The increased demand and the complexities involved in the clinical trials have made the optimising practices of temperature-controlled supply chain methods to change according to circumstances. Improvements made in clinical supply chain methods becomes imperative as it enables you to create strategies and practices for efficient delivery of goods to support the needs of the clinical trials. Certain steps can be taken into consideration to make the improvement process easy yet effective.

  • Planning Ahead

Having an early plan to maintain a temperature-controlled supply chain process can help support all the systems involved within the manufacturing and site levels. A properly developed plan helps monitor supplies and align manufacturing, packaging and shipment aspects of the trial. It also enables you to forecast where the supplies will be, when they will arrive and when they will be used.

Temperature-controlled supply chain is often taken as the final stage of the drug manufacturing process required for clinical trials. During the process, upstream delays tend to occur that results in a chain effect on multiple levels causing more delays. Communication, effective planning and determining timelines helps to avoid delays. Often, delays happen that takes away all the timeline designed, so in such cases, it becomes imperative for the temperature-controlled supply chain process to remain within tight timelines and schedules to ensure effective manufacturing and delivery of goods. Gather as much information as possible about the trials to make an effective timeline.

  • Identify the Regulations

Knowing the location where the products need to be shipped is essential as there are different regulations for different countries. The time it needs to obtain approvals and permits for a shipment application varies from country to country. Hence, it becomes important to understand the regulatory requirements of each country before making a plan. Furthermore, some countries have lengthy import rules, so it is also important to keep these regulations into consideration while making your timeline schedules.

Depending on the country, you may face regulatory rules and import laws that can produce hurdles for you, so it is a great practice to research the regulations of that country before commencing the shipment. Take country-specific regulations in the notice before making plans for your temperature-controlled supply chain process.

  • Distribution to Sites

Direct distribution to the site during your temperature-controlled supply chain process can sometimes prove to be difficult, but proper planning can help you control this challenge. An effective way to ensure that the materials stay on course and delivered at the proper time and location is to use local depots in your clinical supply chain process. You attain such efficiency due to the removal of uncertainties regarding custom clearance and regulatory laws. As an added value, local depots help in controlling your overage cost as the materials remain in the depot until needed at the site, rather than remaining at the site without notice.

During your temperature-controlled supply chain process, shipping containers and methods should be carefully considered, analysed and utilised. You can prevent time-consuming investigations if you make sure that the product reaches without any damage or temperature issue. Supply chain partners can offer standard and customisable options to ensure that the drugs and materials reach the trial sites safely and on time while meeting quality standards.

  • Effective Strategy for Packaging

Another aspect of improving the temperature-controlled supply chain process for clinical trials is to prepare an effective packaging/labelling strategy. This will help you understand all the major and minor details within the process, like cost, stability, availability and dispensing. Learning about these factors enables you to make plans for any special packaging. Determining the label requirements is essential as the label text may vary from country to country. Try to make the label as much flexible as possible to remain compliant with all the countries. You can add text of all the countries in your product booklet so to cover all the country label requirements.

Additionally, labelling and packaging strategy also helps to determine the expiry date that can also vary from country to country. Sometimes, you may end up shipping a product to a country that has expiry label requirements. Hence effective labelling may end up saving you a lot of time and cost on different requirements as it becomes a standard for your shipment.

January 16, 2020
temperature-controlled supply chain

Steps to Improve the Clinical Supply Chain Process

The increased demand and the complexities involved in the clinical trials have made the optimising practices of temperature-controlled supply chain methods to change according to circumstances. […]