Icon updates MIRA in response to FDA guidance

By Nick Taylor

- Last updated on GMT

Related tags: Myocardial infarction

Icon has brought its operations in line with new FDA guidelines by implementing an electronic system to accelerate the adjudication of cardiovascular events in diabetes trials.

The guidance by the US Food and Drug Administration (FDA) was issued in December and recommended an independent cardiovascular endpoints committee was established for Phase II, III and some IV diabetes trials.

Icon has done this and implemented an electronic system building on its MIRA (Medical Imaging Review and Analysis) technology platform to reduce the inefficiencies that are inherent when these committees rely on paper.

Jonathan Goldman, chief medical officer at ICON Medical Imaging, said: “ICON’s electronic adjudication solution provides the most secure and accurate method of defining true cardiovascular events in real-time​.

Because of its inherent regulatory compliance it is ideally suited to comply with the recent FDA guidelines for diabetes trials. It also provides significant savings in costs and timelines by preventing unnecessary enrolment of patients once the target number of endpoints has been achieved​.”

The committees are being set up to adjudicate cardiovascular events, including cardiac death, acute myocardial infarction and stroke, in clinical trials of diabetes drugs.

Icon’s MIRA system will store information that could be relevant to adjudicating cardiovascular events. This includes case report forms, patient charts, laboratory results, echocardiogram, coronary angiogram, peripheral angiogram and x-rays.

Information contained within the system will be accessible remotely, enabling committee members to access and review the data from different locations.

Related news

Show more

Related products

show more

How clinical trial software can optimize trials

How clinical trial software can optimize trials

Formedix | 09-Jun-2021 | Technical / White Paper

This article explains the different types of clinical trial software available, and how it can be used to optimize the end to end clinical trials design...

Adapting supply chains to new ways of working

Adapting supply chains to new ways of working

World Courier | 01-Jun-2021 | Technical / White Paper

COVID-19 has changed the way we operate. We have adapted our supply chain solutions to meet our clients’ requirements while following World Courier standard...

What are the building blocks of DCTs?

What are the building blocks of DCTs?

Medable | 26-Apr-2021 | Technical / White Paper

How to create a seamless experience across eConsent, eCOA and more.

Over the past year, tremendous progress was made toward digitizing and...

How a clinical metadata repository helps with data

How a clinical metadata repository helps with data

Formedix | 22-Mar-2021 | Technical / White Paper

This article covers the various ways a clinical metadata repository helps with data quality, and in turn, with data quality in the clinical trials process....

Related suppliers

Follow us

Products

View more

Webinars