Setup of a tech-support helpdesk, training materials and anything else needed by clinical trial sites, study coordinators and participants.
PillTracker will manage the delivery of the above with a 3rd party vendor, [****] Group, and in collaboration with the appointed CRO (Prevail infoWorks) and NeuroRx.
PillTracker will directly pay [****] for activities that it will directly supervise, excluded are transportation and local duties.
Cost of this service is $ [****], as quoted in Appendix 2, and is optional additional work which can be activated at NeuroRx’s written request.
Service can be activated via purchase order, supplemental task order or in writing via email. Service can be managed via passthrough cost or directly between NeuroRx and the 3rd-party vendor.
Pre-study Procurement and Staging
Deployment, staging and preparation of all hardware and related support services, including:
|1.||Procurement of medical devices, cellular-connected tablets, ancillaries, and disposables|
|2.||Setup of individual kits for each clinical trial participant, a mobile device management system (MDM) to support devices in the field, and a system for deprovisioning, reprovisioning, recalls and replacements|
|3.||Devices will be procured upon issuance of Purchase Order according to the terms of PQ ZYS-0003|
Devices will be ordered separately. All pricing is quoted in ZYS-0003 and provided in Appendix 2. Devices required for purchase, separately, include:
|●||Oxitone 1000M Pulse Oximeter|
|●||Pocket Neb Mesh Nebulizer|
|o||Standard, without data capture|
|●||Spare medication cups for pocket neb|
|●||Unifying hub, including Samsung Galaxy Tab A and ancillary parts, and ability to link to Oxitone and data-capture pocket neb, and with ability to host PillTracker’s patient interface and other necessary applications.|
Oxitone 1000M pulse oximeters must be purchased via passthrough due to software integration and setup requirements
PillTracker Hub and Pocket Neb can be purchased passthrough via PillTracker or via direct order with supplier.