LAVAL, Quebec--(BUSINESS WIRE)--Altasciences Clinical Research announced today that its third clinical facility, Algorithme Pharma USA, in Fargo, North Dakota, has received its iCardiac/ERT Certification.
Altasciences’ experience using High Precision QT analysis allows us to perform thorough QT (TQT) prolongation studies with a smaller number of participants due to the reduced variability using the iCardiac/ERT technique. Also, Altasciences offers High Precision QT analysis to assess QT prolongation in early phase clinical trials, such as first-in-human. This allows sponsors to potentially receive a waiver to not have to perform a TQT study later in their drug development program, thus saving considerable time and money.
“As a CRO focused on early phase clinical development, we have the facilities and the qualified medical personnel to run both simple and complex trials. We are pleased that all three of our clinical sites are now iCardiac/ERT certified, which is in line with our global strategy to continuously take our solution offering to the next level,” said Chris Ore, General Manager, U.S. Clinical Operations, at Altasciences.
As qualified partners, Altasciences’ sites and iCardiac/ERT work together to provide biopharmaceutical clients with recommendations concerning the design, conduct, analysis and interpretation of continuous Holter recordings to assess the cardiac safety profile of a drug during the conduct of a Phase I study.
In January 2015, Altasciences’ Overland Park site, Vince & Associates Clinical Research, became the first clinical research provider in the world to be iCardiac certified, followed by its sister site, Algorithme Pharma, in Montreal, Quebec, in June 2016.
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.