Focus on Supply Chain Management to Speed Trial Startups
As clinical trial executives continue to look at ways of speeding startup, one item that bears looking at is how clinical supply management is handled.
The ideal time for a clinical supply manager to enter a study is six months or more before the first subject’s enrollment or before the protocol has even been developed, says Reid Tonik, director of clinical supply chain and project management at Catalent.
Sites that do not employ an early supply-chain strategy before protocol development often put unnecessary risk or delay into the trial.
A product’s shelf life is probably the most substantial supply chain factor that needs to be assessed at the outset of a study, Tonik said. “A short shelf life, or one that will be updated and extended several times throughout the study, can dictate the entire supply strategy,” he added. Some products may have shelf lives shorter than that of the trial’s planned duration, which would affect how products will be shipped and stored during the study.
Additionally, expiry date requirements often vary from country to country. An optimal supply management strategy, said Tonik, is aware of and works with expiry labeling requirements of each country to reduce the risk of running into problems during the trial.
Supplies with extreme temperature requirements, such as deep-frozen storage, will often need early and novel solutions to maintaining the product’s viability throughout the trial and up to the time of patient dosing. To reduce the risk of exposing products to adverse conditions that may potentially impact their potency or viability, supply-management systems may wish to consider real-time temperature monitoring of supplies.
In addition, Tonik emphasized the importance of clearly establishing and assigning roles and responsibilities to team members who will oversee specific steps in the clinical supply chain at the start of the trial. A written and agreed-upon Responsible, Accountable, Consulted, and Informed (RACI) document can ensure that management tasks have a defined scope and timing, all with clear ownership and accountability.