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What a 10 year mission to become a leading CRO looks like

Julie Ross took the helm of Advanced Clinical over a decade ago. Now, they are one of the largest private CROs in America, and have helped biotechs and pharma in 54 countries take their life-saving drugs from concept to clinic.

Julie Ross, CEO, Advanced Clinical describes the challenges of leading a rapidly growing CRO over the past decade.

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Part of our CEO feature series for Vital Signs, published in Fortune on December 1, 2024

What differentiates Advanced Clinical from other Contract Research Organizations (CROs)?

If you could split the industry into tiers, Advanced Clinical is the best of the tier two CROs. I would describe tier one CROs as focused primarily on profits and return on investment. Big CROs have private equity investors with heavy infrastructure and systematic engines that serve big pharma needs, however, they lack flexibility - they're machines.

We have an entirely different strategy. As a tier two CRO, we work primarily with startups, early biotechs and mid-sized pharma companies, where it’s critically valuable to them that you're not just looking at the bottom line. We offer a personal alternative that’s still comprehensive.

Using our decades of experience, we strive to improve the lives of everyone touched by clinical research and help our clients achieve better outcomes through candid conversations, foresight, resilience and innovative solutions. Our experienced staff has years of experience working with cutting-edge science; the kind of talent you need when developing revolutionary assets in early stage biotechs and smaller pharma companies.

We deliver what biotech clients need, when they need it, guiding them through intricate drug development milestones to bring innovative therapies to market as efficiently as possible. Whether you need comprehensive CRO, FSP, or strategic resourcing services, we work quickly and nimbly through highly customized delivery models. For example, as you build your clinical development plan, we can consult on whether a full-service study or outsourcing specific functions would be more cost-effective. Our flexible approach ensures your unique business needs are met expeditiously and with quality. 

The other big differentiator is our ownership. We do not have venture capital money or private equity in the business. We’re privately held by one owner. Our growth over the last 14 years has all been organic and hard-earned. We focus on the work and the strategy.  Today we offer our clients a comprehensive platform of synergistic services that fit together as we have not had to integrate and piece together disparate acquisitions.

What was your journey to leading Advanced Clinical?

I started working with Radiopharmaceuticals to develop diagnostics and therapeutics. After many years, I decided to venture out seeking to find a rapidly evolving world while still trying to find treatments and cures.

In my search and through networking, I stumbled into a role in clinical research with a startup company that was focused on building one of the world's largest site management organizations. I came into the organization as employee number five, wore lots of different hats and grew very quickly into a corporate officer role where fund-raising and M&A were added to my remit. Over time, we transformed the company from a site management company to a CRO.

I've been at Advanced Clinical since 2013. When I joined, the founder had a contract staffing and FSP business in clinical research, but really wanted to round out the other end of the spectrum, which is full clinical trial outsourcing, so we worked to build that.

Today we generate revenue in 54 countries, 21 legal entities in Europe, Asia Pacific and North America regions and other key countries. We have about 1,000 employees.

I understand you've seen a lot of clinical trials. What types of therapeutics are generating the most interest right now?

Oncology is undoubtedly at the forefront of the market today, and gene therapy is rapidly gaining traction. At Advanced Clinical, oncology is one of our core specialties, and we also have a strong focus on rare diseases. While the majority of our work currently revolves around oncology, we see YOY growing demand in the gene therapy space as well.

Are clinical trials getting more expensive?

I don't see them getting less expensive. I don't see them getting more expensive. I think we're staying neutral on cost.

In our industry, we can be slow to adopt innovation as risks are high in clinical research.  Even when we invest in cost-reducing technology, because of the capital risk of conducting a trial, we often double down using the old and the new.

If I use an analogy, years ago we used to collect all clinical trial data on paper. After electronic data capture methodologies emerged, it took nearly 15 years to shed that paper. Today, while risk-based monitoring approaches are tried and tested, there remain many trials where 100% source data verification is still the norm.   

Yet significant progress in clinical trials has been made in identifying the right patients, thanks to advanced business intelligence and data tools that help us plan more effective trials. Global regulations are also changing, and we can no longer just enroll any patient into a trial. We must ensure the participant demographics align with those of the disease, so that when the trial is complete, the data is truly representative. It's the right thing to do.

Is it challenging recruiting patients for trials, how do you recruit?

It really depends. If you're looking at quality of life or a chronic illness like diabetes, somebody might want to join a clinical trial because of an ad on the radio, television or social media.

But with oncology, when you have a life-threatening disease, most patient recruitment is driven by the treating physician.  Even if a patient uncovers a trial opportunity from various means, they will seek and follow mostly the recommendation of their oncologist. 

Patients typically follow their physician’s recommendations because of the trust they place in them. In these situations, physicians guide and steer their decisions. If that trust weren’t there, patients would seek a physician they do trust. That's why it’s essential to convey a strong message to physicians about these trials, as they play a pivotal role in patient participation.

What is your vision for Advanced Clinical in the near future?

We'll continue our expansion both geographically and with additional service lines. Today we focus on the phase 1 through to phase 3b market and we're investing in new lines of services to provide post-marketing studies and real-world evidence.

In addition, we're doing more with manufacturing companies – especially consulting on workforce solutions – through our staffing arm. I also see the opportunity to invest a lot more in technology, and on the personal level, amplifying community-based patient voices.

Lastly, many oncology products, especially in gene therapy, are showing cross-efficacy in immunology. We anticipate natural growth in this area, driven by our oncology expertise and transferrable knowledge and skills.