Respiratory Disease CRO
According to the Forum of International Respiratory Societies, hundreds of millions of people suffer from respiratory diseases each year. Consistent with this high prevalence rate, respiratory disease remains a uniquely important, but complex field of clinical research, encompassing a wide range of illnesses which vary widely in terms of biological processes, severity, and efficacy of treatment options.
In order to successfully undertake a product development program within this therapeutic domain, it is crucial to select a CRO that recognizes the ingrained complexities of respiratory disease research.
At ethica CRO, our prior experience lies within the following, non-exhaustive list of respiratory conditions:
Asthma is the most common chronic disease among children.
Cystic fibrosis is the most common, fatal genetic disease in North America.
Chronic obstructive pulmonary disease (COPD)
COPD is the third leading cause of death worldwide.
Learn more about how working with us can benefit your respiratory disease study.
Our Respiratory Clinical Trial Experience
While our study management team is prepared to help you efficiently conduct your respiratory clinical trials, we are also committed to mitigating risks and reducing study-related costs.
Since its inception, ethica CRO has completed over 18 respiratory disease studies. The graphic below demonstrates the percentage of studies per indication undertaken by our clinical management team.
Your CRO of Choice for Respiratory Disease Research
Our team will help you:
- Manage research participant screening and education;
- Propose a methodology adapted to the reality of the targeted research population;
- Promote compliance and retention, especially when dealing with a younger demographic.
Case Study – How ethica CRO helped its client navigate technical and regulatory challenges, leading to the approval of dry powder mannitol for the treatment of cystic fibrosis
Cystic fibrosis (CF) is among the most prevalent respiratory diseases in the world. CF affects 1 in every 3600 Canadian children, making it the most common fatal genetic disease in Canada. There is currently no cure for CF, but there exist treatment options that have been shown to improve the symptoms and quality of life of people living with this debilitating disease.
Inhaled mannitol is a relatively new medication that helps facilitate mucociliary clearance in CF patients. After this drug passed through its initial clinical trial phase, an Australian biotechnology company and manufacturer of inhaled mannitol selected ethica CRO to conduct the Phase II and III clinical trial portions of their research programs to assess the safety and efficacy of inhaled mannitol for the treatment of CF and bronchiectasis.
Our clinical management personnel oversaw site management, recruitment, and monitoring, as well as eCRF data query resolutions for over 50 sites located across North America. After successfully navigating some major technical and regulatory challenges and whilst ensuring participant safety, ethica CRO proceeded to effectively design and manage the Phase II and Phase III trials that later led to the drug’s approval for the treatment of CF in 12 countries including, most recently, the United States.
Importantly, the study Sponsor for these series of studies was so pleased with the quality and performance of ethica CRO’s clinical team that they further engaged our CRO services by performing a rescue of a concurrent study being managed by a major US-based CRO.