PULSE® was designed to be more flexible, easier to modify, and quicker to develop than any other IRT system on the market. Although clinical trials have become more complex, managing them should be simple.

PULSE is made up of pre-validated, configurable study components that enable rapid development and quicker modification to your IRT system. Building your system with PULSE will streamline complex trial randomization methods, improve your drug supply management, and simplify site, study, and subject management. The fully digital, mobile-ready system will also allow you to access patient data and outcomes in real time.

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PULSE is a dynamic IRT solution for your comprehensive trial needs.

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Benefits of PULSE

Building your IRT system on PULSE allows you to take back control of complex processes. The reporting and messaging functionality helps stakeholders perform day-to-day tasks more efficiently and cost-effectively. Using PULSE to build a customizable IRT system will:

Accelerate Study Startup Begin using your custom-built IRT system in just one month. The PULSE software platform allows you to configure personalized solutions, no matter what the complexity, without sacrificing quality.

Add FlexibilityUse the pre-validated, configurable study components to develop and modify your IRT system in PULSE.

Gain Mobile Control PULSE delivers real-time access to study data and administrative tools via a mobile-optimized interface that gives you the power to monitor your study’s progress and make critical decisions.

PULSE is designed to refine day-to-day trial operations and patient data management.

PULSE Functionality

Trial Randomization Manage a broad range of standard and customized randomization methods, supporting even the most complex trial designs.

• List-based, dynamic, adaptive• Cohort management • Add/drop treatment arms • No limit to stratification factor count

Drug Supply Management Manage every aspect of your inventory supply chain through access to real-time web reports and configurable supply settings.

• Supply Chain Reports View detailed real-time status of supplies, shipments, and kits.

• Shipments Manage automated initiation, tracking, receipt, and temperature excursion.

• Drug Release and Country Approval Designate unique lots of available drug to ship to designated locations.

• Expiry Management Manage lot assignment and expiry data.

• Forecasting Identify upcoming supply needs with configurable web reports.

• Accountability Supplies accountability through destruction.

• Integration Integrate depot, site, and subject data for automated depot fulfillment.

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PULSE is supported by a team of inspired endpoint developers, project managers, and help desk personnel.

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PULSE Functionality Site Management The full-featured and configurable site management tools in PULSE give you real-time access to manage import details for each site, including site contact information, site status (activate/deactivate), site supply setting, and screening and enrollment limits.

Study Management Improve communication, increase compliance, and ensure your studies remain on track with the study management tools in PULSE.

• Configurable study settings • Online data changes • Open/close study modules • Update inventory settings • Monitor site compliance • Message center and endpoint NUDGE™

Subject Management Customize the PULSE platform to support complex visit and dosing schedules found in your trial designs. Use the system to track subject activities in real time throughout all your study visits and milestones. The real-time web reports and NUDGE alerts platform give you ready access to compliance feedback for continuous transparency of your study’s progress.

Reporting The endpoint study portal provides powerful, multi-level access to reports for sponsors, sites, and subjects. The study portal contains a next-generation reporting platform with the capability to provide customized real-time exportable reports while surfacing any data point of your choosing.

Report Highlights• Study summary• Depot summary and detail • Site summary and detail • Supply summary and detail • Subject summary and detail • Shipment summary and detail • Kit assignment history • Compliance reporting: ePRO• Drug reconciliation management reports• Global reporting: programs or multiple studies

Electronic Data Reconciliation System™ endpoint’s electronic data reconciliation system, or eDRS, provides an online solution to request, review, and approve data-change updates through the course of your study. eDRS helps you move previously paper-only processes to an online solution, complete with real-time reporting and alerts. Your research sites will be able to submit and track data requests and be notified upon implementation.

PULSE redefines IRT by delivering greater speed, flexibility, and control so you can confidently manage your clinical trial and supply chain in real time.

Discover how you can create your ideal IRT experience with our customizable solution.