Is the Clinical Supply Function Overlooked in Clinical Trial Management?
Pharmaceutical Business Conference Group’s COG series of events focus on a range of topics, including outsourcing, patient engagement, trial design, regional considerations, and clinical supply…. to name just a few!
A quick search of LinkedIn shows 29,000 professionals in clinical supply functions, verse 247,000 in clinical operations. A majority of those sitting in supply functions belong in large Biopharma organisations, or CROs/ Vendors.
In today’s complex clinical trial ecosystem, supply logistics cannot be an afterthought. Careful clinical supply planning and management is essential for delivering high quality trials on time and on budget.
The supply function refers to the procurement, storage, and movement of the investigational pharmaceutical products or medical devices being tested in a clinical trial setting. Clinical supply chain activities are critically important for conducting robust and compliant trials.
Sufficient quantities of the investigational product must be produced and obtained to supply all trial sites for the duration of the study. Underestimating supply needs can lead to issues producing more product if stocks run low. This risks causing trial delays and disruptions that impact timelines and budgets. Careful forecasting of supply requirements is essential.
Storage, packaging, labelling and temperature-controlled shipping of clinical products is also vital. For example, a simple labelling error can invalidate product batches. Lapses in temperature-control can ruin an entire supply chain. Robust processes for supply logistics must be implemented to safeguard product quality.
Inventory management and reconciliation of used and unused investigational product provides oversight and ensures no losses, fraud, and/or mistakes. Meticulously tracking supply inventory also allows for accurate reordering and planning for future supply needs as the trial progresses.
Poor supply chain management has serious regulatory implications, where if not correctly conducted can result in trial data being refused by regulatory bodies. Dedicated expertise is required to manage clinical supplies and prevent compliance issues that would be detrimental to trial results.
Whilst there are significantly less clinical supply job roles in the public domain, I do not feel this is a neglected area. Across the COG series we welcome many clinical supply specific vendors, indicating that this is a heavily outsourced part of the overall clinical trial management function. Due to it's complexity and regulatory implications, trial sponsors are more likely to outsource the supply and logistics function to a specialist provider, or have this service included by their full-service CRO.
Clinical supply challenges and innovations will be showcased at the two upcoming events in H2 2023: