OVERLAND PARK, Kan.--(EON: Enhanced Online News)--Vince & Associates Clinical Research, an Altasciences company, announced today the opening of a controlled ventilation indoor vaping room at their clinical research unit in Overland Park, Kansas.
“Our purpose-built smoking facilities represent our commitment to assisting our sponsors in meeting the new requirements for FDA submission”
The vaping room’s ventilation system is designed to provide multiple air changes per hour, with a gas and particulate removal device to maintain a negative pressure environment. The vaping room is a complement to Vince & Associates’ purpose-built smoking evaluation facility for clinical studies for e-cigarette and vaping products, including the human laboratory model of smoking behavior. The state-of-the-art facility ensures sponsors are able to meet the new requirements for FDA submissions following regulations that went into effect in May 2016.
Sponsors wanting to market tobacco products that were not on the market as of February 15, 2007, including all e-cigarette and vaping products, will now need to conduct research to include as part of their FDA submission. The FDA states “The tobacco product review process gives the agency the ability to evaluate important factors, such as ingredients, product design and health risks, as well as their appeal to youth and non-users.”
Clinical studies may be required to examine the potential for new product initiation or cessation using traditional combustible cigarettes and e-cigarettes. Study volunteers will be asked to respond to a series of questions that provide valuable data regarding changes in tobacco use behavior (including Abuse Potential).
With its purpose-built facility and industry leading experience in human abuse potential/likeability, Vince & Associates is well positioned to conduct trials that provide the most complete data for FDA submissions.
“Our purpose-built smoking facilities represent our commitment to assisting our sponsors in meeting the new requirements for FDA submission,” said Dr. Brad Vince, CEO and Medical Director at Vince & Associates, an Altasciences company.
Altasciences’ customizable full-service model allows clients to choose any or all support services to support these trials, from protocol writing all the way through to clinical study report writing. Our leading bioanalytical laboratory team has extensive expertise with validated assays for nicotine (including metabolites) in plasma and urine.
Altasciences Clinical Research encompasses Algorithme Pharma in Montreal, QC, Vince & Associates Clinical Research in Overland Park, KS, as well as Algorithme Pharma USA in Fargo, ND, thereby making it one of the largest early phase clinical CROs in North America. With over 25 years of industry experience, Altasciences provides early phase clinical development services to an international customer base of biopharmaceutical and generic companies. Altasciences’ full service solutions offering in this critical stage of drug development includes medical writing, biostatistics, data management and bioanalysis.
Vince & Associates operates a state-of-the-art, clinical pharmacology unit that combines the ultimate in subject safety and luxury. This early development unit has the upscale atmosphere necessary for the recruitment and retention of study volunteers in both short- and long-term clinical trials.