Harvest Integrated Research Organization (HiRO) and Differentia Biotech have signed a memorandum of understanding (MoU) outlining plans for a strategic partnership focused on clinical trial simulation.

The agreement was formalised at an event at HiRO’s office, as the two companies aim to combine expertise in clinical operations and AI-powered modelling to offer new solutions for biopharmaceutical sponsors.

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Both HiRO, a full-service global clinical research organisation, and Differentia Biotech, a company specialising in modelling and simulation for drug development, intend to jointly develop advanced clinical trial simulation models.

The collaboration will integrate HiRO’s experience in data science, real-world data services, and global clinical operations with Differentia’s digital twin and simulation platforms.

These simulation-driven approaches are designed to support improved trial design, optimise patient selection, and potentially reduce participant numbers, with a goal of enabling better decision-making early in drug development.

The partnership aims to address challenges faced by biotechnology firms, especially cost pressures and the need for more efficient trial timelines.

HiRO stated that they will develop new commercial products and service offerings using their combined simulation capabilities.

HiRO CEO and founder Karen Chu said: “Drug developers don’t just need faster trials, they need smarter ones. Differentia’s modelling and simulation expertise complements the operational discipline HiRO brings to every study, and this collaboration lets us explore how those strengths work together for the clients we both serve. We are aiming to support our biotech clients in better decision-making.”

The initiative will focus on a range of therapeutic areas, including oncology, rare diseases, cell and gene therapy, and radiopharmaceuticals.

HiRO has previously managed trials for small, mid-size, and large biotechnology and pharmaceutical clients, delivering trials across 85 countries with more than 500 professionals.

Differentia Biotech is based in San Francisco and develops AI-driven digital twin and decision intelligence platforms for the life sciences industry.

Further details regarding forthcoming projects under the new partnership are expected to be shared as work progresses.

In December 2024, HiRO announced a strategic partnership through the signing of a MoU with CHA University Bundang Medical Center (CBMC) to deliver comprehensive solutions to pharmaceutical and biotech companies globally, covering all phases of clinical trials (Phase I to Phase IV).