We’ve conducted more than 300 respiratory disease trials, from the most common indications as COPD (30+ studies), Rhino sinusitis (20+ studies), and ASTHMA through rare indications such as a1-Anti trypsin deficiency, Pulmonary Fibrosis, and Cystic Fibrosis (25+ studies conducted)
The increased prevalence of allergy and respiratory illnesses in the past 20 years has been met with a corresponding surge in clinical research. PRA has participated in the development of allergy and respiratory drugs on the market today, as well as in several inhalers for respiratory products, providing clinical, operational, and consultative support for respiratory research, from pre-clinical stage up to post registration.
We understand the complexity of respiratory research, which is why we have built a global ecosystem of capabilities and relationships required to successfully navigate this landscape. This ecosystem is guided by our in-depth respiratory expertise and experience, empowering you with effective and efficient solutions across every facet of respiratory research from trial to treatment. As several areas and indications in the respiratory field require a multidisciplinary approach, PRA has developed an extensive internal collaborative environment. By grouping infectious disease, pediatrics, rare disease, device development, innovation technology, translational, regulatory, and real world solution experts to work together on the strategies and deliveries, a comprehensive approach minimizes gaps faced during the asset development process. As PRA has experience working with all companies from large Pharma to small biotechs, we appreciate the specific challenges faced by our clients and are prepared to address any potential need during successful drug development.
Respiratory drug development is no easy task, but our team of board-certified pulmonologists and recognized experts in pulmonary function testing is up for the challenge. We’ve established committee memberships and fellowships with several major professional societies, including the American Thoracic Society, European Respiratory Society, American College of Chest Physicians, and American Association for Respiratory Care, as well as relationships with other investigators and leaders in respiratory clinical research.
We specialize in the standardization of key respiratory assessments, and our expertise covers a wide range of indications, such as:
- Allergic and non-allergic Rhinitis
- Chronic Obstructive Pulmonary Disease (COPD)
- a1-Anti trypsin deficiency
- Respiratory infections (Pneumonia, Adenovis, RSV, Influenza, COVID-19, tuberculosis)
- Cystic Fibrosis
- Pulmonary Fibrosis
- Pulmonary hypertension
- ARDS/SEPSIS and critically ill (ICU trials)
- Sleep disorders
Our respiratory trial experience includes incorporating several respiratory testing methods and their implementation at a site or with a patient, such as:
- Functional tests (Spirometry, Lung Volumes, DLCO, Cardio Pulmonary Exercise Test (CPET), 6 minutes walking test (6MWT))
- Imaging (Radiography, HRCT, RNM, Volumetric CT)
- Nuclear medicine (Lung Scintigraphy, Quantitative Lung function, V/Q Scintigraphy)
- Self-assessed Scores and Patient Reported Outcome (PRO) Questionnaires (including electronic format)
- Wearables (actigraphy, pressure insoles, telemedicine, respiratory monitoring)
- Ventilators (For invasive mechanical ventilation as well as non-invasive devices as CPAP and BI-PAP)
- Oxygen therapy (Low and High flow oxygen therapy)
The therapeutic combat against the COVID-19 pandemic has turned into the largest collaborative global effort in the modern history of clinical development. PRA’s technology and mobile health capabilities have played a big role, helping enroll and monitor over 30,000 patients worldwide in COVID-19 clinical trials.Read more about our COVID-19 experience
Innovative Solutions Improving Patient Experience
From our experience in clinical trial conduct during pandemics, rare diseases, and in environments with different kinds of restrictions, we believe it is essential to reduce patient burden by properly understanding the patient’s pathway from home to site in all countries in which we conduct clinical trials. We must understand how much the disease may be affecting a patient’s life and try to fit our studies with innovative solutions that facilitate patients and improve study compliance. That is why we explore different approaches, such as facilitating site access, implementing mobile health technology, simplifying study design, optimizing site visits, and preparing patient facing materials that are clear and complete. As feasibility permits, the goal is to bring site procedures and assessments to the patient’s home for convenience.
In Touch with Patient Communities
As patient experience, wellbeing, and safety are quite important to us, we have also established relationships with disease-specific patient societies such as cystic fibrosis and pulmonary fibrosis organizations.Learn more about our Rare Disease expertise
We’ve contributed to the successful approval of eight marketed cardiovascular and cardio-metabolic drugs.
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