What Regulators Expect from CRO Data on the Path to Commercialization

At the end of the year, we love looking back at what we have worked on over the last year. It is always rewarding to see products that we contributed to entering the market and helping our industry out. The road to commercialization and sharing these products is a long arduous one. From bench top to pilot study, to GLP & GCP trials, launching a product to market with regulatory approval is a quality driven process with many checkpoints and protocols in place to prevent issues. One of the reasons companies work with us is our understanding of what regulators expect from data. This knowledge can mean the difference between a smooth approval process or costly delays. While innovation drives our industry forward, it is credible, well-structured data that ultimately enables commercialization.

Based on regulatory guidance and our practical experience supporting submissions, here’s what regulators are looking for and how we can help you meet those expectations.

1. Scientific Rigor and Transparency

Is the work scientifically sound, reproducible & clearly documented – these are the three key expectations from all regulators when looking to bring a product to market. Trials must be designed to withstand independent review, not just internal decision-making.

This includes:

• Clearly defined objectives and hypotheses

• Robust experimental design with appropriate controls and replication

• Transparent methodologies that can be reviewed and understood by third parties

2. Relevance to Intended Use

Although it may seem obvious to most, a common gap in regulatory applications is data not fully aligned with the product’s intended commercial use. Studies should be designed with the end-use claim in mind from the outset. If the data being presented doesn’t portray this, regulators will reject it, resulting in a delay to market, more testing requirements and more expenses prior to launch.

Regulators assess whether:

• The species, life stage, and production system are appropriate

• Trial conditions reflect realistic commercial environments

• Dosage, application method, and duration mirror real-world use

3. Data Integrity and Traceability

“Bad data is no data,” is a famous saying from our Director of Aquatic Research, Dr. Fabio Zanuzzo. Not all data is created equal, and data collection or handling methods are closely scrutinized by regulators.  Strong data governance builds confidence in the validity of trial outcomes.

They expect:

• Consistent monitoring and standardized data collection procedures

• Complete traceability from raw data to results

• Clear documentation of deviations and corrective actions

4. Statistical Validity and Interpretation

When we develop trial design with clients, the communication on replication is always an important one. Details regarding tank, fish, and sample numbers are what provide strength to statistical analysis. Data must not only be collected properly, but we must also analyze it appropriately. Overstated claims or weak statistical justification can quickly undermine an otherwise well-executed study.

Regulatory reviewers look for:

• Adequate sample sizes and statistical power

• Pre-defined endpoints and analysis plans

• Conclusions that are fully supported by the data

5. Independent and Objective Execution

When we start a trial, we start it with the intention of learning something new. We are neutral in expectations for the outcome of a trial with the primary objective being to understand the impact of the treatment for the species we are working with, even if there is no impact. We are expected to provide data that is objective and independent, without clear commercial bias to the outcome. As a CRO, our client’s goals are our goals, but we don’t have the commercial gain in the outcome which allows us to follow the science. Objective results enhance credibility and reduce regulatory risk.

This means:

• Neutral trial execution free from commercial bias

• Clear separation between product performance and marketing language

• Balanced reporting of both positive and negative findings

6. Comprehensive and Clear Reporting

As submission volumes grow, clarity becomes critical. It is more important than ever to have well-structured, clearly documented data for reviewers to quickly understand study intent, methods, and outcomes. Even when the science is sound, poorly organized or inconsistently reported data can delay approvals. Well written reporting creates ease for regulators, helping to move approvals along with minimal need for clarification.

Effective reports include:

• Logical structure and clear summaries

• Transparent discussion of limitations

• Data presented in a way that supports efficient regulatory review

At Onda, we can help design and execute your aquaculture studies with commercialization as the end goal to support your product launch with data that meets regulatory standards while remaining grounded in real-world production conditions. If you’re planning studies to support regulatory approval or commercial claims, aligning early can make all the difference.