Getting serious about reducing clinical trial costs means changing your mindset and adopting new processes that will put power back into your hands. We know that studies are costly and becoming increasingly complex.
Those complexities drive up the cost of traditional clinical supply chain services that depend on forecasts, which often fail to respond efficiently to unplanned study changes. However, innovative approaches to clinical supply chain management can help keep your study’s costs low and predictable.
A clinical trial's timeline not only plays an important role in the overall cost and budget, but it also can significantly help or hinder the launch of a new drug. With traditional packaging and labelling, a typical lead time is eight weeks or longer. This places packaging and labelling on a critical path requiring project managers to monitor the process closely and incorporate necessary changes. At times, managers have to accept emergency processing fees to ensure supplies are delivered on time.
Applying methods that allow you to package and label clinical supplies only as needed completely changes the timeline strategy and related costs. It can also significantly shorten the period between protocol approval and first-patient-in.
Our On-Demand processes allow trials to be up and running in just a few weeks even with unforeseen changes because the packaging and labelling take only hours to complete. As a result, clinical supplies are taken off the critical path, and project managers can focus on other problem areas — such as studies not using On-Demand methodologies.
Unexpected changes are inherent to clinical research and will inevitably affect your study's budget. These changes could include ending the trial early, slow enrolment, prescription drugs expiring, or adding new countries.
When traditional packaging and labelling methods are used, any of these changes can result in medication that has already been paid for sitting in inventory. Changes generally involve not only additional costs but, more importantly, lost time.
Consider adopting a clinical supply chain and distribution model that allows you to supply medication only as needed. Such a model for resource planning allows changes without incurring additional costs or committing your entire drug supply upfront. Using a flexible supply model will nearly eliminate both rework and unplanned expenses due to drug waste.
You shouldn’t be willing to spend money on kits that may never be used, especially if a trial is delayed or ends unexpectedly. Packaging and labelling costs should only be charged when the medication is shipped to the clinical site.
Contracting clinical supply services typically occur four to six months before you actually need the supplies. The problem with planning and signing a contract months before a study starts? Things will change, leading to changes in the original contract and making the original bid process meaningless.
The only way to ensure an accurate contract is to finalize the bidding supply chain processes a few weeks before the trial starts. At that time, more information is known and fewer changes will occur.
The burden of packaging and labelling only what is needed resides with the vendor and should not be passed on as a cost of doing business because of the vendor’s poor supply chain management. Work with companies that can engage your study's needs weeks (not months) before the start of your trial.
Let's face it, managing trials will not get simpler, and it's likely that cost estimations will continue to climb. Mitigating these trends by introducing some or all of the methods outlined is something you can do on your own or with the help of a provider of clinical trial management services.
Adopting new processes can be daunting, but working together with one global partner and one point of contact can easily help eliminate unnecessary elements of complexity from a clinical trial and reduce costs as a result. Clinigen Clinical Supplies Management offers just that: global end-to-end clinical trial services. Thanks to local presence, a truly global experience, and a personalized approach, we can help streamline your clinical trial no matter how complex it may be.
How can we we help? Speak to a Clinical Supplies Management expert and learn how we can support your study.
As a leading provider on a global scale, Clinigen is committed to delivering fully integrated logistics services to our clients. Over 80% of the studies we are supporting are multi-national and we organise shipments to 110+ countries.