Specifications include, but are not limited to: UIHC is seeking a workflow management product to automate managing investigational drug studies for up to 400 protocols. The following functionality is sought from the investigational drug services product that is desired: Protocol management: Integration with the OnCore clinical trial management system to receive protocols and study subject information ꞏ Ability to handle multi-arm (platform or umbrella) studies Ability to pull information directly from clinicaltrials.gov Compliance and security: Audit log tracks all changes to system, is reportable, and documentation cannot be erased or changed System access granted by role and limited to specific protocol Training tracked for personnel Inventory management: Low inventory alerts Lot number and expiration date tracking Electronic drug accountability records Inventory tied to dispense Chain of custody documentation Study monitor management: Ability to schedule and manage study monitor visits Ability to grant appropriate limited access to information to study monitors so IDS staff doesn’t have to retrieve and/or send information for them Billing: Custom billing supported Ability to send invoices from system Documentation: Temperature excursion tracking and documentation Ability to upload documents and attach to specific study/protocol Integrations desired: OnCore clinical trials management system Epic – to receive patient information and gain efficiencies with drug record build Vendor/system support: 24/7 support from staff with pharmacy/IDS expertise Onsite support for implementation System optimization during and post implementation Ongoing training