Today, we sit down with biopharma expert Ivan Kairatov to explore the high-stakes world of clinical trial supply chains. With deep experience in the industry’s technological and research frontiers, Ivan offers a unique perspective on the critical partnerships between sponsors, Contract Research Organizations (CROs), and their supply chain managers. We will delve into how proactive risk management can prevent catastrophic financial losses, the balance between cutting-edge automation and essential human expertise, and the strategies for building deeply integrated, trust-based relationships. The conversation will also touch upon navigating the inevitable challenges that arise during complex global trials and how a culture of care and specialized knowledge can transform a simple vendor transaction into a powerful, value-driven partnership.
Given that a single day’s delay in a clinical trial can cost sponsors over $600,000, what specific, proactive steps does a supply chain partner take to anticipate risks? Please share an example of how your team mitigated a potential delay and its financial impact.
That figure, over $600,000 a day, is exactly what keeps us on our toes. The financial impact is staggering, but the real cost is the delay in getting therapies to patients. Our approach is fundamentally proactive, not reactive. From day one, our dedicated project managers are trained to anticipate risks before they even have a chance to impact the timeline. They dig deep, pushing for the critical information they need to map out the entire supply journey. For instance, we recently had a trial with a temperature-sensitive drug product originating in one country and destined for multiple global sites. Our team immediately flagged a potential bottleneck at a specific customs checkpoint known for delays. Instead of waiting for the problem to happen, we leveraged our extensive global depot network to pre-position supplies in a regional hub beyond that checkpoint, effectively bypassing the risk. This single move prevented what could have easily been a week-long delay, saving the sponsor millions and ensuring patients received their medication on schedule.
CROs often grapple with compressed timelines and frequent protocol amendments. How do your project managers build adaptability into the supply chain from the start, and what kind of information do they prioritize gathering early on to prevent logistical breakdowns later in the trial?
Compressed timelines and protocol amendments are the reality of the CRO world; we see it as our job to absorb that pressure. Adaptability isn’t something you can bolt on later; it has to be woven into the very fabric of the plan. Our project managers start by building a comprehensive risk profile. They don’t just ask about the drug product; they ask about its entire lifecycle. They prioritize understanding the stability of the drug, the intricacies of the global regulatory landscape for that specific compound, and the capabilities of every site it’s going to. We push hard for clarity on patient recruitment forecasts and potential hurdles in each country. This allows us to build contingency plans from the outset. For example, if we know a protocol is likely to be amended to include a new patient cohort in a different country, we can proactively research import requirements and identify qualified couriers, so when the change comes, we aren’t starting from scratch. It’s this foresight that prevents those logistical breakdowns that can stall a trial.
You’ve highlighted the use of automation for speed alongside human expertise for adaptability. Could you describe a scenario where technology flagged a potential issue, but a supply chain manager’s judgment call and personal relationships were essential to actually solving the problem?
This balance is absolutely crucial because technology gives you data, but it can’t give you wisdom. I recall a situation where our automated tracking system flagged a critical shipment as “stalled” in a European airport hub during a snowstorm. The dashboard was a sea of red alerts, predicting a 48-hour delay that would have caused several patients to miss their dose. While the system provided the initial warning, it couldn’t solve the problem. Our supply chain manager, however, had a long-standing relationship with the regional manager of our preferred courier service. She got on the phone—not an email, a direct call—and leveraged that personal connection. Together, they found a creative solution: a different airline with a single cleared runway was flying to a city 100 miles away. They arranged for a dedicated vehicle to meet that flight and drive the shipment through the night to the clinical site. The technology told us what was wrong, but it was a person’s judgment, creativity, and trusted relationship that ultimately got the medicine to the patient on time.
Moving beyond a simple vendor relationship requires deep integration. How do you embed your teams within a CRO’s structure to foster open communication, and what does your relationship governance model look like on a day-to-day basis to ensure everyone remains aligned?
The term “vendor” just doesn’t capture the depth of the partnerships we build. We work intentionally to erase the lines between our organizations. This starts by building relationships at every level, not just with a single contact. Our teams connect with the CRO’s vendor management, procurement, clinical operations, and supply teams. This creates a web of communication, so information flows freely instead of getting stuck in a silo. Our governance model reinforces this. We provide a single point of contact to simplify communication, making our team feel like a natural extension of the CRO’s own. We also utilize shared, customer-focused platforms that offer complete visibility across all regions, ensuring everyone is looking at the same data. On a day-to-day basis, this means constant, open, and honest communication. It’s a true partnership where we aren’t just executing orders; we are co-creating solutions.
When a supply chain issue inevitably occurs, how do you manage the resolution and communication process to strengthen trust? Could you walk me through the steps your team takes after a problem is solved to conduct a post-mortem and implement lessons learned for the future?
In clinical trials, it’s not a matter of if something will go wrong, but when. How you handle those moments is what truly defines the partnership. Our first step is immediate, transparent action. But the real trust-building happens after the immediate crisis is resolved. We always initiate an open and honest conversation—a collaborative post-mortem—with our CRO partner. We don’t point fingers; we lay out the facts of what went wrong, what we did to fix it, and, most importantly, what we can collectively learn from it. We analyze the root cause and then co-develop new processes or checks to prevent it from happening again. People may not remember the specifics of the challenge a year later, but they absolutely remember how we handled it. They remember that we took ownership, that we communicated clearly, and that we turned a problem into an opportunity to strengthen the entire process. That’s how a transactional relationship becomes a deeply trusted partnership.
Having dedicated leads who understand CRO culture is a unique approach. What specific challenges or priorities do CROs have that differ from other pharma clients, and how does this specialized expertise translate into more efficient and value-driven outcomes for them and their sponsors?
This is a key differentiator for us. A CRO is a fascinating and unique type of client. They serve as a barometer for the entire pharma industry, often bearing the brunt of geopolitical shifts, funding constraints, and intense sponsor scrutiny. Their priorities are unique; they operate under immense pressure to deliver on time and on budget, as their reputation and future business depend on it. Unlike a sponsor who is focused on a single drug portfolio, a CRO juggles multiple programs for various clients, each with its own set of expectations. Our dedicated CRO Operational Leads have lived and breathed this culture. They understand that pass-through costs are being meticulously scrutinized and that sponsors demand clear evidence of value. This specialized knowledge allows them to anticipate CRO needs, speak their language, and proactively manage the supply chain in a way that aligns with their business model. This translates directly into more efficient trials, fewer budget overruns, and ultimately, greater confidence from the sponsor.
What is your forecast for the evolution of clinical trial supply chain partnerships over the next five years?
Looking ahead, I believe the line between supply chain partner and CRO will continue to blur. The model will shift from a fee-for-service transaction to a fully integrated, risk-sharing partnership. We’ll see technology, particularly AI and predictive analytics, become even more embedded, allowing us to move from proactive risk management to predictive risk elimination. This will require an unprecedented level of data transparency and trust between partners. Furthermore, as trials become even more decentralized and patient-centric, the supply chain will become the central nervous system of study delivery, managing direct-to-patient shipments with absolute precision. The successful partners of the future won’t just be logistics experts; they will be data scientists, regulatory strategists, and relationship architects, all working in seamless concert with their CRO and sponsor counterparts to bring new therapies to the world faster and more efficiently.
