EU and U.S. CROs in 2025: Adapting to Evolving Product Testing Protocols

By Lauren Milligan

The development of new technologies for agricultural crops in United States and European Union’s (EU) involves increasing levels of complexity both from a technical and regulatory standpoint. Companies working with contract research organizations (CROs) in these regions are designing protocols that maximize the chances of successful product testing by selecting suitable trial sites and testing conditions to accurately reflect real-world scenarios while keeping regulatory compliance in the process.

Ignacio Colonna

AgriBusiness Global asked Ignacio Colonna, Global Director of Science and Technology for AgriThority, to provide a deeper insight into the outlook for CROs in 2025.

ABG: What are the top three changes that many U.S. CROs made in 2024?

Ignacio Colonna: From our scientists’ perspective, working with many CROs in every region of the U.S., key changes include the addition of drone imagery, adjustments to satisfy changes in regulations, and facility expansions.

Drone imagery is often done with a specialized CRO, but others are strengthening their data collection capabilities to either replace or complement the handheld green sensors used to record NDVI and canopy cover.

Secondly, many are changing their day-to-day functioning and improving their systems to meet the regulatory data requirements.  An example is United States Department of Agriculture (USDA) regulatory trials on genetically modified organisms (GMOs) and new microbial products require more documentation and monitoring during and after the season to contain the GMOs or the microbes within a defined area.

Third, some are improving their infrastructure, adding a greenhouse and laboratory facilities to study the biological input effects on crops under controlled conditions, supplemented with new digital tools aimed for precision phenotyping of crops above the ground and root growth.

ABG: What changes are CROs anticipating for 2025 in the U.S.?

IC: We anticipate CROs will continue to adapt to new types of products as new discoveries are made and adapt to evolving protocols. We expect a continued increase in trials for soil amendments and biological fertilizers in 2025, due in part to increased fertilizer costs and environmental regulations in certain areas. These products are intended to improve nutrient availability from conventional fertilizers or nutrients.

Companies and innovators will have to plan further in advance as novel products require more in-depth planning to ensure the right environmental conditions for their evaluations.

To accommodate, CROs will need to provide more detailed information about their capacity, infrastructure and specific trial locations well in advance of the planting date, including detailed field characterization.  In addition, the level of documentation and verification may continue to increase as compliance regulations rise.

ABG: What are the top three changes that many EU CROs made in 2024?

IC: Across the EU, our scientists observe a positive trend among CROs in adapting to the new and evolving regulatory demands. From understanding the new requirements to tackling the growing challenges of efficacy trials, which include more strict and detailed assessments.

To meet these demands, they continuously invest in new technological tools and refine testing conditions to achieve greater precision in evaluating product efficacy. This is especially relevant due to the increasing number of experimental biosolutions, for which the general patterns of crop response are often different than in traditional chemical products.

For example, the recent implementation of new legislation for biostimulant registration across EU implies the need for controlled trials that generate clean proof of a product mode of action. This implies establishing precise conditions for testing under different nutrient or water conditions, for example.

The integration of drone imagery also improves trial quality control. Providing an objective verification of field-based assessments lessens the variability across trials and improves data credibility.

ABG: What changes are CROs anticipating for 2025 in the EU?

IC: Looking ahead, the challenges that CROs may face include increasing number of competitors, staff turnover, and the continued ambiguity around regulatory rules for registration purposes.

In addition, one key factor for AgriThority has been the increased selection of specialists for certain protocols. For example, certain CROs have developed knowledge and resources especially focused on the evaluation of new herbicides in difficult weeds, others are specialized in crop growth assessment under controlled conditions and yet others focus on the establishment of field-scale trials under real-world farmer management. Understanding the area of specialization for each CRO helps determine which is best suited for each type of experiment.  •

Photo Credits: Ignacio Colonna, AgriThority