PULSE® Enterprise-level IRT Management Platform
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.
At a Glance
- Randomization and Trial Supply Management (RTSM)
- Readily configurable to a variety of trial designs
- Standardized integration paths with other eClinical technologies
- Robust trial administration tools to manage sites, users, and supplies
- Wide-ranging reporting tools with ad-hoc capabilities
- Developed, supported, and maintained by customer-obsessed Endpoint Clinical professionals
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.
The PULSE platform allows you to manage a broad range of standard and customized randomization methods, supporting even your most complex clinical trial designs. The platform also supports cohort management, the ability to add and drop treatment arms mid-stream, accommodation of randomization replacements and other potentially complex randomization-related IRT design components.
Drug Supply Management
Manage every aspect of your inventory supply chain through access to real-time reports and configurable supply parameters within PULSE. The platform’s advanced algorithms allow you to deliver the right drug at the right time for both new and existing subjects — without interruption and while balancing waste and cost. Extend the power of PULSE to your study team so that you can respond quickly to supply chain updates. Our robust supply management tools enable management of threshold and predictive settings, batch release, country approvals, temperature excursions, and expiration management through the Endpoint Clinical portal.
The full-featured and configurable site management tools in PULSE give you real-time access to manage important details for each site, including site contact information, site status (activate/deactivate), site supply settings, and screening and enrollment limits. Provide operational transparency across your sites through the entire course of a study with real-time web reports that track shipments to sites and monitor both site-supply levels and subject activity.
Improve communication, increase compliance, and ensure your studies remain on track with the study management tools in PULSE. Use them to make data changes online, open and close study modules, and update inventory settings on the fly. All users have the ability to manage their study alerts and messages for the duration of the study via NUDGE™, our message center. Automatically generate customized messages that can be sent directly to sites and patients through the portal or use the ad hoc report builder to create and share web reports with other users for immediate access to your study information.
Customize the PULSE platform to support the 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 (email, fax, SMS) give you ready access to compliance feedback for continuous transparency of your study’s progress.
PULSE also supports all standard data transfer formats, including web services (SOAP), XML, .txt, ASCII, CSV and SAS. Use it to synchronize both inbound and outbound data, whether event-based, schedule-driven or on-demand. The PULSE platform supports integrations in its UAT environments to provide full test-transfer capabilities.
Electronic Data Reconciliation System (eDRS™)
Endpoint Clinical’s electronic data reconciliation system, or eDRS, provides an online solution to request, review, and approve data-change updates throughout 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. Each request generates a unique online ticket and requires an electronic signature for submissions or updates. Certain low-risk changes can be made automatically by the system if mutually agreed upon by Endpoint Clinical and the trial sponsor.
Investigator Access to IRT Audit Log Data in a Secure, GXP Compliant Platform
To maintain data oversight and ensure integrity, Health Authority guidelines require IRT audit log data to come directly to investigators without sponsors handling or managing the data in the process. To meet this requirement, IRT vendors must facilitate Investigator access to system audit logs post study close, outside the IRT system.
Driven by this new regulatory guidance and industry need, Endpoint Clinical and partner, Egnyte™, have created the DIAL Audit Data Management platform – a validated IRT system integration that extracts IRT transaction audit log data for each site and provides these data files to Investigators directly in a GXP-compliant and secure platform. Thus, ensuring Investigators have the data they need to meet regulatory expectations.