In honor of International Clinical Trials Day – a day dedicated to celebrating the vital contributions of clinical research professionals and organizations around the world – we sat down with our CRO’s CEO, Aurélie Weiss-Guimet, a clinical research professional with nearly 20 years of experience. In this interview, Aurélie shares her insights on the evolving landscape of international clinical trials, what inspired her decision to expand our full-service CRO reach globally, and her hope regarding biotech innovations. Join us as we explore her expert perspective and celebrate the people who make progress in healthcare possible.

How do you envision the future of clinical trials, and what role will CROs play in shaping it?

The future of clinical trials will be shaped by a combination of scientific innovation, regulatory evolution, and increasing patient expectations. We are moving towards more decentralized, technology-enabled, and patient-centric models. These changes will accelerate timelines, broaden patient access, and enhance data quality through real-world evidence.

In this evolving landscape, CROs must do more than just execute tasks – they must serve as strategic partners capable of guiding biotech sponsors through growing complexity. This includes not only operational delivery, but also early input on trial design, regulatory pathways, and site engagement strategies across regions.

One key strategic choice for sponsors is the selection between a Functional Service Provider (FSP) model and a full-service CRO. The FSP model can offer flexibility for sponsors with strong internal capabilities who need to scale specific functions like monitoring or data management. However, it often creates a heavier coordination burden on the sponsor, particularly in complex, multi-country trials.

Conversely, a full-service CRO can bring greater cohesion, accountability, and integration across functions, which is particularly valuable when timelines are tight or when internal sponsor teams are lean. The advantage of working with a small, full-service CRO lies in its ability to combine operational breadth with agility.

At ExperTrials, we offer comprehensive services – from clinical operations and regulatory affairs to data management, biostatistics, and medical monitoring – while maintaining the responsiveness, senior oversight, and personalized attention that larger CROs often lack. Our status as a small CRO does not limit our reach – we successfully operate with a global reach across 24 countries, allowing us to support international trials with local expertise and seamless coordination.

Ultimately, the CROs that will shape the future of clinical research are those who can combine operational excellence with strategic insight – whether supporting a full-service engagement or a hybrid model. The key is not size, but the ability to deliver value, solve problems proactively, and align closely with each sponsor’s vision.

What motivated your CRO to expand internationally, and what benefits have you seen from conducting global clinical trials?

As a CRO founded in Europe and deeply embedded in the biotech ecosystem, our motivation to expand internationally came from two primary drivers: the needs of our clients and the realities of clinical development today.

Many of the biotech companies we support are developing innovative therapies for rare or aggressive diseases, often with accelerated pathways in mind. To meet regulatory expectations and enrollment goals, they need to run studies across multiple countries. Being able to offer global reach without the red tape or rigidity of large CROs became a clear competitive advantage.

We also saw that patient access, site performance, and regulatory timelines can vary widely depending on which region the trial takes place in. By establishing international operations, we can offer more strategic site selection, diversify recruitment pools, and mitigate risks like delayed enrollment or overreliance on a single region.

“This international expansion has reinforced our positioning as a full-service, agile CRO that can deliver both strategic insight and operational excellence for biotech companies operating on a global stage.” – Aurélie Weiss-Guimet, CEO and Founder of ExperTrials

The benefits have been significant. Conducting global trials has allowed us to:

➡️ Accelerate recruitment by tapping into high-performing sites across different continents.

➡️ Navigate diverse regulatory frameworks more effectively, thanks to local experts embedded in our model.

➡️ Build strong relationships with investigators and KOLs in key therapeutic areas across regions.

➡️ Support sponsors pursuing FDA, EMA, and other regional approvals with aligned clinical strategies.

➡️ Offer global operational reach without the rigidity and overhead of large CROs, ensuring flexibility, speed, and personal attention.

International biotechs are ExperTrials’ market niche. Want to know why?

What is your greatest hope regarding the impact of clinical trials on patients and global healthcare?

Our greatest hope is that clinical trials become faster, more inclusive, and more impactful, so that life-changing therapies reach the patients who need them without unnecessary delays.

Too often, innovative treatments are slowed down by fragmented systems, rigid processes, or the inflexibility of large CROs whose structures are not always aligned with the pace or needs of biotech development. We believe clinical trials should not be a bottleneck in innovation, but a bridge that connects science to real-world benefit.

We want to see a future where:

➡️ Patients have access to clinical trials as a genuine care option, regardless of geography or socioeconomic status – not just in major urban centers or academic hospitals.

➡️ Trial designs reflect real patient needs, incorporating quality of life outcomes and diversity from the start.

➡️ Regulators, sponsors, and CROs collaborate more proactively to de-risk development and accelerate access to effective treatments.

➡️ Biotech innovations in rare and aggressive diseases are supported by agile, expert-led clinical execution – empowering smaller companies to succeed globally.

➡️ Smaller, specialized CROs play a greater role in reshaping trial delivery – offering flexibility, continuity, and true partnership where large CRO models may fall short.

 

At ExperTrials, we see each trial not just as a scientific endeavor, but as a promise to patients. Our hope is to help fulfill that promise by making trials smarter, more compassionate, and more accessible across the globe. Happy International Clinical Trials Day!

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