Altasciences certified in early QT assessment tech

By Melissa Fassbender

- Last updated on GMT

(Image: Getty/Natali_Mis)
(Image: Getty/Natali_Mis)
Altasciences Clinical Research has received iCardiac/ERT certification, which the CRO says assures clients that the critical nature of their study’s cardiac data collection is well understood.

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.”


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.

Related news

Related products

show more

Saama accelerates data review processes

Saama accelerates data review processes

Content provided by Saama | 25-Mar-2024 | Infographic

In this new infographic, learn how Saama accelerates data review processes. Only Saama has AI/ML models trained for life sciences on over 300 million data...

More Data, More Insights, More Progress

More Data, More Insights, More Progress

Content provided by Saama | 04-Mar-2024 | Case Study

The sponsor’s clinical development team needed a flexible solution to quickly visualize patient and site data in a single location

Using Define-XML to build more efficient studies

Using Define-XML to build more efficient studies

Content provided by Formedix | 14-Nov-2023 | White Paper

It is commonly thought that Define-XML is simply a dataset descriptor: a way to document what datasets look like, including the names and labels of datasets...

Related suppliers

Follow us