The early phase clinical contract research organization (CRO) received the certification at its Algorithme Pharma USA facility in Fargo, North Dakota. It is the company’s third site to be certified.
The iCardiac/ERT technology platform enables researchers to conduct first-in-human studies using early cardiac monitoring to provide cardiac analysis, which could eliminate the need to conduct a stand-alone Thorough QT (TQT) study near the end of Phase II or early Phase III.
“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,” said Ingrid Holmes, vice president of clinical operations at Altasciences.
“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,” she told us. “Sponsors could potentially de-risk early development programs and increase the valuation of a product for out-licensing.”
Certification
To become certified in the technology, Holmes said there are a number of steps to fulfill at the site level.
“We need to demonstrate that we have qualified and competent staff who can produce consistent, high quality data,” she told us.
Additionally, each site needs to identify two “champions” to complete the training program and perform mock study data collection as part of their evaluation.
Holmes explained the site champions are responsible for overseeing the program, ensuring that training is performed according to standards, and that studies are conducted appropriately.
“With this certification, our clients can be assured that the critical nature of their study’s cardiac data collection is well understood, and that the site has shown its ability to produce data of the highest quality,” she added.