February 3, 2025 – Alimentiv Inc., a global full-service GI Contract Research Organization (CRO), announced today it has entered a strategic partnership with PhaseV, a pioneer in software and machine learning (ML) for clinical trial optimization, to support the optimal design and execution of advanced adaptive clinical trials for a range of GI conditions. These trials will focus on inflammatory bowel disease (IBD), celiac disease (CD), eosinophilic gastrointestinal disease (EGID) and other related disorders. 

The collaboration has the potential to accelerate the development of new GI therapies by leveraging adaptive trial methodologies that improve efficiency and outcomes for patients facing these challenging conditions.

“Gastrointestinal diseases are on the rise, contributing to hundreds of thousands of deaths and costing an estimated $136B annually in the U.S. alone,” said Pierre Gaudreault, CEO of Alimentiv.1 “By combining our GI expertise with PhaseV’s advanced machine learning capabilities for trial simulation, design, and execution, we intend to significantly improve clinical study efficiency and outcomes. This will accelerate success for our sponsors and help address the growing burden of GI diseases more effectively.”

Designing and executing randomized control trials (RCTs) in the field of GI presents significant challenges. These include patient heterogeneity, high placebo response rates in conditions like Inflammatory Bowel Disease (IBD, rising study costs, and lengthy trial timelines, all of which place strain on trial sponsors and hinder the discovery of new treatments. Advanced trial designs, such as adaptive designs, can help overcome these challenges by leveraging accumulating data throughout a trial to optimize design and execution. 

The collaboration incorporates PhaseV’s proprietary adaptive clinical trial technology with Alimentiv’s end-to-end GI clinical trial service offerings. The solution enables the optimal design of adaptive trials to meet the needs of these studies with seamless execution, helping pharmaceutical and biotech companies overcome the inherent challenges of current designs.

“GI clinical trials have historically been limited by challenges such as patient variability, complex disease mechanisms, and a lack of validated biomarkers. These challenges often complicate efficacy assessments of new treatments and lead to trial failure,” said Raviv Pryluk, PhD, CEO and Co-founder of PhaseV. “Aligning our ML platform with Alimentiv’s GI trial leadership will help trial sponsors overcome these challenges, enabling more robust trial designs and execution that increase the likelihood of success.”

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About Alimentiv Inc.

Alimentiv is a leading specialty GI-focused CRO advancing frontiers of gastrointestinal (GI) clinical trials and medical research since 1986. As a global CRO offering clinical, medical imaging and precision medicine services, Alimentiv partners with pharmaceutical and biotechnology industries to advance the development of novel therapies and accelerate their time to market. Alimentiv is headquartered in London, Ontario, Canada, with a global footprint across its operations in Canada, the United States, Europe, Asia-Pacific, and Latin America.

For more information, visit: www.alimentiv.com.

About PhaseV

Leveraging the power of advanced causal inference and pushing the boundaries of ML, PhaseV detects hidden signals in clinical data and extracts actionable insights for planning the optimal next steps. The company’s technology enables optimal design and closed-loop execution of adaptive clinical trials, increasing efficiency and success rates. PhaseV is advancing paradigm shifts in the clinical trial world in order to bring new treatments to more patients in a more precise and efficient way.

Learn more at www.phaseVtrials.com and follow us on LinkedIn.

1Gastrointestinal diseases in America: The costly impact on employers and patients – Oshi Health