Respiratory Medicine

Respiratory trials rely heavily on pulmonary function tests (PFTs), imaging, and biomarkers, all of which can vary widely depending on technique, equipment, and patient effort.

iNGENū addresses this pain point with Standardised Respiratory Assessments

We ensure consistency through centralised training of clinical staff, standardised protocols for spirometry and imaging (e.g., HRCT, PET), and the use of advanced biomarker analysis to ensure reliable, high-quality data collection across all trial sites.

Respiratory trials, particularly for conditions like asthma and COPD, are highly susceptible to placebo effects and variability in symptom severity, complicating data interpretation.

iNGENū addresses this pain point with Robust Trial Design and Advanced Analytics

Our trials are carefully designed with robust blinding methods and include run-in periods and crossover designs where appropriate. Advanced statistical methodologies are employed to account for variability and placebo effects, ensuring precise and credible results.

Recruiting patients with chronic respiratory conditions can be challenging, as these populations often have comorbidities and varying degrees of disease severity, impacting their ability and willingness to participate.

iNGENū CRO addresses this pain point with Targeted Recruitment Strategies

We leverage extensive patient databases, collaborations with respiratory specialists, and connections with patient advocacy groups. Our patient-centric approach includes flexible visit schedules, remote monitoring options, and robust patient support systems to maximise recruitment and retention.

Respiratory medications often have systemic effects or require inhalation or infusion methods, increasing the importance of vigilant monitoring for adverse events and patient safety.

iNGENū addresses this pain point with Comprehensive Safety Protocols

Our safety monitoring systems are state-of-the-art, providing real-time surveillance and prompt intervention for adverse events. A dedicated safety oversight committee regularly reviews safety data, ensuring rapid response and transparent communication with all stakeholders to prioritise patient well-being.

Trials involving novel biologics, inhalation devices, or advanced therapies in pulmonology face complex regulatory landscapes requiring meticulous documentation and compliance.

iNGENū addresses this pain point with Regulatory Expertise

Our regulatory affairs specialists are highly experienced in pulmonology-specific submissions, including INDs, NDAs, and device approvals. We provide end-to-end support to navigate regulatory pathways efficiently, reducing delays and accelerating trial progression.