Altasciences Expands its Purpose-Built Inhalation Testing Facilities
Laval, Quebec, May 1, 2019– Altasciences announced today that they have completed the expansion of their specialized smoking/vaping facility across their clinical research units in North America, demonstrating their commitment to further assisting sponsors in meeting the requirements for regulatory submission for inhalation products.
Altasciences’ purpose-built, indoor facilities include a total of 23 highly specialized procedure rooms where multiple studies can be conducted simultaneously. The facilities are divided into areas with systems controlling negative pressure, independent ventilation air cleaning, contamination and participant observation, to allow for the evaluation of tobacco, electronic nicotine delivery systems (ENDS), including cannabis, covering study types such as human abuse potential, smoking cessation, ENDS risk assessment, pharmacokinetics and pharmacodynamics, as well as pharmaceuticals.
“Our experience with both the pharmaceutical and device industries, coupled with our innovative facilities and expert staff, ensure that Altasciences is uniquely qualified to conduct these specialized clinical trials,” said Ingrid Holmes, Vice President, Global Clinical Operations at Altasciences.
Furthermore, to support their clinical operations, Altasciences has been investing heavily in developing the robust list of validated biomarkers with the sensitivity required for inhalation products, including tobacco.
“Our bioanalytical lab has been analyzing pharmacokinetics of products delivered by inhalation, such as nicotine or cannabis, in blood and urine, for years, and we offer top-grade, validated bioanalytical methods for the analysis of biomarkers of exposure and of potential harm,” explained Holmes.
Altasciences is a forward-thinking, mid-size contract research organization offering pharmaceutical and biotechnology companies a proven, flexible approach to preclinical and clinical pharmacology studies, including formulation, manufacturing, and analytical services. For over 25 years, Altasciences has been partnering with sponsors to help support educated, faster, and more complete early drug development decisions. Altasciences’ integrated, full-service solutions include preclinical safety testing, clinical pharmacology and proof of concept, bioanalysis, program management, medical writing, biostatistics, and data management, all customizable to specific sponsor requirements. Altasciences helps sponsors get better drugs to the people who need them, faster.
Our deep expertise and capabilities in a broad range of therapeutic areas encompasses preclinical and early clinical studies for both small molecules and biologics. We can manage your entire program, as well as provide comprehensive support research services and bioanalytical expertise.
Please see Therapeutic Areas for a fuller discussion of our capabilities and expertise.