StudyOptimizer

StudyOptimizer is a web-based solution that helps life sciences companies deliver clinical trials on time and on budget by automating the process of planning and tracking patient enrollment. Leveraging advanced predictive analytics and compelling data visualizations, study teams can monitor actual and projected enrollment in near real-time, gaining timely insight into potential problems and prevent them before they occur.

Enrollment Planning

StudyOptimizer allows Study Managers to leverage the information that resides in their organizations by looking at historical enrollment data and creating plans that reflect these metrics. For larger, global trials, study managers in different locations can work collaboratively, so that they can build in the assumptions and enrollment behaviors for their specific geographies. Multiple plans can be created and tested against each other to identify the approach that optimizes the overall delivery timing and cost of the clinical trial. Features include:

  • Collaborate globally on plan creation
  • Leverage historical data in an automated fashion
  • Define comprehensive country plans
  • Test best-case, worst-case plans before approval
  • Establish a baseline for the study
  • Maintain a record of all plans developed
  • Use a consistent approach across the organization

Enrollment Tracking

For clinical operations executives, StudyOptimizer displays aggregated study data in a single view so you can quickly get information about enrollment status across your entire portfolio. The Runway graph plots the progress of all studies in active enrollment. On an individual study basis, StudyOptimizer provides comprehensive enrollment information in near real-time. The Study view displays site initiation, subject screening, and subject randomization progress for the study, as well as projections of how these key variables will perform beyond today’s date. The Countries and Sites views show enrollment statistics of participating countries and sites, including site initiation, screening, randomization and retention performance. Features include:

  • Track actual performance against the plan in near real-time
  • Monitor enrollment performance at the study,country, and site level
  • Know when enrollment is expected to complete for the study and participating
  • countries
  • Capture recruitment statistics for future use

Enrollment Diagnosis

With StudyOptimizer, you can drill into any performance area, identify which plan assumptions are being violated, and determine how this impacts your forecasted end dates. With all your enrollment information in one place and presented in a very visual manner, it becomes much easier to pinpoint sources of delay. You can quickly assess if sites in a particular country are taking longer to initiate, experiencing large screen failures, or screening patients at a slower rate than other countries.

Enrollment Optimization

StudyOptimizer offers an array of capabilities to model intervention and optimization strategies. It provides a ‘sandbox’ for clinical trial enrollment action planning, where you can model alternatives and create options for adjustments to the plan and see the impact of changes before taking action. StudyOptimizer’s forecasting engine will calculate the impact of those corrective strategies so that you can make informed decisions before deploying them, and have confidence in the decisions you make. And once approved, you can iterate back to tracking actuals against the updated plan, while still having access to the original plan that was the baseline for the study.

DecisionView Platform

StudyOptimizer is built on an enterprise-class Java-based application server architecture designed to deliver the performance and scalability required by a global user base. The server architecture employs a services model to communicate with any standard Web browser, so no proprietary client installation is necessary. StudyOptimizer is offered as either software that can be installed on-premises, or a Software-as-a-Service solution.

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