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Clinical trials today are crossing borders like never before, opening doors to groundbreaking treatments and life-saving innovations. For patients, it means access to therapies they couldn’t get at home. For sponsors and CROs, it’s a chance to reach diverse populations and accelerate recruitment.
But cross-border enrollment isn’t without its challenges. Every country has its own rules, regulations, and logistical hurdles. Moving people, coordinating care, and ensuring patients feel supported in a new place requires expertise and precision.
At Scout, we thrive in this space. Our team is dedicated to making cross-border enrollment seamless, efficient, and patient-centered. This blog dives into how we tackle the complexities, so trials succeed and patients get the care they deserve.
The Benefits of Cross-Border Enrollment
Cross-border enrollment changes the game for clinical trials. It opens a world of possibilities—quite literally. By reaching beyond borders, we’re not just expanding participation. We’re creating a faster, more innovative path to crucial treatments.
It’s a win for everyone involved.
Benefits for Sponsors
When sponsors look outside their home regions, the possibilities grow exponentially. The most obvious benefit is access to diverse patient populations. These are the people who make trial results more universal and meet growing regulatory expectations for representation.
Cross-border recruitment can also move much faster, especially in regions where medical needs are underserved. Faster enrollment means fewer delays, which can make or break a timeline.
Benefits for CROs
For CROs, cross-border enrollment is about offering sponsors more value, not just more patients. Running international trials strengthens global expertise and relationships, building a competitive advantage. Hard-to-reach populations and complex regulatory demands become strengths rather than challenges.
Benefits for Sites
Sites benefit from increased enrollment rates and exposure to global trials. This can elevate their reputation, attract future studies, and bring in funding to support infrastructure and staff growth.
Benefits for Patients
The patient story is the most inspiring part of this work. Cross-border enrollment means access—access to treatments they’d never have otherwise. For many, these therapies offer life-changing options that local healthcare systems can’t provide. Clinical trials often mean excellent care at no cost, and patients know their participation could help change medicine for others around the world.
When countries come together, everyone benefits. This is what drives me and the amazing team I get to work with every day.
4 Major Cross-Border Clinical Trial Enrollment Challenges
Cross-border enrollment comes with its share of hurdles. Sponsors, CROs, sites, and patients all face unique challenges that can derail timelines if not managed well.
Here’s where the biggest obstacles lie:
1. Regulatory and Legal Complexity
Every country has its own rulebook for clinical trials, and these rules can change unexpectedly. From visa requirements to data privacy laws like GDPR, navigating these complexities requires constant vigilance. Brexit has added another layer of difficulty, with stricter limits on data accessibility and compliance.
2. Logistical and Operational Barriers
Coordinating trials across borders is like solving a giant puzzle. Investigational products must move seamlessly across countries, while meeting storage and customs requirements. Language barriers, cultural nuances, and time-zone differences add further layers of complexity.
3. Patient-Centered Challenges
For patients, the decision to participate in a cross-border trial can feel overwhelming. Many are unaware of the opportunity, while others hesitate due to travel concerns or trust issues. Financial and logistical burdens, like arranging travel and accommodation, can also deter participation.
4. Financial and Technological Constraints
Cross-border trials come with added costs, from compliance to patient support services. Consistent technology use across sites is another challenge, as some locations lack the infrastructure for advanced tools like electronic data capture.
These challenges demand expertise, creativity, and a patient-first approach—qualities that Scout brings to every trial.
Scout’s Patient-Centric Solutions
At Scout, we don’t just solve problems—we create solutions that are personal, practical, and patient-focused. Every trial is unique, and so is our approach.
Here’s how we make cross-border enrollment work:
Visa Coordination
We are here to support patients, providing visa guidance based on their individual needs. Assessing their passport status, citizenship, the destination country, length of stay and travel frequency. Whether it’s a short-term tourist visa or a long-term relocation, we provide support so patients and families can focus on treatment, not paperwork.
Housing and Relocation Support
Relocating for a trial can be daunting, but we make it easier. From finding the right accommodation to arranging transportation, we tailor our support to each family’s needs. Whether it’s a pet-friendly apartment or wheelchair-accessible housing, we’ve got it covered.
Interpretation Services
Clear communication is essential. We provide interpreters for study visits and cultural liaisons to help families adjust to their new surroundings. From navigating hospital systems to finding local amenities, we ensure patients feel supported every step of the way.
Navigating Complex Scenarios
Every situation is different, and we excel at finding creative solutions. Whether it’s managing mixed citizenships or leveraging regional policies, we simplify the process so patients can focus on their health.
Adaptation to Regional Changes
The regulatory landscape is always shifting, but we stay ahead of the curve. From Brexit to upcoming electronic travel authorizations, we proactively adjust to ensure seamless operations for patients and sponsors alike.
At Scout, we believe cross-border enrollment should be as smooth as possible. By meeting challenges head-on, we make the process better for everyone involved.
Scout’s Cross-Border Success Stories
Our work at Scout comes to life in the stories of the patients and families we’ve supported. These moments reflect the dedication and care we bring to every project.
#1: Long-Term Relocation
One of the most rewarding projects we’ve worked on involved relocating a family to Belgium for a multi-year trial. We assisted the parents and the pediatric patient—and even ensured their dogs stayed with the family also!
Throughout their stay, regulations changed, requiring new documentation to keep their participation uninterrupted. Our team jumped into action, navigating the shifting policies with precision to ensure the family could stay where they needed to be. It was about more than logistics; we were able to help keep a family together and focused on their child’s treatment.
#2: Weekly Travel Assistance
Another memorable success involved a Croatian patient who traveled to Italy every single week for treatment. Weekly travel alone is a huge commitment, but add in language barriers, and it could have been overwhelming. That’s where our interpreter services made a difference.
For every visit, our interpreter was there, making communication seamless and ensuring the patient always felt supported. It’s details like this that turn a challenging trial experience into one that patients and their families can handle with confidence.
#3: Medical Coordination for Rare Diseases
One case that stays with me involves a young patient with a rare disease who needed to travel across borders for treatment—year after year. Their health condition made air travel more challenging than usual.
For five years, we coordinated everything from their flights to the safe transport of their medical equipment, ensuring it was handled with care. Nothing was left to chance. In managing these details, we gave the family peace of mind and helped maintain the child’s health and well-being throughout the trial.
The Scout Advantage
Our team is dedicated to simplifying the clinical trial process with a focus on what truly matters—patients. We’re a trusted partner in navigating the intricacies of cross-border enrollment with expertise and care. From regulatory hurdles to personalized support, we bring adaptability and creative problem-solving to every trial.
If you’re a sponsor, CRO, or site looking for a partner who understands the unique demands of cross-border enrollment, we’re here to help. Reach out, and we can find patient-focused solutions for trials that meet your goals and improve lives worldwide.
Cross-border trials remind us of the power of global collaboration. They bring us closer to life-changing treatments for people everywhere. At Scout, we’re proud to make this possible with every trial, visit, patient, and interaction.
Amy Franco joined Scout (then, Meeting Protocol Worldwide) in 2002 as a Senior Program Manager. Since 2020, she has served the Scout Clinical division in multiple capacities: Project Manager, Director of Project Management, and today Senior Director of Patient Liaisons. Click here to connect with Amy on LinkedIn.