The complexity of clinical trials requires technologies that give clinical supplies professionals full visibility, traceability, and control of inventory at the manufacturing, depot, site, and patient levels. DRIVE exists to satisfy those needs.
DRIVE’s advanced configuration functionality gives you the flexibility to manage important elements of your supply chain in a proactive manner.
This functionality enables users to add, edit, and delete clinical programs from DRIVE. It also gives users the ability to group protocols together by program for management and reporting.
Facilitates users of DRIVE to configure the setup of a protocol including management of kit types, countries, depots, resupply, product returns, and sourcing settings.
Empowers users to manage a global list of kit types that can be pooled and used across multiple programs and studies. Users can also manage control parameters, controlled substances, and package multiple components within the bill of materials using kit configuration functionality in DRIVE.
Use DRIVE to better manage supplies across depots and sites to assure that the right product is at the right place at the right time.
Users can add, edit, and delete depots from DRIVE with a few clicks of a mouse. By using this functionality users can manage a list of depots across protocols. This functionality also supports setting up return depots, supply depots, and central pharmacies — all inside DRIVE.
Facilitates end-user management of the packaging and release process for inventory across all protocols and drug pools. Also tracks the manufacturing process from physical depot inventory brite stock through the labeling, drug serialization, and expiry management processes (initial and over labeling), country approval, and status management. This functionality makes drug pooling easier by empowering a user to approve inventory for specific protocols and countries flexibly in real-time.
Improve the site and patient experience by using DRIVE’s advanced site management functionality.
This functionality enables sponsors to configure the setup of sites, including managing product returns, addresses, resupply, and sourcing setups.
This functionality empowers users to manage inventory at the site — supporting kit status management, dispensation, and over labeling/expiry extensions.
Take advantage of DRIVE’s ability to manage manual shipments, shipment requests and approvals, as well as manage distribution across depots and sites.
This functionality enables users to manage the manual shipping process for depot-depot, depot-central pharmacy, and depot-site shipments. It permits them to build and configure each individual shipment with the ability to select serialized/bulk kits and specify exactly what needs to be sent.
Built to support the workflow of investigator-initiated trials, this functionality helps sponsors request IP from suppliers. The IP provider sets up controls to enforce limits and identify selectable kit types on a per-protocol basis.
Facilitates supplying the IP required to approve shipment requests from sites. Also provides the capability to approve, decline, and adjust requests to ensure accurate stock levels at the site.
Makes it easy for users to support the dispatch, cancellation, and receipt processes for all generated shipments to manage depot-site and depot-depot shipments.
Choose from a variety of standard reports or create ad-hoc and custom reports using DRIVE’s advanced reporting functionality.
Clinical trial professionals can easily create ad-hoc, custom (including data visualizations) and traditional reports using DRIVE. Users can choose to build their own or select from a standard set of pre-configured reports, all of which access application data.
Leverage a suite of messaging tools using endpoint’s NUDGE™ technology to document actions and remind you to conduct important clinical supplies management tasks.
DRIVE’s message center, powered by NUDGE, provides convenient access to all your study confirmation messages during your project. You can print and save as well as 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 your endpoint study portal, ensuring recipients complete important actions to help your study stay on schedule.
Facilitate end-user returns by using DRIVE’s state-of-the art returns management functionality to guide product returns, accountability, inspections, and more.
This is a configurable workflow allowing for accountability, verification, inspection, as well as site and depot level destruction. Users choose from different configurations that support kit/content level inspection, controlled/non-controlled workflows, and more.
Integrate seamlessly with third-party platforms (including clinical supply, lab, registry, EDC and CTMS), with each other, and with your own proprietary systems.
To ease the burden of data integration for trial sponsors, endpoint developed DRIVE to integrate with any technology. By partnering with clients early in the system’s development endpoint assures that all integrations are ready once a study begins.
Stay connected to your clinical trials via an Android, iOS smartphone or tablet.
DRIVE’s mobile-optimized interface gives you access to study data and administrative tools, helping you monitor your study’s progress, adjust parameters, and make critical decisions in real time using mobile devices.
Extend the power of DRIVE to your entire study team with fully-featured and configurable study management tools.
DRIVE’s 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 devices.
Remain compliant with FDA and EU regulations, including 21 CFR Part 11 and GxPs, with endpoint’s quality management system (QMS) framework.
endpoint’s quality assurance team regularly reviews our technology 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.
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