A respiratory CRO with the expertise you need
From the millions of individuals affected by asthma and COPD to the few affected by rare diseases, bringing innovation and more affordable treatments to patients is our passion as a respiratory CRO.
Through partnerships with the leading pharma companies and biotech innovators, we collaborate across the full ecosystem of respiratory disease research. As a single point of contact, we integrate meaningful data to assess treatment efficacy in an interventional trial and relevant insights in the real world of respiratory disease.
Chronic obstructive pulmonary disease (COPD)
Despite the prevalence of COPD and its severe effects on quality of life, few new therapies have been approved for more than a decade. COPD exacerbations have a considerable impact on health care costs and mortality rates, and nearly 20% of patients hospitalized for an initial COPD exacerbation time die within a year. For patients with limited treatment options, however, there is reason to hope as drug developers pursue new avenues.
What are Challenges in COPD Clinical Research?
Sponsors face challenges on several fronts:
- Hundreds of COPD clinical research studies are underway, resulting in strong competition for trial participants.
- Patient populations have historically been underrepresented, particularly in the U.S., with large gaps in certain at-risk communities.
- Mistrust of the medical field – the most frequently cited obstacle to participation – is a major issue in recruiting the full spectrum of patient demographics.
- Financial burden, compounded by concerns about job absences, transportation expenses, childcare, and the like.
Parexel’s Advantage with Respiratory CROs
These challenges can be overcome with the right approach. In a recent program of three trials for COPD treatment, for example, Parexel completed the project three months ahead of schedule and 10% under budget. In fact, Parexel is uniquely qualified to support research in COPD, both as a recognized industry leader in respiratory diseases and specifically in patient education and recruitment – critical components for running these trials. An essential element of our approach involves patient advocacy groups, which play an important role in connecting patients with researchers and breaking down barriers. We maintain close, trusted relationships with groups focusing on COPD to understand the patient’s voice and inform protocol design. Parexel’s commitment to this therapeutic area has attracted an outstanding team of top physicians who are devoted to finding treatments for COPD.
Asthma
Asthma is one of the most common chronic respiratory conditions worldwide, affecting nearly 300 million individuals of all ages. It is a process characterized by airway inflammation and narrowing, which results in individuals experiencing a myriad of symptoms including shortness of breath, coughing, wheezing, chest tightness and decreased exercise tolerance. In 2023 nearly 500,000 fatalities were attributable to asthma. It can range from mild to severe and is often triggered by allergens, exercise, cold air, or stress.
The burden of asthma extends beyond individual health—it impacts healthcare systems, workplaces, and economies due to emergency visits, hospitalizations, and missed work or school days. Effective management includes patient education, access to medications like inhalers, early symptom recognition, and avoiding environmental triggers such as allergens or pollutants.
Managing asthma has classically involved avoiding triggers, using controller inhaler medication like corticosteroids for control and rescue inhalers as needed for symptom management. Recently there has been rapid advancement within the asthma space with the introduction of highly effective newer biologic therapies that target a variety of cytokines.
Despite these changes there is a persistent unmet need for access to highly effective therapies for most asthmatics.
Experience in the past 5 years
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asthma and COPD projects
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patients enrolled
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global sites
Our experts
Frequently Asked Questions
A respiratory Contract Research Organization (CRO) is a specialized service provider that supports pharmaceutical, biotechnology, and medical device companies in conducting clinical trials and research specifically focused on respiratory conditions and diseases.
These CROs have expertise in respiratory therapeutic areas such as asthma, chronic obstructive pulmonary disease (COPD), cystic fibrosis, pulmonary fibrosis, respiratory infections, and sleep apnea. They offer services including protocol development, patient recruitment, site selection, regulatory submissions, data management, biostatistics, medical monitoring, and pharmacovigilance—all tailored to the unique challenges of respiratory research.
Respiratory CROs employ specialists who understand the complexities of respiratory endpoints, pulmonary function testing, imaging techniques, and biomarkers specific to respiratory conditions. They have experience with specialized equipment like spirometers, plethysmographs, and other pulmonary function testing devices.
These organizations often maintain networks of investigators and sites with expertise in respiratory medicine, allowing for more efficient patient recruitment and high-quality data collection. By partnering with a specialized respiratory CRO, sponsors can benefit from focused expertise that may lead to more efficient trials, better quality data, and ultimately faster development of respiratory therapies.
Respiratory CROs offer a comprehensive suite of services tailored specifically to respiratory clinical trials. These typically include protocol development with respiratory-specific endpoints and assessments, patient recruitment strategies for respiratory conditions, and site selection focusing on centers with pulmonary expertise. They provide specialized training for clinical staff on respiratory assessments such as spirometry, plethysmography, and other pulmonary function tests to ensure standardized, high-quality data collection.
Respiratory CROs also offer medical monitoring by pulmonologists, respiratory data management, biostatistical analysis of complex respiratory endpoints, and regulatory affairs support for submissions to health authorities. Additionally, they provide pharmacovigilance services with particular attention to respiratory adverse events and specialized laboratory services for handling respiratory specimens and biomarkers.
Beyond these core services, respiratory CROs often provide specialized respiratory imaging services including chest X-rays, CT scans, and innovative imaging techniques specific to lung diseases. They frequently incorporate patient-reported outcome measures relevant to respiratory symptoms and quality of life and may offer home health services for patients with limited mobility due to respiratory conditions.
Many respiratory CROs have expertise in medical device trials for inhalers, nebulizers, and other respiratory delivery systems, as well as experience with adaptive trial designs that are increasingly common in respiratory research. Some also provide post-marketing surveillance and real-world evidence generation for respiratory products, along with health economics and outcomes research to demonstrate the value of respiratory interventions to payers and health systems.
Parexel provides comprehensive CRO services across a broad spectrum of respiratory conditions, leveraging its extensive global experience and therapeutic expertise. The company supports clinical trials and research in major respiratory diseases including asthma, chronic obstructive pulmonary disease (COPD), cystic fibrosis, idiopathic pulmonary fibrosis (IPF), pulmonary arterial hypertension, respiratory infections (including pneumonia, influenza, RSV, and COVID-19), allergic rhinitis, and sleep-related breathing disorders.
Parexel's respiratory expertise extends to both adult and pediatric populations, covering the full range of disease severity from mild to severe and life-threatening conditions. The organization has experience with various treatment modalities including small molecules, biologics, inhalation devices, and combination products specific to respiratory indications.
Parexel's respiratory services are supported by specialized teams with deep understanding of the unique challenges in respiratory research, including complex endpoint assessments, biomarker development, and regulatory pathways. The company offers tailored solutions for patient recruitment in respiratory trials, which can be challenging due to seasonal variations, comorbidities, and the need for specific pulmonary function parameters.
Parexel's global site network includes investigators and centers with specific respiratory expertise, ensuring high-quality data collection for specialized assessments such as spirometry, body plethysmography, diffusion capacity testing, and respiratory imaging. Additionally, Parexel provides expertise in patient-reported outcomes specific to respiratory symptoms and quality of life, which are increasingly important components of respiratory drug development programs and regulatory submissions.
Parexel provides comprehensive regulatory support for respiratory clinical trials, leveraging its deep expertise in global regulatory requirements specific to respiratory drug and device development. The company's regulatory services include strategic consulting on regulatory pathways for respiratory products, preparation and submission of regulatory documents such as Investigational New Drug (IND) applications and Clinical Trial Applications (CTAs), and management of interactions with regulatory authorities worldwide.
Parexel's regulatory experts are well-versed in the specific requirements for respiratory products, including the FDA's guidance on developing drugs for specific respiratory conditions, the EMA's requirements for respiratory medicines, and similar guidelines from other regulatory bodies globally. They provide strategic input on clinical trial design to ensure alignment with regulatory expectations, including appropriate endpoint selection, patient population definitions, and statistical considerations specific to respiratory indications.
Additionally, Parexel offers specialized regulatory support for respiratory devices and combination products, which are common in this therapeutic area. This includes navigating the complex regulatory landscape for inhalers, nebulizers, and other drug delivery systems, as well as digital health technologies increasingly used in respiratory care. The company's regulatory teams provide guidance on device-specific requirements, human factors studies, and the coordination of drug and device regulatory submissions.
Parexel also supports post-approval regulatory activities for respiratory products, including label expansions, pediatric investigation plans, and post-marketing commitments. With expertise in both established and emerging markets, Parexel helps clients develop global regulatory strategies that account for regional differences in requirements for respiratory products, ultimately facilitating more efficient development and commercialization pathways for these specialized therapies.