Clinical trials in the UK and international market is essential for procure access to the larger pool of potential participants for different studies and ensure medicines can be approved in multiple regions. However, the management of global clinical trial logistics also has its share of challenges in different regions. For instance, the regulations in some emerging markets may not be as clear as they are in the UK as it has been fluctuating in recent years. In such emerging markets, the timelines for submission and approvals of trials can vary depending on the regulations. Import and export rules also produce inconsistency and make it more difficult for planning and coordination of clinical products.
Before jumping into the prospect for clinical trial logistics, first, you need to identify what the key challenges are. Only then you will be able to overcome them for a successful clinical logistics. Let us discuss some major challenges that clinical trials in the UK face:
Time-restricted shipments and limitations are always an issue in clinical trial logistics, and many of these issues can be properly handled by having a clear and strategic communication channel. Communication is the key aspect of any logistics, and it holds the same importance in the procurement of clinical trials in the UK. Communication should be open between teams and team members to address and document any issue as soon as it arises and ensuring that the information is accurate and updated. Effective communication during the planning and scheduling process makes deadlines achievable and realistic. Whenever issues arise, it is important to communicate and address the solution without disrupting the flow of the supply chain and to keep sponsor costs low. If the issues and errors are not communicated properly, a coordinator needs to backtrack through the supply chain to determine where things went wrong.
For the coordinators involved in the global clinical trial logistics to carry out their job successfully, they need to be a part of an unbiased staff and receive proper education and training to understand the unbiased process. Unfortunately, there have been numerous coordinators involved in the practice of inappropriate biases with the intention of limiting their knowledge of clinical trials and their details. This would also include no knowing which codes have been assigned for which treatment within the study.
The main purpose of keeping the coordinators blinded and not given proper information is to eliminate biases in the process. For instance, if the staff comes to know that some patients are receiving placebo in comparison to others that are receiving active drugs, the treatment process may change considerably and produce negative effects on studies of clinical trials in the UK. To eliminate such an activity, you need to have someone on your team who is not blinded and has a clear understanding of the reaction and their sources in the patients. Un-blinded and unbiased staff members are able to investigate the effects of any drug given to a patient and document any adverse reactions it causes.
Another key issue in clinical trial logistics is the lack of proper on-site training to staff for receiving or returns (in case of damages) and maintaining the temperatures where needed. Whenever products go off-site, other involved within the chain might not be as careful as you are. To aid the products of clinical trials in the UK, proper knowledge and training is required for safe handling or the return shipment. Proper site training is essential to handle receiving and returning on both onsite and off-site location to ensure a smooth transition of products with as much less hassle as possible.
Things start to fall apart during a change in any leadership, and if the site or inventory managers who handle all the inventory are replaced, it has its effects too. It takes time and effort by the newcomers to take charge and understand the process of clinical trial logistics in practice. Communication is again a key player in this aspect as the new leadership demands updated records which have been maintained by the teams. It takes time to locate the person within the process in clinical trials in the UK, so be sure to maintain any or all of the information about the sites before handing them to the new person.
Even if the old management is taking charge again, be proactive in making an updated record of numbers rendered to clinical trial logistics ensures timely identification of concerned coordinators as well as take the lead on track.
Challenges are a necessary part of any supply chain process, and clinical trials in the UK are no exception. However, addressing these issues on time and mitigating the effects it creates is of utmost importance. Communication is the key part where the teams coordinate to address the issues as soon as they start to rise rather than lingering it on to a later date.