Managing sites, patients, drug supplies and study data during a clinical trial is a challenging undertaking. Before choosing your IRT partner, you need to ask:
endpoint meets your demands so you can confidently manage your clinical trial and supply chain in real time. Our systems are truly the most intuitive and cost-effective solutions on the market. You can trust endpoint to capture and monitor your critical data and keep your clinical trial on point.
Read more about our system features below.
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.
Manage every aspect of your inventory supply chain though 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 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.
Rapidly deploy your electronic patient reported outcomes (ePRO) solution using the highly configurable, modular interface provided by PULSE. ePRO data can be incorporated into the overall flow of your study, giving subjects the option to conveniently record diary entries by phone (IVR), browser (IWR) or mobile device (IMR), thus minimizing disruption to their daily activities and increasing compliance. By integrating PULSE with ePRO, you will provide a patient-centered experience while eliminating the high overhead associated with device procurement and management. PULSE provides integrated, real-time compliance monitoring tools, including web reports and diary reminders via email, SMS and voice call. It also automatically triggers alert messages for immediate follow-up with non-compliant patients. Randomized studies with ePRO or diary components can be easily integrated using the PULSE platform to enable full randomization and supply management IRT services for your ePRO trials.
PULSE also supports all standard data transfer formats, including web services (SOAP), XML, .txt, ASCII, CSV and SAS. We can synchronize inbound and outbound data, whether event-based, schedule-driven or on-demand. endpoint supports integrations in its UAT environments to provide full test-transfer capabilities.
endpoint’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 submission or update. Certain low-risk changes can be made automatically by the system if mutually agreed upon by endpoint and the trial sponsor.
Both DRIVE and PULSE are designed to integrate seamlessly with third-party platforms (including clinical supply, lab, registry, EDC and CTMS), with each other, and with your own, homegrown system. In fact, approximately 90 percent of endpoint IRT systems are combined with at least one partner system. For example, the PULSE platform adheres to CDISC open data standards to ensure the quality, efficiency and cost-effectiveness of your clinical research processes.
Configure and deploy your own IRT system with our software-as-a service (SaaS) model. Our user-friendly SaaS option is the first to address the varying levels of technology, expertise and IRT knowledge in pharmaceutical and biotechnology companies. The SaaS is available for license to all certified endpoint customers, and gives you complete control and flexibility in designing your own flexible, affordable, high-quality solution.
Stay connected to your clinical trials via an Android or iOS smartphone or tablet. Our system’s mobile-optimized interface gives you access to study data and administrative tools on a single platform, allowing you to monitor your study’s progress, adjust parameters and make critical decisions in real time. If you choose PULSE, the mobile capabilities include extended IRT functionality, such as the ability to record patient visits, manage study limits, modify supply strategies, review and approve shipments, and activate and deactivate sites.
Extend the power of PULSE and DRIVE to your entire study team with our full-featured and configurable study management tools and real-time web reports. Simple and intuitive web pages provide role-based access and make it easy to manage users, sites, permissions and supply settings at the study, region, country and site levels. Access these features anytime, anywhere on your mobile platform.
Keep your studies in compliance with FDA regulations, including 21 CFR Part 11 and GxPs as well as EU regulations, with our quality management system (QMS) framework. Our quality assurance team regularly reviews endpoint products and operations to ensure consistency with regulatory requirements and maintain the efficacy of our quality systems. These activities include project debriefs, internal audits, a robust CAPA management system, extensive training, and regular management reviews. endpoint also supports your vendor audit process by offering virtual or on-site audits upon request.
You can be confident the appropriate processes, procedures, training, quality oversight and tools are available to support your employees in delivering superior products on a regular basis. Our approach to quality is holistic and emphasizes quality from day one. We always strive to successfully scale our operations, while enhancing the quality of your experience across the board.
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