Solutions & services
Celebrating one year of Data Science services at Biotrial
Last year, at Biotrial we took a major step forward to integrate advanced Data Science tools into our everyday clinical research activities following the acquisition of ExactCure, bridging statistics, pharmacology, modeling and AI to accelerate drug development and provide advanced decision-making solutions.
Biotrial’s President and CEO, François Peaucelle, highlights that “in just twelve months, our Data Science team has helped sponsors transform complex datasets into actionable insights, enabling smarter clinical design. In the coming year, we will further expand the use of modeling and real-world data to simulate clinical trials and develop innovative approaches such as synthetic control arms.”
Highlights from year one
In its first year, Biotrial’s Data Science department—bringing together pharmacometricians, mathematicians, data scientists and AI engineers working closely with our biometrics and clinical pharmacology teams—has delivered multiple projects demonstrating the value of data-driven approaches across drug development.
Key achievements include:
- Modeling and simulation of complex endpoints, such as qEEG exposure–response models in early CNS development to support trial design and sample size estimation.
- Population PK modeling to guide dose escalation and regimen selection in first-in-human studies with high inter-individual exposure variability.
- Machine learning approaches to identify drug-induced response patterns in preclinical models, presented at the 2025 Safety Pharmacology Society meeting.
- PBPK modeling to anticipate tissue exposure and support clinical development decisions, including in specific subpopulations.
- AI-driven automation, notably using large language models to support programming quality control and streamline selected operational and administrative processes.
Our vision: advancing clinical research through Data Science
At Biotrial, we believe that intelligent modeling, simulation and AI are transforming the future of drug development. Our Data Science experts support sponsors in exploring variability, optimizing trial design and leveraging all data sources—from clinical trials to real-world data and synthetic datasets.
Our focus continues around three pillars:
1. Modeling: PopPK, PK/PD, PBPK, QSP
- Explore variability in drug exposure and response
- Optimize dosing and sampling strategies
- Support regulatory submissions and communications
2. In-Silico Trials
- Simulate clinical trial scenarios for design optimization
- Form virtual patient cohorts
- Amplify small or rare patient populations
3. Real-World Data (RWD)
- Build external control arms using RWD
- Identify and investigate subpopulations
- Emulate target trials with real-world insights
As we celebrate the first year of Biotrial’s Data Science division, we are proud of the strong foundations built for future innovation. As Stéphanie Le Goaller, Biometrics and Data Science Director, states: “With each project, we push the boundaries of what’s possible in drug development, using cutting-edge science to move R&D forward faster, smarter and more efficiently.” This is only the beginning.
