Clinical trials are dynamic endeavors, filled with numerous intricate components that must work together seamlessly for success. One of the most complex aspects of this process is study supply and equipment planning, which encompasses the procurement, storage, warehousing, and global distribution of ancillary equipment and supplies. In fact, the efficiency of the supply chain plays a critical role in determining the operational success of each study site.
To begin, effective discovery and planning are the foundations of successful clinical trial execution. The earlier you start this process, the better your chances of ensuring smooth operations. When planning for the supplies and equipment needed in clinical trials, it is important to consider many factors, and thorough and accurate discovery is essential.
Choosing the right equipment and supplies may seem straightforward, but the stakes are extremely high. For instance, using infusion supplies that haven’t been tested for compatibility with a specific study drug can lead to problems. Similarly, a centrifuge that doesn’t meet the necessary specifications for lab sample processing or a refrigerator that fails to maintain required temperatures can jeopardize the integrity of your study. Invalid study outcomes and potential patient harm can result from these missteps.
In this blog, we explore the vital points necessary to effectively plan and execute a clinical trial that relies on essential supplies and equipment. We uncover what it takes to navigate this complex landscape and ensure successful trial outcomes.
Study Protocol
When conducting clinical trials, having a well-defined study protocol is essential. At a minimum, you’ll need a protocol synopsis, but it’s advisable to provide the full protocol to the vendor responsible for procuring your supplies. Think of the protocol as your blueprint or roadmap—it clarifies your project’s objectives and, most importantly, outlines the use case for your study supply and equipment planning.
Your vendor requires specific information, such as:
- What tests and procedures will the supplies and equipment facilitate?
- What occurs at each study visit, and what items will be required at those times?
- How many patients are being randomized into the study? This detail is crucial, as it not only impacts the scale of the study but also affects the quantity of supplies needed.
In some cases, protocols are very specific, detailing every piece of equipment required, including brand, model number, and specifications. This level of precision means you must supply all study sites with the same equipment. While some flexibility is possible with sponsor approval, straying from exact specifications may not be permitted, especially if compatibility testing has already taken place. Introducing alternative items without prior testing can introduce delays—something nobody wants in a clinical trial, as these can lead to increased costs and complications.
Assessments and Supply Requirements
An essential component of the protocol is the schedule of assessments, typically presented in a table format that breaks down the procedures occurring at each visit. This serves as the ultimate guide for required supplies and answers critical questions, including:
- Will blood tests be conducted?
- What about urine tests or oxygen level checks?
- Will pregnancy tests be included?
- Is weighing patients part of the process?
- How about measuring body mass index or taking temperatures?
- Are movement assessments, like walk tests, relevant?
Based on these considerations, you can identify the various supplies needed for your trial. For instance, at least 17 key items might include:
- Needles
- Syringes
- Tourniquets
- Blood tubes
- Shipping vials
- Bandages
- Alcohol/sanitizing wipes
- Urine cups
- Urine test strips
- Pregnancy tests
- Scale
- Handheld fat caliper
- Thermometer
- Measuring tape
- Cones
- Stopwatch
- Pulse oximeter
To support these decisions, a reliable vendor partner can assist you in analyzing the protocol to determine the equipment and ancillary supplies necessary for your trial’s execution. Depending on the site, some might provide their own supplies and charge you for usage, while others may expect you to furnish everything. Conversely, some sponsors prefer uniformity across all study sites by supplying identical items.
All of these considerations start with a solid protocol—your foundation for a successful clinical trial.
Study location
When engaged in study supply and equipment planning, one aspect that is often overlooked is the significance of the study location—specifically, the countries where the study sites will be situated. It’s not just a matter of convenience; the chosen locations can have a profound impact on the necessary clinical ancillary supplies and equipment. Therefore, selecting the right countries early in the planning process is critical, influencing many other elements as the study moves forward.
How study location impacts logistics and compliance
So, why is location so pivotal? The countries where your sites are located impact supply issues in the following four areas:
1. Customs and Regulatory Compliance
One of the most crucial factors to consider is customs and regulatory compliance. Different countries have various regulations concerning medical supplies and equipment, which can lead to challenges. Some items may even be prohibited, while others may only allow specific types or brands. Establishing a strong partnership with a reliable supplies vendor can help navigate this complex landscape. It’s essential to conduct thorough research to determine which items are permissible and available in your chosen countries to avoid the painful experience of dealing with customs issues.
2. Logistics Costs
In recent years, logistics have become increasingly complex due to global events like Brexit, the COVID-19 pandemic, and regional conflicts. These complexities have heightened the costs and challenges associated with shipping supplies and equipment to study sites. Factors such as the size, weight, and value of your shipments, as well as their origins, play a critical role in determining logistics costs. To mitigate these expenses, consider regional procurement centers and distribution plans that minimize transportation distances.
3. Suppliers
The geographic location of your study sites necessitates a diversified network of suppliers. Compliance and cost factors will necessitate collaboration with local manufacturers and distributors capable of delivering the necessary goods successfully. While this can simplify sourcing, sticking with large multinational companies with facilities across various regions is an option, but often, you’ll need to connect with entirely different suppliers who can meet your study specifications.
4. Study Timelines
In clinical trials, time is of the essence. Various timelines and acronyms—like SIV, FPI, FPLV, and LPLV—appear frequently in study planning discussions. Multiple factors can influence these timelines, including background research, vendor outreach, budget approvals, and lead times for supplies. Delays can occur due to backorders, manufacturing issues, and broader environmental factors such as trade wars or customs problems. It is essential to consider all potential challenges when developing your study timeline.
Choosing the right study location is crucial for the success of a clinical trial. Factors such as regulatory compliance, logistics costs, supplier networks, and project timelines all play a significant role in this decision-making process. The earlier you start planning and finalizing your locations, the better prepared you’ll be for a successful clinical trial.
Study Supply and Equipment Planning: Study Details and Scope: Discovery
As we covered above, there are many factors to consider during the study supply and equipment planning process. Here is a quick cheat sheet to help your teams get their ducks in a row before reaching out to your vendor for support.
1. Gather study documents
- Protocol
- Lab manual
- Pharmacy manual
2. Outline all high-level study facts
- Study name
- Protocol number
- Condition being studied
- Phase of the study
- Number of sites involved
- Locations of sites
- Number of patients
- Key dates
3. List of items your team has identified that sites will need
- Include all the specifications that need to be met for each item.
- Include any brands or model numbers that you have pre-qualified through compatibility testing or other needs.
- Are alternative items acceptable? Sometimes the item you’ve specified isn’t available when or where you want it. Let your vendor know if you have flexibility and are open to recommendations.
4. Logistics details
An example would be whether you can act as an importer of record (IOR) for in-country responsibility of the goods sent to a particular country, or if you need help from the vendor. (Our ebook Ancillary Supplies and Equipment for Clinical Trials: A Project Management Approach defines and describes the role of the importer of record.)
5. Storage and shipping requirements
Be sure to detail any specific requirements, such as temperature controls.
6. Customer-supplied goods
Indicate which items you will provide to the vendor, either directly from your facility or through your partners.
7. Kiting needs
Specify any items that need to be kitted together.
8. Equipment preferences
Clarify whether you want to purchase or rent the equipment, and if you opt for renting, indicate how long your sites will require it.
9. Budget considerations
Outline your budget for this project. Similar to automobiles, the market for ancillary supplies offers a range of choices, from basic models to those equipped with all the extras.
Final Reminder
Remember, those who fail to plan are planning to fail. While it may be a cliché, it’s certainly true. Start early, secure a reliable supplies and equipment vendor partner, and be prepared for changes. Change is just as inevitable in clinical trials as death and taxes are in life.
For more on this topic, download our ebook, “Ancillary Supplies and Equipment for Clinical Trials: Details, Decisions, and Making it All Work.” Download the ebook here.