Gastroenterology Clinical Trial Services

Trust the GI Experts

It’s simple: No other CRO brings the same specialized focus and proven success in GI trials.

With GI as our why, we’ve dedicated every study, every site strategy, every data model, and every operational process to advancing gastrointestinal research:

30+ years leading GI research and clinical trials
5,000+ sites in 60+ countries across our network
Supported >70% of IBD compounds in development

Discover what our team can do for your trial.

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Plan a Successful Program

Set a strong foundation with early medical, clinical, and operational planning tailored to complex GI diseases:

Clinical development strategy

We design clinical trials based on deep therapeutic expertise and your specific goals, ensuring your protocol is scientifically sound and operationally viable

Clinical development strategy

Clinical trial design & protocol development

We design trials that are operationally feasible for sites, minimize patient burden, and align with regulatory expectations; we also build clear, viable protocols that reduce deviations, reflect patients’ priorities, and protect data quality

Clinical trial design & protocol development

Medical writing

We write clear and compliant protocols — IBs, ICF, CSRs — prepared according to ICH and regional guidelines

Medical writing

Run a Smooth Study

Ensure coordinated oversight, clear communication, and proactive management with operational excellence grounded in GI expertise:

Clinical project management

Our expert GI project managers provide proactive planning, decisive leadership, vendor oversight, and transparent communication to keep studies on track

Clinical project management

Site engagement

Backed by data, we target high-performing GI sites from our global network of 5,000+ locations across 60+ countries

Site engagement

Site management and risk-based monitoring

We provide sites with the GI-specific support, training, and oversight they need to sustain operational momentum, protect patients, and ensure high-quality data

Site management & RBM

Safeguard Patients and Compliance

Ensure participant safety and maintain the utmost data integrity:

Medical monitoring

Our medical monitors review eligibility, safety data, and provide protocol guidance to ensure trial integrity

Medical monitoring

Clinical safety

We develop a study-specific safety management plan that outlines roles and responsibilities, case processing timelines, and all safety reporting requirements

Clinical safety

Regulatory strategy

Our regulatory strategy experts specialize in GI clinical trials, guiding you through complex requirements with precision planning and seamless coordination

Regulatory strategy