Expert perspective: Navigating regulatory challenges in ancillary supply management
“Ancillary supplies encompass everything but the drug, yet they can delay a trial just as quickly as an IMP issue”
In this expert perspective blog post, we have two specialists from Thermo Fisher Scientific, Caitlin Smalley and Molly Isermann.
Caitlin Smalley is a Regulatory Affairs Specialist and has been with Thermo Fisher’s Clinical Ancillary Management (CAM) team for six years. Caitlin holds a master's degree in biotechnology with a specialization in regulatory affairs. Caitlin also holds a certificate in medical device regulations from the University of San Diego. She has been a member of the Regulatory Affairs Professional Society since 2019.
Molly Isermann is a Senior Manager of Product Management for Clinical Ancillary Management at Thermo Fisher Scientific. With over 20 years of industry experience, Molly has worked in various roles in quality control, analytical chemistry, business development, and customer support. For the past 15 years, she has specialized in providing laboratory and clinical trial solutions to Thermo Fisher customers. Molly is passionate about supporting the industry and collaborating with customers to find innovative solutions for global supply strategies.
Caitlin and Molly share the most common regulatory pitfalls customers experience across global studies, and the steps required to avoid them.
Q. What are the biggest regulatory hurdles customers face in ancillary supply management, particularly in global trials?
Smalley: The biggest hurdles are often volume of regulations and variability among regions. Each country views ancillary items through its own regulatory lens. There is limited harmonization and requirements are often changing. Without a structured review up front, companies are often surprised by country specific documentation or approval requirements.
“Global compliance isn’t just one checklist, but rather multiple country-specific playbooks.”
Isermann: Operational details compound the challenge. You need vendors that are approved and audited, documented distribution pathways for each region, and contingency plans (e.g., tariff changes or disasters) that ripple through supply chains. Customers often underestimate how much coordination it takes to keep global sites compliant and on time.
Q. What regulations or scenarios most often catch customers by surprise?
Smalley: Device status and market access. Some countries require the device you plan to use in a trial to be approved in that country. Teams may validate a specific adapter or setup during feasibility only to discover it lacks the required marking or registration in half their target markets. The fix is early regulatory review and, when needed, recommending globally acceptable alternatives.
Isermann: The closeout process. Trials must close the books on equipment used under a specific protocol. Depending on the market, there are restrictions on transfers, disclosure/traceability expectations, and service records to maintain. Disposition (return, recycle, or destroy) sounds simple, but it’s paperwork‑heavy and time‑consuming without a plan.
Q. How does Thermo Fisher Scientific mitigate these risks before they become delays?
Smalley: We engage at the request for proposal (RFP) stage, before quotes are even drafted. We classify the products, confirm country‑level admissibility, and list the documents needed for depot and site receipt. That early pass prevents unshippable items from making it into the plan.
Isermann: In parallel, our solutions team checks inventory and lead times, and maps the distribution path by region. For example, if there’s risk like a device isn’t accepted in a subset of countries, we present compliant substitutes. Keeping supplier performance data (service levels, turnaround times, etc.) lets us hold vendors accountable and prioritize premium partners.
Q. What does Thermo Fisher’s supplier qualification look like, and what should customers look for in vendors?
Smalley: Thermo Fisher’s supplier qualification aligns with our current global and CAM standard operating procedures. An initial screening involves a detailed questionnaire, quality documentation review, risk assessments, and site audits. Thermo Fisher can then approve a supplier and begin contracting. Continuous monitoring and periodic re-evaluation of the supplier’s performance with business reviews is organized to ensure ongoing compliance, quality, and support.
When evaluating vendors, customers should consider several key factors to ensure they select reliable and high-quality partners:
- Quality and compliance
- Reputation and reliability
- Financial stability
- Product and service quality
- Supply chain management
- Customer service and support
- Cost and value
- Innovation and technology
- Sustainability and ethics
- Scalability and flexibility
All of these factors are reviewed by Thermo Fisher when contracting a supplier.
Q. What are some common regulatory missteps, and how can customers proactively avoid them?
“The biggest misstep is looping regulatory in too late… Engage early and allow time to pivot to a globally acceptable option.”
We had a client that vetted infusion adapters for their clinical trial based on preclinical studies conducted in the US. We later found out that the trial footprint would include the EU and several APAC countries. The original infusion adapters were not approved and did not have the appropriate compliance markings and could not be distributed to the full trial footprint. The original adapters were only triaged for the United States.
Isermann: I would say the second is under‑resourcing project management. If you compress timelines or attempt to self‑coordinate multi‑country sourcing and distribution without vetted paths, delays stack up. You have to plan early.
Q. How do evolving regulations and market conditions affect clinical studies?
Smalley: Customers should expect change. For example, there are new FDA guidance coming for medical devices that use AI-enabled software[1]. These types of devices will also be impacted by trade laws when shipping for clinical trials. Shifting trade rules, and changes in marking compliance standards can affect studies. Also in 2021, the UK rolled out the UKCA marking which replaced the CE mark post-Brexit. The UKCA marking proves compliance with UK regulations. In 2023 the UKCA mark became mandatory for medical devices and electronics, two common ancillaries[2].
Isermann: World events affect clinical studies, from natural disasters to tariffs. Having preapproved alternates, multiple distribution options, and a communication plan with sites prevents single‑point failures from becoming dosing delays.
Q. For customers running trials across multiple countries, what are the best practices for ensuring smooth regulatory approval and supply chain continuity?
Smalley: Transparency is key to smooth operation of clinical trials. Thermo Fisher’s Clinical Ancillary Management services is here to serve our clients and provide solutions, and we can be brought in earlier to ensure the trials are ran seamlessly, even with change orders and resupplies.
Conclusion
Ancillary supplies may not be prioritized as much as the investigational drug, but they carry equal weight in determining whether a clinical trial stays on track. Regulatory mistakes, incomplete supplier qualification, or failure to anticipate country-specific requirements can quickly create delays that ripple across clinical trials. As our experts highlight, the most effective way to avoid setbacks is to plan early, engage regulatory review before decisions are locked in, and build flexibility into every supply chain strategy. By prioritizing ancillary management, customers can minimize risk, adapt to evolving regulatory requirements, and ensure patients receive their treatments on schedule.
Discover how our tiered Clinical Ancillary Management Services can streamline your global trials. Read our fact sheet.
