The pressures placed on your pharmaceutical supply chain continues to evolve and intensify and the importance of effectively managing the logistics is even more critical to your clinical trial’s success. Without a smooth-running, process-driven, compliant and adaptable supply chain, the quality, delivery, safety and potentially overall effectiveness of your drug can be compromised.
But, how do you find the right partner who will serve as your trusted link between the lab and the patient? Do your research and establish a deep and open relationship with an organization who can provide expertise throughout the process — from packaging to temperature management to storage and distribution — while at the same time focusing on speed, efficiency and cost-effectiveness.
But, where do you start? You can begin by asking the following questions to evaluate the supply chain partner who will best suit your needs.
Market forces are constantly challenging your supply chains. From regulatory changes to complex drug and customer needs, your partner must understand and pay attention to the constantly changing market and how it affects your entire supply chain. What works today, may not be effective or efficient tomorrow. Your partner should be able to react quickly to trial needs, changing volumes or regulatory updates and be willing to adjust and implement corrective actions when things don’t go according to plan.
In addition, not every organization has the ability to scale with you and invest in new equipment, storage capabilities or customized shipping, for example. A true partner is willing and able to make these adjustments and invest in your company’s future.
Bellwyck is specifically structured to adapt to changing clinical study needs. In fact, you might say we thrive on it. We never back down from a challenge. Whether it’s a customer who has a unique equipment request or one with advanced storage needs, we always look for ways to accommodate and find the solution for every request and requirement that comes to us.
Often, small and midsize drug companies don’t receive the close, intimate, and detail-oriented attention they deserve from larger supply chain partners. This can mean two things — either they won’t get to know your unique drug and study needs and/or they won’t be able to scale with you because the larger teams are focused on much bigger clients. Again, these companies mostly serve as your vendor, not your partner.
Regardless of company size and dollars spent, supply chain partners should provide the same high-quality service to every client. This is our approach at Bellwyck. We want to be a true extension of your team — regardless of the size of your clinical trial. It’s the only way to truly understand your needs and help you think about and prepare for changes to your studies. We have set up our business to accommodate yours — well into the future as you grow and evolve.
When evaluating partners, especially when highly sensitive drugs are involved, many drug companies send QA auditors to the sites of potential partners for hands-on experiences with the site and to vet their processes. From there, you can evaluate and choose which organization’s assets and capabilities best fit your needs. Your supply chain partner should be more than willing to go through this process with you and make adjustments to its facilities or process controls in order to ensure they are compliant with your needs.
Bellwyck welcomes outside auditors to walk through and evaluate its facilities and procedures. In fact, we open our doors to 30+ clients every year for auditing. In addition, the FDA and Health Canada perform specific regulatory audits on a consistent basis. We value this feedback which gives us an in-depth overview of your needs. In fact, we consider any costs necessary to update or revise processes and facilities as the cost of doing business in order to get your drug delivered safely and within the industry’s regulations.
Your partner should be proactive in understanding your packaging and labeling needs to protect your patient and the integrity of your product. If they are not focused on the cost of the drug, how it will be administered, how complex the dosing is, etc. you’ll often waste valuable time and money making it right after discoveries are made well into the process.
At Bellwyck, we often have frustrated clients coming to us to fix their labeling and packaging designs simply because their partner did not do their due diligence and recommend the right strategies from the beginning. There is rarely one packaging and labeling strategy that works in every situation which is why we work very closely with our client’s teams to dive deep and examine your specific trial variables.
Ask your partner for success metrics. They should be willing to share customer satisfaction, on-time delivery and temperature control metrics with you. In addition, ask if there is a validation protocol in-house or if an outside service is used. Bellwyck is open and honest about our metrics of success and having an in-house compliance team allows us to turn around the process much faster.
As clinical trials continue to increase in complexity, extensively evaluating your supply chain partner is even more critical today. From beginning to end, having the right people, facilities, equipment, processes and procedures in place will allow you to get your drug into the hands of your patients quickly, safely and cost-efficiently.
Bellwyck Pharma Services