The Altiora Perspective

What It Was Like Building a CRO When Clinical Research Barely Existed

25 years ago, starting a CRO in Croatia wasn't considered ambitious. It was considered impossible.

When I entered clinical research in 1997, Good Clinical Practice (GCP) had only recently become the foundation of modern clinical trials. There were very few people in Croatia—or anywhere in the region—who had practical experience in clinical research.

A handful of bioequivalence studies were being conducted at a few specialised centres, but those were relatively straightforward projects. The concept of a full-service Clinical Research Organisation was virtually unknown.

Looking back today, it's difficult to explain just how different the environment was.

Not only was there little experience.

There was almost no understanding of what clinical research actually was.

Becoming the First CRO

In January 2001, after more than three years working for a global CRO, I decided to establish my own company.

What happened next still makes me smile.

The Commercial Court had no idea how to register the business because there was no recognised business activity that described what we intended to do.

The Ministry of Health didn't know either.

It took four months before they finally responded to the Court.

Not because they disagreed.

Simply because nobody knew how to classify a Clinical Research Organisation.

As far as I know, Altiora became the first CRO established in Croatia.

Today, that sounds like an interesting historical detail.

At the time, it simply meant that every step forward required creating something that didn't previously exist.

Before We Could Run Studies, We Had to Build Knowledge

The first challenge wasn't finding clients.

It wasn't winning projects.

It wasn't competition.

The first challenge was education.

We had to educate investigators.

We had to educate study coordinators.

We had to educate monitors.

We even had to educate regulators.

When you're building an industry from the ground up, there are no shortcuts.

You quickly discover something unexpected:

The fastest way to become an expert is to teach others.

Preparing presentations, answering difficult questions and explaining concepts over and over again forces you to understand every detail yourself.

Looking back, I realise that those years gave me something incredibly valuable—not just knowledge in one area of clinical research, but an understanding of the entire journey, from concept to market.

That broad perspective still influences the way we approach projects today.

A Different Time

Starting a company in 2001 was difficult.

But in some ways, it was also surprisingly simple.

If you had knowledge, a computer and an internet connection, you had almost everything you needed.

Today's entrepreneurs face a completely different reality.

Modern regulations, quality systems, GDPR requirements, validation, cybersecurity, vendor qualification and countless compliance obligations mean that building a CRO now requires significant infrastructure before the first project even begins.

Not only equipment.

Not only software.

But quality systems, documented processes and experienced personnel—many of whom generate costs long before they generate revenue.

It creates a difficult paradox.

To win projects, you need experience, qualified staff, validated systems and an established infrastructure.

But without projects, building all of that requires substantial investment.

The barrier to entry has become dramatically higher than it was twenty-five years ago.

The Right Moment in Time

There was another factor that helped clinical research grow across Croatia and the wider

region.

Investigators were curious.

They were motivated.

Clinical trials were still something new.

Patients trusted their physicians, and physicians were genuinely interested in bringing innovative treatments to their hospitals.

That trust became one of the greatest engines of clinical research in the region.

Even regulatory timelines—which at the time often felt frustratingly slow—were rarely the biggest obstacle.

The real opportunity lay elsewhere.

There were motivated investigators.

Engaged patients.

And an entire industry waiting to be built.

Looking Back

When people ask what made those early years successful, they often expect me to talk about strategy, business plans or market opportunities.

The truth is much simpler.

We were fortunate to begin at a moment when knowledge mattered more than infrastructure.

When relationships mattered more than systems.

When enthusiasm often compensated for the lack of experience.

Those circumstances no longer exist.

But the lessons remain.

And perhaps that is the greatest advantage of having been there from the beginning.

To be continued…

In the next article, I'll share how the industry evolved from a small regional community into today's highly regulated global ecosystem—and why, despite all the technological advances, clinical research remains above all a business built on people.

The Altiora Perspective

A personal reflection by Josip Aralica, MD, Founder & CEO of Altiora.