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Optimizer

Bioclinica's Optimizer 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, to determine your optimum supply strategy – reducing drug waste and study costs by millions of dollars. And Optimizer's integration with Bioclinica's Trident Agile IRT software means you can identify and adjust enrollment rates and supply needs based on trial actuals, helping you get to database lock faster, with significantly lower cost and effort, and with higher-quality data.

Clinical Supply Chain Forecasting, Simulation and Optimization

Optimizer is Bioclinica's powerful forecasting and demand planning technology used by the world's largest pharmaceutical companies to manage global logistics of the clinical supply chain. Managing supplies based on demand creates opportunities for savings and efficiencies in numerous areas, eliminating the high cost of waste as well as shortages that threaten timelines, budgets and even study integrity.

Today's trials involve more patients, more sites, more countries and more uncertainty than ever before. The number and complexity of issues affecting 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.

Challenging study variables and supply chain factors like these are difficult to manually manage and impossible to forecast using spreadsheets. And when the unexpected happens, whether underestimated country enrollment or an enrollment spike for instance, it can take significant human intervention and monetary resources to correct in time.

Clinical trial professional Buz Hillman explains how his team uses Optimizer
to more accurately predict their supply needs. Read his blog here.

 

Simulate Real-World Demand Scenarios

Simulation enables planners to identify and mitigate potential supply crises at a global and site level before they happen. When live study data is imported, it allows for stock adjustments to be made, reducing the occurrence of mismatched clinical supplies and demand. It also eliminates associated costs of shipping overruns and subjects lost due to stock outs.

Optimizer maximizes study efficiency and minimizes costs, even for studies involving supplies with special dosing or handling requirements, such as complicated titration, multi-variable dosing, comparators, temperature-sensitive drugs, limited supply situations, and other variables. Effectively managing this level of complexity can avert crises that lead to delayed studies and subject loss.

Optimizer models unpredictable demand over time and uses this information to calculate drug quantity and when and where to ship it. 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.

Optimizer Enterprise Suite

As planning needs vary dependent on protocol complexity, whether at the single study or in-depth program level, Bioclinica now offers the most advanced clinical supply simulation tools in both a web and a desktop solution to fit any organization's need.

Optimizer Direct: Streamlined Web-Based Solution

Essential supplies forecasting and planning with straightforward modeling and forecasting ideal for smaller-scale or stand-alone studies

  • Point-and-click with color-coded sequence to guide model setup
  • Simulate the most common scenarios (define treatment groups, dispensing units/kits, study visit schedules)
  • Get a snapshot view of your forecasts complete with charts and graphs
  • Give the entire supply team online access to plans and data

Optimizer Advanced: High-Power Desktop Solution

Extended forecasting and planning ideal for large-scale programs and complex studies

  • Sophisticated modeling to run multiple scenarios with different variables (Monte Carlo simulation)
  • Expanded reports, customizations and extensive drill-down capability
  • Determine the best shipping method based on cost, package size, resupply timeline, international tracking, and other factors
  • Do complex kit configurations including investigative compounds, devices, and instructions
  • Simulate multiple study drug pooling
  • Redistribute supplies among depots in an emergency
  • Native Integration with Trident and third-party IRT systems

Optimizer Aggregator: Enterprise Demand Planning Module

Assemble cross-study clinical supplies information in a single, cohesive planning system

  • Connect people and processes, enabling informed decisions for the utmost confidence in the broader supply chain
  • Make purchasing choices based on an optimized global plan
  • Combine demand forecasts with manufacturing bill of materials, process, efficiency goals and timelines to determine the manufacturing and packaging plan at all material levels

Web accessible tool

  • Forecast the supply chain across ALL STUDIES to any level you desire, from Finished Goods to API
  • Know how much drug to manufacture, package, and/or purchase
  • Collaborative environment makes it easy to share plans with peers, partners, customers and management

Flexible Deployment Options

Bioclinica offers a hybrid service plan tailored to your needs, whether one piece of the supply chain puzzle or optimization at a study or program level. If you choose, Bioclinica will forecast supply needs, run simulations, and develop a comprehensive plan with your input. Our team builds models and scenarios using Optimizer Advanced. As a study progresses, our team can revisit forecasts using latest actuals from IRT systems and alert you of changes as well as potential complications.

Select Service Options Right for You:

  • Forecasting
  • Program Level Optimization
  • Full Supply Chain Optimization & Planning

 

 

Simply log into the web application to view and interact with models and forecasts. Toggle between data views to see program and protocol level forecasts spanning different timeframes.

Optimizer Resources

White Papers

Optimizing Your Supply Chain Management

The drug supply chain is becoming more uncertain and complex because of the inclusion of more patients, at more sites and in more countries; country-specific regulations and approvals for temperature-controlled drugs, packaging, labeling and logistics; and more intricate protocols.

Blogs

The Value of Protocol Review

One of our strategic customers recently invited me to review a draft protocol synopsis for a pivotal Phase III registration study. As the provider of the randomization and trial supply management (RTSM) solution  for the study, I relished the opportunity.

CTMS and RBM: Hot Topics at OCT Nordics in Copenhagen

The 5th Annual Outsourcing in Clinical Trials (OCT) Nordics conference provided another outstanding opportunity to explore a beautiful city, stay in the world’s greenest hotel and gain additional insight into aspects of clinical trials that are important for my daily work and even thos

Join us for our upcoming webinar on September 13th during which Bioclinica experts Senior Director of RTSM Operations and Commercial Solutions, and Robin Barber, Manager of R

ADDITIONAL RESOURCES

Bioclinica Agile RTSM

Download Overview Sheet

Optimizer Pillars of Success

Download Overview Sheet

eHealth Patient Journey

Download Infographic

Optimizing Your Supply Chain Management

Download eBook

Leader in Clinical Trial
Management Solutions

Bioclinica is organized into three business segments so that we can provide expert service and multifaceted technologies. Our Medical Imaging & Biomarkers segment includes an Imaging Core Lab, a Cardiovascular Safety division, and a Molecular Marker Laboratory. Our eHealth segment comprises eClinical Solutions, Randomization & Trial Supply Management, Safety & Regulatory Solutions, and Financial Lifecycle Solutions. Under the Global Clinical Research segment, we offer a network of research sites, patient recruitment, and a Post-Approval Research division.

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Latest Blogs:

Removing Risk from Clinical Trial Management System (CTMS) Implementations
Collaboration Between Clinical Operations and the Logistics and Supply Chain Teams is Key to Trial Success
The Value of Protocol Review
CTMS and RBM: Hot Topics at OCT Nordics in Copenhagen
Congressman Meehan and Bioclinica CEO John Hubbard at recent visit to Bioclinica's Audubon offices