Respiratory CRO Services
Breathe easy with pivotal study solutions built for respiratory clinical trials
Respiratory clinical trials require a light touch to manage complex protocols, high screen failure rates, and increasingly diverse patient populations. PSI offers a rigorous, science-driven approach with expertise in COPD, IPF, asthma, pneumonia, and other respiratory diseases, navigating protocol requirements, site capabilities, and patient needs to deliver your study on time.
6
respiratory drug approvals
10,000+
patients enrolled
50+
late-stage respiratory studies
PSI Respiratory Clinical Trial Expertise
Indications
Obstructive Airway Diseases
- Bronchial Asthma
- Chronic Obstructive Pulmonary Disease (COPD)
Interstitial and Fibrotic Lung Diseases
- Idiopathic Pulmonary Fibrosis (IPF)
- Other Interstitial Lung Diseases (ILDs) e.g. associated with autoimmune or environmental causes
Pulmonary Infections
- Bacterial and viral Pneumonias
- Community-Acquired Bacterial Pneumonia (CABP / CAP)
- Hospital-Acquired Pneumonia (HAP)
- Ventilator-Associated Pneumonia (VAP)
- Viral Pneumonias
- Pulmonary Infections in immunocompromised Patients
- Fungal Pulmonary Diseases
- Invasive Pulmonary Fungal Infections in Lung Transplant Recipients
- Infectious Agents
- Influenza Virus
- Respiratory Syncytial Virus (RSV)
- Chlamydia pneumoniae
- Multiresistant Gram-negative Bacteria, e.g. Acinetobacter baumannii
- Fungi
Respiratory Critical-Care Medicine
- Acute Respiratory Distress Syndrome (ARDS)
Hereditary Lung Diseases
- Cystic Fibrosis
Lung Cancer
- Small Cell Lung Cancer
- Non-small Cell Lung Cancer
Mechanisms of Action
Anti-Infective Agents
- Broad-Spectrum and Narrow-Spectrum Antibiotics, e.g.
- Macrolides
- Tetracyclines
- Fluoroquinolones
- Cephalosporins
- Rifamycins
- Quinolinones
- Antifungals
- Azoles (including inhaled azole formulations)
- Antivirals and Vaccines
- Influenza Virus Vaccines
- Humanized Monoclonal Antibody
- Vaccine platforms for respiratory pathogens
- Bacteriophages
Anti-Inflammatory, Immunomodulatory, and Anti-Fibrotic Agents
- Anti-inflammatory Drugs, e.g. Glucocorticoids
- Anti-fibrotic Agents
- Imunosuppressive Drugs
Bronchodilators
- Adrenergic Receptor Agonists
- Anticholinergics
Targeted Therapies
- CRTH2 (DP2) Antagonists
- Non-peptide Agonists of Angiotensin II Type 2 Receptor (AT₂R)
- Dopamine Receptor Agonists
Devices and Drug–Device Combinations
- Inhalation and Nebulization Systems
IPF Clinical Trial Expertise
IPF trials face significant barriers, from the rarity of the disease and complex comorbidities in elderly patients, to strict eligibility criteria and a competitive landscape with over 30 ongoing studies. Successfully enrolling and executing these studies takes a CRO with deep operational experience and flexibility. PSI’s track record demonstrates our ability to keep IPF trials on schedule and help accelerate your new therapy to patients in need.
We focus on selecting sites with robust patient databases, access to HRCT units, experience with central reading, and proven commitment to research. Because consistent, accurate spirometry data is crucial for ILD trials, PSI ensures reliable endpoints and regulatory confidence through rigorous site qualification, continuous training, and standardized equipment.
To support your enrollment goals, we employ dedicated patient enrollment specialists, develop clear patient education materials, and collaborate with Patient Advocacy Groups (PAGs) to reduce burden. Our patient-centric approach means fewer clinic visits and flexible screening. This way, patients are supported at every step, and your study stays on track.
COPD Clinical Trial Expertise
Successful trial delivery in COPD starts with selecting the right countries and sites. SYNETIC™, PSI’s first-of-its-kind semantic knowledge platform for smarter site ID and selection, connects data from more than 500,000 institutions, 3 million study sites, and 300,000 clinical projects to analyze each site’s performance and the current competitive landscape, providing a verified data-driven site list in minutes.
Beyond pragmatic site selection, COPD trials require thorough start-up preparation and proactive mitigations to support older, more fragile patient populations. PSI’s specialized Site Support team works closely with our CRAs to support patients and investigators with tailored enrollment strategies at each site, including reviewing patient databases, confirming treatment standards, coordinating enrollment timing, and preparing for pre-screening to ensure trials stay on target over lengthy study durations.
Asthma Clinical Trial Expertise: Adults and Pediatric
Asthma clinical trials are increasingly complex, with over 40 novel therapies – including anti-TSLPs, bispecifics, and multi-target agents – currently advancing through the pipeline. PSI’s feasibility team translates real-time market intelligence into practical site and country strategies, supported by a network of high-performing centers with experience in advanced asthma therapeutics, digital health integration, and complex phenotyping. In both adult and pediatric populations, our tailored support helps each site maximize enrollment potential, including navigating age-specific considerations such as recruitment, consent, and endpoint selection, even in highly competitive settings.
Pneumonia Clinical Trial Expertise
PSI’s team delivers pivotal pneumonia trials faster than the industry, having supported numerous global studies in both community- and hospital-acquired indications. Our deep expertise in infectious respiratory diseases spans adult and pediatric populations. We support high-risk patients and caregivers by alleviating burden and maximizing retention, using the PSI Participant Pathway™ to visualize each site’s study journey.
PSI stands apart through our comprehensive microbiology strategy and hands-on management of both local and regional laboratories. For large pneumonia trials, we recommend using engaged regional labs for key tasks such as quantitative culture and susceptibility testing. Our Lab Support team provides direct, face-to-face training and close oversight to deliver harmonized, high-quality data and reliable regulatory outcomes for your program.
PSI Respiratory Highlights
Real results: PSI sponsors’ respiratory clinical trial success stories
Specialized Respiratory Trial Support Services
Spirometry: Standardizing the Measurement that Shapes Your Study
High-quality spirometry data is a vital pulmonary endpoint for demonstrating efficacy in pivotal respiratory studies, yet achieving consistent, reliable data across sites remains a challenge. Variability in spirometry data quality across sites can pose risks and impact trial outcomes, particularly as digital technologies and decentralized elements become increasingly common.
PSI minimizes this risk by implementing rigorous site qualification, standardized equipment and processes, and continuous data oversight:
- Site and site team experience: Evaluation of each site’s certification, training history, clinical trial experience, and familiarity with ATS/ERS guidelines; previous quality metrics from other studies are a good guide, but it’s vital to ensure the same staff will perform the spirometry
- Training: Including both initial and ongoing training, with recorded refresher sessions for easy access and immediate, targeted one-on-one training for any lapses
- Standardization: Using standardized devices and processes at all sites to minimize variation
PSI’s Medical Monitoring Team provides tailored spirometry training at the start of the study, reinforced with ongoing, targeted refreshers and real-time quality monitoring, to ensure consistent quality and regulatory confidence throughout your trial.
Mapping the Participant Journey for Complex Respiratory Trials
Respiratory studies often struggle with high dropout rates due to technical difficulties or burden. The PSI Participant Pathway™ addresses this persistent challenge by providing a visual map of the patient’s journey through the trial, from eligibility screening through follow-up, customized to each site’s operations. The Participant Pathway™ equips site teams to anticipate and overcome logistical challenges and serves as a mock patient to proactively avoid safety or deviation issues.
This guide supports:
- Training for key protocol components: Prepare site staff for dosing and any procedures required in the study design
- Anticipating referral opportunities: Guide sites in leveraging existing patient flow and referral structures to maximize eligible patient identification for the trial
- Operational planning for high visit frequency: Help sites plan for each step of the logistical requirements, ensuring both patients and staff can manage and adhere to the trial’s complex schedule
- Continuous oversight and adaptation: Equip sites with decision-support resources and direct access to respiratory experts to proactively resolve scheduling and adherence issues, supporting high-quality, compliant trial execution
Get in touch with PSI’s respiratory team
See why sponsors call working with PSI “a breath of fresh air.” Connect with our team of experts today.
Trusted to Deliver
When you partner with PSI, you work with a team recognized by independent industry organizations and sponsor surveys for what matters most in clinical research: expertise, consistent operational excellence, and reliable delivery.
