When To Build Out Your ClinOps Team — And Other Advice For First-Time Biotechs

By Jessica Cordes, Senior Consultant, Clinical Excellence GmbH

For a small biotechnology company, preparing to enter clinical development changes much more than the development stage of its lead asset. It changes the responsibilities of the organization.

During the preclinical phase, a company may operate successfully with a relatively small internal team supported by laboratories, consultants, manufacturers, and other specialized partners. As the first clinical trial approaches, however, the company becomes responsible for activities that directly affect clinical trial participants, data reliability, regulatory compliance, and, ultimately, the credibility of its development program.

This creates an important organizational question: How much clinical operations capability does a small biotech actually need?

One possible strategy is to build a conventional clinical operations department. Another is to outsource almost everything to a CRO. In my experience, neither extreme is usually the right starting point.

A small biotech does not have to reproduce the infrastructure of a large pharmaceutical company before enrolling its first patient. It does, however, need sufficient internal competence, governance, processes, and sponsor oversight to act as an informed and effective sponsor.

The objective, therefore, should not be to build the largest clinical operations department the company can afford. It should be to build the right sponsor organization for the clinical trial the company intends to conduct.

Becoming A Sponsor Is An Organizational Transition

The transition into clinical development is sometimes treated primarily as a regulatory milestone. The team prepares regulatory submissions, it appoints service providers, and it selects sites. The organization works towards first patient in, and the protocol progresses.

However, the underlying transition is broader.

The organization must now bring regulatory, medical, clinical operations, quality, manufacturing, pharmacovigilance, data management, statistics, and other functions together around a clinical development program. Clinical operations often sits at the center of many of these interfaces, but that does not mean clinical operations should own every activity. It means someone needs to understand how the different activities connect and identify gaps before those gaps affect the clinical trial.

A CRO can provide substantial operational resources, but outsourcing operational activities does not remove the need for an internal sponsor organization capable of understanding what is happening and making appropriate decisions.

Start With Capabilities, Not Headcount

One of the first questions I hear from growing biotech organizations is: Which positions do we need to hire?

I prefer to start with a different question:

Which capabilities do the company need to fulfil its responsibilities and successfully execute the first clinical trial?

The difference is important. A capability does not automatically equal one full-time employee. Some capabilities may require permanent internal ownership. Others may be supplied through experienced consultants, CROs, functional service providers, or specialist vendors.

For a company approaching its first clinical trial, necessary capabilities may include clinical development planning, clinical project management, monitoring oversight, service provider governance, feasibility and site strategy, budget and timeline management, risk management, quality management, document management, regulatory coordination, investigational medicinal product interfaces, data and safety oversight, and inspection readiness.

The exact model should reflect the company strategy. Therefore, the organizational design should follow the risks and complexity of the clinical trial, rather than a generic industry organization chart.

This principle is also consistent with risk-based sponsor oversight. ICH E6(R3) calls for oversight measures that are fit-for-purpose and tailored to the complexity and risks of the clinical trial. It also emphasizes designing clinical trials that are operationally feasible and avoiding unnecessary complexity, procedures, and data collection.

That same proportional thinking is useful when designing the sponsor organization itself.

Decide What Must Stay Inside

The next question is therefore not simply: What can we outsource?

It is: What knowledge and decision-making ability must remain available to the sponsor?

A useful principle is to keep strategic ownership and informed decision-making close to the company, while using external expertise and operational capacity where it adds value. Someone within, or directly representing, the sponsor organization must be able to challenge CRO assumptions. They need the capacity to ask:

Why were these countries selected? Why are these sites appropriate? Is the recruitment forecast realistic? Which protocol procedures are creating unnecessary operational burden? Which key performance indicators actually matter? What constitutes a significant deviation from the plan? When does an issue require escalation?

Those questions require clinical operational expertise, not simply status reporting.

Country selection, for example, should integrate input from functions including medical, regulatory, operations, production, and laboratories, rather than being treated as an isolated approach. It identifies factors such as market considerations, patient populations, therapy experience, regulations, and operational feasibility as relevant to country assessment. A lean sponsor, therefore, needs people who can connect information across functions and translate it into decisions.

Outsource Execution, Not Understanding

For small biotech companies, outsourcing is often the most sensible way of obtaining specialized expertise and scalable capacity without creating a large permanent organization. The problem starts when outsourcing becomes a substitute for sponsor knowledge.

A CRO may conduct monitoring, manage sites, and coordinate clinical trial activities. Specialist providers may support data management, pharmacovigilance, central laboratory services, imaging, logistics, electronic systems or manufacturing interfaces. But the sponsor still needs to understand whether those activities meet the regulatory requirements.

Service provider selection should consequently assess more than price and available resources. The sponsor should consider the service provider's relevant experience, systems, quality approach, communication model and ability to work within the intended governance structure.

Service provider governance should then continue after contract signature. The sponsor should establish defined responsibilities, interfaces, escalation pathways, key deliverables, meeting structures, and decision rights early. Otherwise, a lean outsourcing model can quickly create fragmented accountability. In practice, the CRO should increase the sponsor's capacity. It should not become the only organization that understands how the clinical trial works.

Make Risk Management Part Of Operations

A lean clinical operations organization cannot control every activity with the same intensity. Nor should it. Risk-based thinking helps the sponsor place attention where failure would matter most.

Sponsor oversight is linked with identifying, evaluating, controlling, communicating, and monitoring risks that may affect participant safety or data reliability. Practically, this means identifying critical processes, records, and data early and designing sponsor oversight accordingly.

For one clinical trial, product handling may be a major operational risk. For another, recruitment, eligibility assessment, endpoint evaluation, data flow, or a critical external service provider may require closer attention. And the risk profile can change throughout a clinical trial as well.

A service provider that performs well during start-up may experience capacity problems later. An initially unrealistic recruitment assumption may become visible after site activation. A manufacturing change may introduce new operational dependencies.

Risk management therefore should not be a document created at clinical trial start and subsequently filed away. It should influence routine clinical project management and sponsor decisions throughout clinical trial conduct.

Do Not Underestimate Training

Moving into clinical development also changes what employees need to know. Not everyone needs to become a clinical operations specialist. But people whose work affects the clinical trial should understand their responsibilities, relevant procedures, escalation expectations, and the fundamental principles of GCP appropriate to their role.

Training should also prepare people to act. Knowing that an SOP exists has limited value if an employee does not know when to escalate an issue, which decision belongs to the sponsor, or what information needs to be documented. This is particularly relevant in small companies where individuals may cover several responsibilities.

Know When The Organization Needs To Grow

A lean structure is not a static structure. The operating model that supports the first clinical trial may not be sufficient when the company adds countries, clinical trials, indications, or products.

Growth should be driven by operational need and risk. If sponsor oversight consumes increasing leadership capacity, additional internal clinical operations expertise may be justified. If several clinical trials create competing priorities, dedicated project leadership may become necessary. If specialist processes become strategically important across programs, bringing specific expertise inside may make more sense than repeatedly purchasing it externally.

The question should be reviewed periodically: Which capabilities now need permanent internal ownership, and which can still be provided effectively through external partners?

This gut-check allows the organization to mature deliberately instead of accumulating positions in anticipation of needs that may never materialize.

Test Clinical Readiness Before First Patient In

Before moving from planning into execution, leadership should be able to answer the following fundamental questions with confidence:

• Who has operational ownership of the clinical trial?
• Which activities are outsourced, and who oversees each service provider?
• Are responsibilities and decision rights clear?
• Are the essential processes usable?
• Are critical risks understood?
• Can the organization identify and escalate emerging issues?
• Do people have appropriate training?
• Are clinical systems and document flows controlled?
• Are clinical operations, medical, quality, regulatory, manufacturing, and other relevant functions aligned?

If those questions cannot be answered clearly, hiring another clinical project manager may not solve the problem. The gap may be organizational rather than numerical.

Small Does Not Have To Mean Underprepared

Building clinical operations in a small biotech requires discipline precisely because resources are limited. The objective is not to imitate Big Pharma on a smaller scale but to create an operating model that is appropriate for the first clinical trial.

That model can be lean. It can rely extensively on specialist external partners. It can evolve as the portfolio progresses. But it still needs internal knowledge, clear accountability, appropriate processes, effective vendor governance, trained people, and risk-based sponsor oversight.

The most successful transition from a preclinical company to a clinical sponsor is defined by whether the sponsor knows what needs to happen, who is responsible, where its important risks are, how it knows that outsourced activities are being performed appropriately, and when it needs to intervene.

Build those capabilities first. Then build the department as the first clinical trial and the clinical development program later actually requires it.

About The Author:

Jessica Cordes is a clinical operations expert and founder of Clinical Excellence GmbH with more than 15 years of experience planning, governing, and executing international clinical trials, with a focus on oncology and cell and gene therapies. She supports small biotech sponsors in building practical, GCP-compliant structures for clinical trial planning, start-up, sponsor oversight, vendor management, risk management, and operational decision-making. The benchmark report “Global Clinical Trial Approval and Setup Timelines” reflects her focus on translating regulatory requirements into usable planning guidance for global clinical trial teams. Since 2023, Jessica has worked as an independent consultant and trainer and provides GCP training, templates, and practical implementation support through the Clinical Excellence Training Academy.