How Do We Ensure Best Practice in the Clinical Supply Chain?
Ensure is a tough word, but there are certain steps that can be taken to make the supply chain more effective.
The first step here should be to lay out the supply chain requirements, roles and responsibilities at each stage of the clinical process with the clinical research group. If a CRO is being used, part of the value gained should be their experience with managing the supply chain particularly for Phase III multicenter trials (i.e., they should bring some best practices themselves and potentially some tools) and the contracting company must agree on roles and responsibilities for this phase.
Secondly, a common respository for information (both actual and planned) should be created so that all parties involved in the testing can provide updated plans and status throughout the clinical trials. This should be closely linked to the recording of patient data and import/export events as well as any ERP systems in use such that transactions need be entered only. This will also require systems outside of the enterprise to be linked in to provide specific information.
Third, planning for the entire clinical supply chain needs to be coordinated for a drug or molecule (across indications), preferably by a single person or group. This *could* be contracted out, provided that the third party has authority to shift production schedules if a supply chain issue is threatening to disrupt a trial.
Finally, all parties involved, including support parties and third parties, should be trained on the clinical trial process, what can go wrong, the costs involved if something goes wrong, and what criteria should be used to make decisions. The purpose of this is to break down the functional silos that can occur if a single group is trying to operate towards sub optimized KPIs (e.g., a manufacturing group trying to get a good OE but raising lot sizes and lead times to do this is limiting their ability to respond to unexpected events).