An allergy CRO with the expertise you need
Unprecedented advances in allergy treatments – including traditional therapeutics, innovative biologics, novel immunotherapies, and optimized routes of administration – are bringing heartening news to those affected and creating exciting opportunities for drug developers. Conducting successful clinical trials, however, requires a deep understanding of best practices for each of these complex indications and their wide-ranging symptoms and causality.
For example, allergic rhinitis is typically impacted by regional differences and seasonal environments, thereby involving specialized vendors, high-touch clinical support for sites, and risk mitigation strategies. Food allergy trials often require complex challenge procedures and rigorous safety monitoring, making early planning and site training essential for successful execution. In every case, a patient-centered approach is key to recruitment, retention, and compliance.
Our approach
At Parexel, our best practices have developed over many years of conducting clinical trials in this challenging therapeutic area. Led by a board-certified allergist-immunologist, our dedicated therapeutic area team with focused experience in allergic conditions plays an essential role on the entire path to approval, beginning with study startup – the crucial initial planning process. We have extensive experience conducting allergy and immunology trials in both pediatric and adult populations, tailoring study designs and operational strategies to meet the unique needs of each age group. We have executed studies across the spectrum of allergic diseases and immunodeficiencies including allergic rhinitis/rhino conjunctivitis, chronic rhinosinusitis with nasal polyps, food allergy, asthma, atopic dermatitis, urticaria, primary immunodeficiency, hereditary angioedema, and more.
We have specialized relationships with sites equipped with environmental exposure chamber capabilities for controlled allergen-exposure studies. Our experience ranges from Early Phase trials conducted in our own Early Phase Clinical Units to complex global trials in Phases II-IV.