Biomedical Systems offers Sponsors
centralized data acquisition, analysis
and management for Challenge Testing
for pharmaceutical and medical device
clinical trials.
The Process
Statistically, Challenge Testing has proven to be the most effective method to separate asthmatics from non-asthmatics.
During inhalation testing, patient volunteers are introduced to increasing amounts of an allergen inhaled through a nebulizer, a device that uses a face mask or mouthpiece to deliver the allergen in a fine mist (aerosol). Alternatively, increasing amounts of a substance (methacholine) may be inhaled through the nebulizer. Before and after inhaling the substance, spirometry readings are taken to evaluate lung function.
Biomedical Systems Complete Challenge System
Biomedical Systems supplies the clinical site with standardized Spirometry/Challenge Software (Methacholine Software or Mannitol Software), a dosimeter and protocol specific customized provocholine kits.