When dealing with global clinical trial logistics, the only thing you can be sure of is a challenge. You may have a smooth day today, but it’s a guarantee that you will face a new challenge tomorrow. You must be ready to address it, understand the risk, and apply solutions.
Challenges come from everywhere, and it seems they affect everything. For this post, I’ve selected some of the most common challenges we deal with on a regular basis and share strategies to overcome the challenges.
1. Local IRB/EC requirements vary by country (plus they are constantly changing)
The timelines for submitting and receiving IRB/EC approvals to conduct a trial can vary widely. That’s why it’s important to plan ahead and get a list of all participating countries (and potential countries that could be included). This will enable you to build strategic timelines for submissions and approvals and be prepared as more countries come on board.
This list of participating and expected countries is also a critical tool for planning transportation-related logistics.
2. Inconsistent import and export regulations for transporting clinical products and equipment
Knowing importation rules and keeping up to date for each country is key with global clinical trial logistics to keeping a project on time. Make sure you are consistently engaging local authorities to stay up to speed in this volatile environment.
Specifically, determine the latest import/export licenses and regulation documents required for each country so you’re ready to comply with these throughout the trial. Examples of questions to ask include:
- Can we export needles to that country?
- What about alcohol swabs?
- Is this product considered a medical device?
Imperial’s export compliance manager, Dan Polkowski, states, “Proactive global logistics planning in advance of shipping takes time, and this approach may seem like extra work. However, it is a much better option than having your trial supplies held by country import customs for days, weeks, and possibly months.”
3. Finding patients, many times in remote areas
We can now recruit patients in exceedingly remote areas thanks to advances in virtual and hybrid clinical trials. This introduces special global clinical study logistics challenges, including product delivery to remote locations and longer distances required for patients to travel.
Additional challenges are the technical ones: Is there reliable internet service to keep sites and patients engaged? Can we get the study drug to the patient’s home in a timely manner and keep it within the required temperature range? Does the patient have suitable storage capabilities? Are we following direct-to-patient guidelines?
Plan ahead, make sure you know the answers to these questions, and can handle these challenges.
4. Procuring and placing ancillary supplies & medical equipment
Our industry has experienced a limited supply of ancillary supplies, equipment, and comparator drugs in the last few years. We do not expect things to improve in the short term.
With more trials being conducted globally every day, it’s crucial to have a strategic approach to the procurement of ancillary supplies and medical equipment.
It’s not about finding the easiest approach but the best approach. This includes examining:
- Source global and ship vs. sourcing locally
- Best price vs. longer expiration date
- Brand name vs. generic
Imperial’s vice president Allison Schmoekel suggests:
Diversifying your supplier base can also help reduce inventory shortages by creating a wider network of suppliers to provide goods and services. It is important to have a robust vendor qualification process to ensure new vendors are reputable, product quality is satisfactory, and inventory levels are adequate. Due diligence with all key suppliers is vital to ensure suppliers will meet the appropriate quality and safety standards and supply needs.
The more agility your organization has to:
- make purchasing decisions quickly
- spot-buy strategic inventory as it becomes available
- approve new vendors
- select acceptable product substitutions
- build as much product and equipment flexibility into the clinical trial protocol as possible
…the easier it will be to navigate many clinical trial supply chain challenges.”
Key strategies for overcoming any global clinical trial logistics challenge include:
- Leverage existing technologies and integrate them when possible
- Adopt a flexible supply chain design model
- Incorporate redundancy in the plan as a contingency; never assume that everything will go as planned
- Engage with regulatory agencies, local and international
- Plan in advance… don’t wait, anticipate
- Encourage open communication
- Expect the unexpected
I’ve touched on only a few global clinical trial logistics issues here. Think about all the obstacles that could delay your study timeline, including cultural differences, language barriers, diverse transportation and delivery times, the need for emergency technical support, and an erratic business condition in each country.
You don’t have to go it alone! Imperial is in the logistics business, contact us and we can step in to help.