Experience
Transforming Respiratory Trial Endpoints with Precision and Insight
Respiratory diseases present unique challenges: heterogeneity of pathophysiology, variable patient response, and traditional endpoints that may lack regional or mechanistic specificity. Banook provides advanced solutions that deliver deeper insights into lung structure and function through:
Functional Respiratory Imaging (FRI): A proprietary, non-invasive technique combining low-dose high-resolution CT and computational fluid dynamics to generate 3D, patient-specific biomarkers of airway geometry, airflow, ventilation distribution, aerosol deposition, and more — enabling precise assessment of disease mechanisms and therapeutic effects at regional and whole-lung levels.
Pulmonary Function Testing (PFT): Standardized, high-quality assessment modalities including spirometry, Fractional exhaled Nitric Oxide (FeNO), oscillometry, and Diffusion Capacity for Carbon Monoxide (DLCO), collectively capturing airflow limitation, airway inflammation, mechanical properties, and gas-exchange capacity with robust operational performance across sites.
Together, these modalities form a comprehensive respiratory endpoint toolkit—enhancing sensitivity to treatment effects and supporting strong regulatory strategies.
IN-SILICO TRIALS & DIGITAL ENDPOINTS
Computational Inhalation Modelling & In-Silico Trials
Advanced Computational Fluid Dynamics (CFD) and Rapid Deposition Analysis (RDA)-based modelling frameworks leveraging patient-specific airway geometries and inhalation profiles to quantify regional aerosol deposition, flow dynamics, and exposure metrics for inhaled drug delivery.
These digital endpoints support drug development and bioequivalence assessments, complement clinical data, reduce reliance on imaging or invasive studies, and enable mechanistic, regulatory-ready insights—supported by high-quality scientific visualizations—across development stages.
Medical experts
A Global Network of Pulmonary Leaders
Banook is backed by an international panel of pulmonary experts and key opinion leaders who support trial teams across scientific, operational, and regulatory domains:
Respiratory Methodology & Endpoint Design: Collaborative protocol development integrating imaging and functional readouts tailored to mechanism, indication, and phase.
Expert Interpretation & Advisory: Accessible pulmonary clinicians and imaging scientists provide consultative support on biomarker selection, interpretation, and clinical relevance.
Regulatory Alignment: Guidance on endpoint justification and alignment with regulatory expectations for respiratory drug and device development.
Our experts partner with sponsors from first-in-human through Phase III and post-market studies, ensuring methodological rigor and continuity of insight throughout the clinical program.
Challenges
Reducing Variability and Increasing Precision
Respiratory trials often face hurdles such as high variability, limited sensitive endpoints, and difficulty demonstrating regional effects in heterogeneous disease populations. Banook Respiratory addresses these through:
Increased Endpoint Sensitivity: FRI biomarkers capture structure–function relationships and therapeutic impact beyond global lung metrics, enabling earlier and clearer differentiation between arms.
Deep Physiologic Insight: Quantitative regional measures of airway resistance, ventilation distribution, and aerosol deposition provide mechanistic insights that inform dose selection and responder profiling.
Comprehensive Functional Readouts: Combining imaging with PFTs such as FeNO for airway inflammation, oscillometry for small-airway mechanics, and DLCO for gas-exchange efficiency allows multidimensional characterization of respiratory response.
Standardized, High-Quality Data Across Sites: Robust operational frameworks ensure PFT quality control, imaging protocol harmonization, and consistent endpoint performance in multinational studies.
Solutions Tailored to Your Study Needs
Building Stronger Respiratory Trials
Banook supports a wide range of respiratory indications — including asthma, COPD, cystic fibrosis, interstitial lung disease, and other obstructive or restrictive conditions — across all phases of clinical development. Our solutions include:
FRI Biomarker Generation & Analysis
Centralized Pulmonary Function Testing Services
Imaging Protocol Development & Quality Assurance
Endpoint Interpretation & Reporting
Integrated Respiratory Data Streams for Regulatory Submissions
Together, these services enable sponsors to build more informative respiratory trials with endpoints that matter to patients, clinicians, and regulators alike.
Devices
Why Banook for Respiratory
Your Partner in Respiratory Clinical Development
With the integration of Fluidda’s 20+ years of leadership in Functional Respiratory Imaging, Banook is uniquely positioned to deliver an unmatched respiratory clinical trial capability — coupling innovative imaging science, comprehensive functional testing, and deep pulmonary clinical expertise.
Whether your program targets novel biologics, small molecules, inhaled therapies, or medical devices, Banook Respiratory offers a scientifically rigorous and operationally scalable solution designed to enhance decision-making and support successful outcomes.
