Before the raise: Why early CRO engagement matters for Biotech innovators

By Mike Baker – EVP Business Development

“Let’s get the financing done and then we will source CRO’s” – I hear this in many early-stage biotech conversations.

It makes sense. When you’re running a company with a small team and a finite cash runway, everything feels tied to the raise. The science has to resonate, the milestones have to look achievable, the plan has to be capital efficient.

But in practice, by the time a raise closes, execution questions are already surfacing. Not because the science has changed, because clinical development rarely unfolds the way it looks on a PowerPoint slide.

Recently, a CEO I spoke with reflected that lining up the CRO early during the financing process, helped demonstrate operational readiness for their sale. It signaled that the clinical plan had been pressure-tested, not just modelled.

Trial costs are often assumed to be driven by large line items. In reality, costs often grow through small, unattributable decisions that stack up. Without integrated governance from the start, cost and burden can multiply long before the first patient is enrolled. That’s why early operational alignment is often one of the most effective ways to protect total program cost. It prevents avoidable rework before it becomes expensive.

The earlier variables are pressure-tested, the stronger and more capital-efficient the plan becomes.

Effective partnership starts before the contract

The most impactful early conversations I have with biotech teams are not the transactional ones. They are strategic, focused on the aims and trajectory of the program rather than the mechanics of the first study. Answering questions like:

• How will the protocol decisions you’re making now influence future phases?
• If the asset shows signal, how easily can you scale?
• What operational choices today might create friction later?
• How will early regulatory strategy choices influence your ability to activate sites across regions later?

Engaging a CRO early isn’t just about signing a work order. It’s about bringing in experienced teams who can answer these questions quickly, pressure-test assumptions, and help prevent avoidable rework. That early alignment often reduces downstream cost by avoiding amendments, duplicated vendor activity, or operational decisions that are expensive to unwind once a study is underway.

Agility matters when capital is tight

For emerging biotechs, flexibility is not a preference. It means survival. Enrollment may be slower than modelled. A regulatory authority may request clarification. An amendment may be required. The expansion of the cohort may become strategically important. These shifts are common, particularly in complex therapy areas such as oncology, neurology, and rare disease. The question is not whether change will occur. It’s how quickly and easily you can adapt to the changes that will happen.

An agile CRO is not defined by speed alone. It’s defined by intelligent adaptability, short decision lines, accessible leadership, and operational teams who understand the scientific context well enough to pivot without losing momentum.

Global thinking tends to show up earlier than expected

Many clinical-stage companies begin with a single-region focus, then find that patient access, investigator expertise, or strategic considerations prompt them to expand across borders sooner than planned. Cross-border execution introduces fresh nuances. Regulatory expectations differ, and site activation dynamics vary. Even documentation standards can influence timelines in subtle ways.

You don’t need to operationalize globally on day one. But understanding how early protocol and sequencing decisions affect future expansion is highly valuable from the outset. That perspective becomes part of the partnership, not an afterthought. Working with a CRO that can operate across the US and Europe as one integrated team helps keep those differences from turning into delays.

The quiet advantage of early alignment 

When a biotech engages a CRO only after funding, the relationship starts under pressure. Contracts need to be signed while trial timelines must be met. Teams need to mobilize quickly. When engagement starts earlier, the relationship develops differently. There is time for open discussion, challenge assumptions and build trust.

The strongest clinical-stage companies I see don’t just present compelling science. They present a development plan that has been questioned, refined, and grounded in execution experience. This doesn’t eliminate risk. But it reduces avoidable surprises.

Engaging a CRO earlier than you think you need to isn’t about accelerating spend. It’s about strengthening strategy. It also supports capital efficiency by reducing amendments, delays, and other avoidable sources of downstream cost.

Clinical development is a long journey. The right partner isn’t there just for the start, but throughout the development pathway, helping you adapt as science, regulation, and capital realities evolve. If you’re preparing for a raise and mapping your first clinical study, it’s worth pressure-testing the plan now, not after the money lands.