from:
- Proactive visit-based requests for missing images
- No delays with monthly logs
- No manual reviews/reconciliation and updates
- No data management loads, edit checks and data diagnostics
- Imaging visit dates that facilitate site communications for outstanding data
- Clear view of subject status and subsequent imaging visits