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Randomization & Trial Supply Management (RTSM)

Easily support all your protocol designs with Bioclinica RTSM

According to a 2020 IRT report conducted by ISR, sponsors and CROs want an RTSM 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 that has experience across the range of trial demands is important, particularly as today’s trials involve more patients, sites, countries and uncertainty than ever before. The number and complexity of issues affecting randomization and supply chains 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.

Benefits

  • End-to-End Solution

  • Ease of Integration

  • Rapid Deployment

  • Reduced Cost of Ownership

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Bioclinica offers the industry’s only purpose-built, end-to-end, configurable RTSM solution. Together, Bioclinica 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.

People and digital tech

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 Bioclinica’s leading clinical trial technologies such as Bioclinica EDC and Bioclinica CTMS as well as nearly all third-party EDC, CTMS and CSIM systems.

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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, Bioclinica 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.

Take advantage of our competitive and predictable pricing model to reduce the overall cost of RTSM ownership. Yet, don’t compromise. We know flexibility is key. That’s why we designed the Bioclinica RTSM to be supported by your services partner and/or your own staff, or you can leverage Bioclinica’s in-house RTSM service delivery expertise.

How It Works

Ensure there is enough medication at a site to assign to a subject

Bioclinica’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. 

  • Study Build

  • Randomization

  • Drug Dispensing

  • Database Lock

  • Reconciliation & Destruction

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Build, implement, test and deploy protocols within a few weeks, with an integrated supply strategy.

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Conduct fast, accurate subject randomization based on protocol design. In addition to initial randomization, Bioclinica IRT also allows you to:

  • Re-randomize subjects into another treatment arm for another study phase.
  • Randomize another study subject into a treatment group to replace dropped participants without disrupting study balance.
  • Support extension studies, rolling overqualified subjects from one study to another.

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Implement integrated, optimized IRT design to get the right drugs to the right sites and subjects at the right time. Built-in alerts and notifications provide proactive tools that help bridge the gap between sites and supply chain management. Adaptive study design, temperature-controlled supply management and drug accountability are standard features.

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Be able to lock studies quickly and with confidence knowing your randomization was precisely executed and any data collected is of the highest quality.

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Reduce time, effort, and cost through continually updated supply plan and reduced waste. Bioclinica’s IRT is tailored to visit-specific strata, making it easy to manage complex dosing scenarios. Because it is configurable for predictive re-supply based on actual demand, it eliminates drug supply over-stocks and stock-outs. Additional value-added features include:

  • Controlled substance inventory management tool providing tracking and monitoring at the pill level. Set customizable site inventory limit controls, shipment restrictions and threshold alerts. Track medication status along the entire supply chain and know whether it was taken, disposed, lost, destroyed or returned.
  • Drug pooling functionality minimizing drug waste and eliminating unnecessary labeling costs.
  • Management of clinical supplies based on actual usage and forecasting consumption through Bioclinica TSO to significantly minimize waste and reduce costs.

Achieve more predictable timelines and higher quality data with Trial Supply Optimization

Bioclinica’s 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 Bioclinica’s 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

  • Complete Study Simulations

  • Reforecast & Optimize

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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.

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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

Bioclinica’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 Bioclinica Medical Imaging, Bioclinica EDC and Bioclinica 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
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Bioclinica’s IRT reduces the average set up time 50 to 75 percent compared to IRT systems built from the ground up for each new study.

VIEW CASE STUDY
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We’d love to discuss YOUR RTSM CHALLENGES WITH YOU.