OVERLAND PARK, Kan.--(BUSINESS WIRE)--Vince & Associates Clinical Research, an Altasciences company, announced today the opening of their new four-story building as a part of their early phase clinical research campus expansion, which includes a QT safety assessment unit, a controlled ventilation smoking area, a limited access specialty unit, as well as an expanded pharmacy and recruitment center.
The new building’s QT safety assessment unit has been specially designed to minimize 60hz cardiac monitoring interference and allow for enhanced data collection. The unit has been engineered for traditional ECG collection as well as Holter monitoring.
“This cutting-edge QT safety assessment unit positions us to support the new ICH E14 Guideline: The Clinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential for Non-Antiarrhythmic Drugs and allows us to obtain the highest quality ECG data and potentially eliminate the need for a full TQT study,” said Dr. Brad Vince, CEO and Medical Director at Vince & Associates.
The building will also house two highly specialized units for complex clinical trials. The first is a controlled ventilation smoking area distinctly divided into two zones with independent ventilation systems to allow for the evaluation of smoking cessation, smoking, vaping, tobacco risk assessment and nicotine delivery. This smoking area will support studies that will be required under the new FDA regulations for all tobacco products. The second is a secure, limited access specialty unit to sequester unique populations in early phase studies.
Our state-of-the-art pharmacy includes an expanded USP 797 certified clean room that exceeds industry standards by maintaining an ISO Class V environment. Additionally, it includes a standalone HVAC system for temperature and humidity control, an isolated negative pressure extemporaneous preparation room with analytical and micro-analytical balances, additional area for storage and investigational product preparation and multiple layers of security access including facial recognition.
Our new recruitment center will support Vince & Associates’ unparalleled recruitment rates for both special population and healthy normal volunteer clinical trials. This recruitment center will support the increasingly complex demand for qualified study volunteers.
“This new four-story expansion represents a culmination of more than three years of planning and incorporating feedback from our clients and the pharma Industry. In the end, we have created solutions for a 21st-century clinical pharmacology unit that not only addresses the needs of our study volunteers but the ever increasing expectations from our biopharmaceutical clients,” explained Dr. Vince.
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 currently 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.