LAVAL, QC, Canada (June 1, 2016) — Altasciences Clinical Research announced today that its clinical facility, Algorithme Pharma, in Montreal, Canada, has received its iCardiac Certification. In January 2015, Altasciences’ Overland Park site, Vince & Associates Clinical Research, became the first clinical research provider in the world to be iCardiac certified. High-precision technology is opening a new era where QT analysis can be conducted in earlier, first-in-human studies – before sponsors commit to further development work.
“We are excited that early QT assessment is now being seen as an accepted alternative to a TQT study. TQT study waivers are already being granted. Our ability to conduct both traditional TQT studies as well as High Precision QT analysis in early phase trials means that we can obtain the highest quality ECG data and potentially eliminate the need for a full TQT study. Sponsors could potentially de-risk early development programs and increase the valuation of a product for out-licensing,” said Ingrid Holmes, Vice President, Clinical Operations.
iCardiac’s innovative technology platform allows for the highly powered assessment of first-in-human studies utilizing early cardiac monitoring to provide statistically powered cardiac analysis, potentially alleviating the requirement for a thorough QTc (TQT) study. As qualified partners, Altasciences’ certified sites and iCardiac will 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.
“We are proud to provide the best quality early stage clinical development services to our pharmaceutical, biotechnology and generic sponsors, with a multi-site solution to increasingly complex early stage clinical drug development needs. This certification to conduct trials using iCardiac Early Precision QT demonstrates our drive to focus on offering state-of-the-art services to our clients,” said Chris Perkin, CEO, Altasciences Clinical Research.
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.
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