LABCORP ENDPOINT CLINICAL INC.
DURHAM, NC

PULSE, endpoint’s proprietary rules-based core engine, redefines IRT by delivering greater speed, flexibility and control so you can confidently manage your clinical trial and supply chain in real time. It enables rapid development of a customized and validated IRT system that allows you to monitor study data and access administrative tools on a mobile platform, meeting all your trial design needs at a much lower cost than other providers and in a fraction of the time. 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. 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. 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. 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 submissions or updates. Certain low-risk changes can be made automatically by the system if mutually agreed upon by endpoint and the trial sponsor. Building a stand-alone, fully functional IRT system for every clinical trial study is not necessary, but without one, you may be forced to run your Phase I, IV and Investigator Sponsored Trials manually. DRIVE delivers the benefits of IRT supplies management to your entire development program in one system, enabling automated IRT-like supply functionality that minimizes costs, reduces waste and helps you manage regulations across 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. Our message center, powered by NUDGE, provides convenient access to all your study confirmation messages for the duration of your project. You can print and save messages, and resend or retrigger messages within your study portal site following a data change to ensure that the latest data is communicated. NUDGE also lets you send messages directly to an individual’s or group’s endpoint portal study website, ensuring recipients complete important actions to help your study stay on schedule. 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. Quality Philosophy 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. At our core is a commitment to the continuous evolution and enhancement of IRT to improve your trial management. Our unique, single-focus approach makes endpoint the only company with the knowledge and experience needed to drive IRT and e-clinical integration paradigm shifts in the industry.