With the often complex and bespoke nature of clinical trials, shorter shelf lives, more expensive study drugs and the increasing adoption of more patient-centric, decentralised approaches, efficient clinical supply chain management is critical. The use of technology can help remove some of the uncertainty. A risk-based optimisation of clinical trial supplies allows for proactive risk management and can significantly reduce trial supply costs and minimise drug waste.
More than 25% of all clinical supplies that are packaged and labelled are never used, even with expense forecasting and implementing lean. In fact, in reality, for most companies, it is closer to 50%. And as trial complexity grows, wastage grows too, mainly due to the introduction of safety buffers throughout the supply chain to account for uncertainty.
The flexibility offered by On-Demand Packaging & Labelling eliminates this waste and significantly reduces trial costs. Clinical trials with expensive and limited supply medicines, in particular, can greatly benefit from packaging and labelling as needed. Using software to optimise the supply strategy provides an accurate method for driving waste reduction and cost savings. Better time and cost-efficiency can then be achieved by Packaging & Labelling just in time, Direct-to-Patient shipping, optimisation of kit design, accelerated lead times and using the global network of a clinical trial service provider.
With an accurate picture of a global clinical trial supplies project and its integrated parts thanks to risk-based optimisation, one can make informed decisions regarding drug allocation and thus reduce inefficiencies at every step of the way.
Risk-based optimisation for clinical trial supplies management takes the guesswork out of determining the required amount of clinical trial material overage. It quantifies the risk in any given supply method for the specific trial protocol and evaluates the likelihood of the right medication to be on-site and on-time to be given to the patient.
An optimisation process captures all details of the clinical trial protocol and clinical assumptions to accurately model and simulate the trial. For a reliable risk management solution, thousands of simulations are carried out automatically to capture all potential scenarios. The results can then clearly indicate which supplies management strategy would best fit a given trial, and provide the minimum and maximum thresholds that the strategy will support without risk. Lastly, when the trial is on-going, it enables easy monitoring of the supply forecast and compares data with study actuals daily to alert the trial manager to re-run simulations based on real-time data and adapt the supply strategy accordingly.
On a practical level, an optimisation strategy allows for both reactive and proactive risk management. Reactive risk management is most suited for clinical trials at risk of drug shortage and treatment continuity for patients. Here, optimisation can help ensure trial continuity and avoid delays by finding solutions to mitigate risks while avoiding recruitment holds. Proactive risk management is therefore recommended for any trial in order to avoid these kinds of issues. It is especially important for complex trials, e.g. weight-based dispensing, lack of visibility on demand for clinical trial material, or smaller Biotech companies managing their first Phase III study. For all trials using simulations and optimisation, risk management will facilitate the daily management of the study, advise on ideal drug overage to use, and allow application monitoring and quick reaction in case of outliers.
Program-level optimisation takes into account the IMP demand from each individual trial in the program and all of the programme’s specificities and constraints in order to create the optimal clinical manufacturing plan. This ensures efficient allocation of resources and drug to trials while avoiding bottlenecks.
For programmes with a limited quantity of available drug, the result of supply chain management optimisation can be to find a solution for making the trial feasible in the first place, by making the trial as supply-friendly as possible while keeping a patient-centric approach. Optimisation typically reduces trial drug needs by 20-60%.
But for trial sponsors with the primary goal to accelerate time to market (e.g. for smaller Biotech companies or competitive indications), freeing this amount of medication can mean a potential increase in the number of clinical sites participating in the trial to accelerate recruitment, initiating new trials on other indications or accelerating the study start.
In sum, programme optimisation allows a clinical trial to evolve with the required flexibility and right drug allocation at the right time while enabling accelerated timelines.
Clinigen Clinical Supplies Management is partnering with N-SIDE , an innovative software consulting company, to further optimise clinical solutions provided to pharma and biotech companies.
N-SIDE’s proprietary software suite, leveraging advanced optimisation algorithms and forecasting techniques coupled with cutting-edge analytics, drives greater efficiencies for Clinigen clients. These include waste reduction, risk management, and drug allocation optimisation, allowing for better cost control, earlier patient access to clinical trials and a potential reduction of time-to-market.
By optimising a trial design, N-SIDE’s solutions provide exact supply chain requirements at the onset a well as throughout the duration of a study. Clinigen then delivers a tailored approach to each client and each project by implementing these requirements and any changes in the process to make optimisation a reality. By devising a strategy that meets the needs of a trial with built-in flexibility to handle faster timelines, Clinigen can help develop and adapt a supplies strategy for the length of a trial.
Contact us to discuss your clinical supplies needs and discover the benefits that an optimised supplies strategy could bring to your project!
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.