Respiratory Services

Respiratory clinical research requires a broad range of experience, multidisciplinary support and resources. As an international mid-size CRO, supporting bio/pharma clients in Europe and North America, we are recognized as the benchmark clinical research partner for quality, reliability, flexibility and customer care. Our comprehensive early and late phase expertise in pulmonary diseases, includes asthma, COPD, rhinitis, bronchiolitis and cystic fibrosis.

Why choose respiratory clinical research services from SGS?

Benefit from our extensive experience

Our dedicated therapeutic project director provides over 30 years of experience in clinical research, and applies his expertise to your project, defining the best scientific approach for compound development, study design, execution, analysis and reporting. The project director is fully supported by a complete team of clinical and biometrics staff with therapeutic respiratory disease backgrounds.

We have conducted over 40 respiratory clinical trials in the past five years, including 17 multi-center clinical trials in respiratory and pulmonary diseases (Phase II/III) in the following Indications:

• Allergic rhinitis
• Asthma
• Bronchiolitis Obliterans Syndrome (BOS)
• Chronic Obstructive Pulmonary Disease (COPD)
• Cystic fibrosis
• Cystic fibrosis (with Pseudomonas aeruginosa infection)
• Perinatal asphyxia
• Pulmonary Arterial Hypertension

Rely on our solid respiratory clinical research expertise

With unique expertise in respiratory indications, we have specifically developed inhalation studies for asthma and COPD, including:

• All classic pathways using LABA, LAMA, ICS, LTB4 + PDE4 inhibitors, mast cell stabilizers and methylxanthines
• New therapies under investigation, such as CRTH2 inhibitors and Monoclonal Ab, involving the TLR3 target
• Pharmacodynamic methods to address respiratory diseases, such as spirometry, whole body plethysmography, airway resistance, FeNO, arterial blood gases, and continuous monitoring EtCO2, sputum induction and bronchoaleolar lavage

Enroll the right patients for your trials

With our network of clinical sites, we offer you efficient patient enrollment. Our exclusive patient center and hospital partnerships, using on-site KOLs and SGS-experienced medical staff, all work with our robust and proven quality systems.

A Range of World-Leading Respiratory Clinical Research Services

From stand-alone support to a complete service package, our range of services include:

• Consultancy services: from reviewing preclinical and clinical data to regulatory services for Investigational Medicinal Product Dossiers (IMPD) and regulatory submission strategy input
• Clinical development planning: including target profile, product positioning, and Phase I design and synopsis
• Phase I-IV clinical trials
• Biometrics services: we provide data management, PK/PD analysis, statistics, medical writing and high-quality data for health authorities (including FDA and EMEA)
• Pharmacovigilance: we can help you with drug safety and post-registration regulatory affairs
• Bioanalytical laboratory services: we offer dedicated bioanalytical labs for inflammatory parameters, biomarkers (such as cellular, serum and sputum/BALF), respiratory parameters (such as hs-CRP), flow cytometry for inflammatory cells (neutrophils, eosinophils, fibrocytes) and inflammatory cytokines (TNF-a, IL-1b, IL-6, IL-8, IL-10)

For expert feedback on your respiratory drug development program, contact us today.