A message from the UNC Network for Research Professionals Listserv:
Dear Clinical Research Community,
UNC Health’s Investigational Drug Services (IDS) will be relocating to a new facility on Page Road in Fall 2024. This decision stems from the recognition of significant capacity limitations and operational challenges within current space, necessitating a move to facilitate continued growth for current and future needs and to enhance operational efficiency. The new facility will offer continued growth in production, storage, and distribution capabilities and enable IDS to meet study sterile compounding requirements. This relocation will be an opportunity for IDS Pharmacy to better support the needs of not only research conducted at UNC Hospitals but also at other entities across the UNC Health system.
We recognize that the relocation of IDS’s hub will require ongoing communication, coordination, and collaboration. One UNC Clinical Research leadership (with engagement from various clinical research stakeholders) and IDS leadership are partnering closely to ensure a comprehensive understanding of all potential impacts to clinical research (e.g. related to timing, delivery, costs, sponsor engagement, etc.), as well as IDS operational and compliance requirements.
Please note the following:
- We will soon be distributing a survey to collect specific operational and regulatory details about all active IDS studies to inform planning for providing products following the IDS move. Assessing this information now will ensure IDS is prepared to support any conditions that may be required by specific studies and/or products.
- IDS will continue to operate as a hub-and-spoke model with the hub newly based at Page Road; and IDS will maintain support and collaboration with local pharmacies including Eastwone, UNC Hillsborough, Rex, Cary, Wakefield, Nash, Children’s Raleigh, with opportunities to expand to additional locations.
- IDS will establish a local “spoke” for receiving and distributing products at the UNC Chapel Hill hospital. The UNC Chapel Hill hospital IDS spoke staff will ensure appropriate receipt of products from the Page Road hub, complete required documentations (e.g. temperature logs), maintain chain of custody, and manage all logistics for daily distribution of products.
- IDS will have products couriered to the UNC Chapel Hill hospital spoke at scheduled intervals and with a direct courier route based upon study needs. We recognize there will be specific requirements for some products, which will be assessed via the survey.
- No additional costs related to courier services will be applied to current/active studies receiving drug at the UNC Chapel Hill hospital through FY25. IDS and One UNC Clinical Research leaders will continue to evaluate needs and operating models and any future changes will be communicated with advance notice of such changes.
- IDS and One UNC Clinical Research are beginning to explore establishing a service level agreement between UNC Health and the University to ensure ongoing optimization of processes and abilities related to managing investigational products for research.
We will continue to engage stakeholders to inform this initiative and will provide further updates as they become available. Please be assured that we will work to ensure any potential impacts to clinical research are fully understood and appropriately managed or mitigated.
If you have any questions or concerns, feel free to contact us directly.
Thank you,
One UNC Clinical Research
UNC Chapel Hill & UNC Health