The Food and Drug Administration (FDA) released Clinical Trial Imaging Endpoint Process Standards guidance for clinical trials industry. Why? To standardize. To automate. To move closer to zero-delay clinical trials. Read AG Mednet's perspective on this FDA guidance.
WHEN FDA GUIDANCE
the Food and Drug
Clinical Trial Imaging Endpoint
Process Standards guidance
for clinical trials industry.
In March 2015,
TO MOVE CLOSER
Verifies that scans meet
Is the critical tool to make this
FDA guidance a reality.
Ensures that image data is
Guarantees case report forms are consistent
with the images they complement.
Sponsors must optimize the quality of
imaging data obtained in clinical trials.
With the increased significance of patient
scans as surrogate endpoints in clinical
trials, the ability to collect imaging data
that meets protocol requirements
is more important than ever before.
AG Mednet technology
meets and exceeds
this FDA guidance.
Sponsors, core labs and clinical research organizations
(CROs) collecting imaging time points as part of their
trial protocols rely on AG Mednet’s automated system.
By enhancing site compliance, reducing site queries
and enabling secure electronic transfer of scans
from thousands of locations around the world.
Aligning with AG Mednet’s core technology,
the FDA guidance focuses on:
critical imaging acquisition, display, archiving, and
interpretation process standards when imaging is
used to assess a trial’s primary endpoint.
additional standards regarding imaging endpoint
process standardization for clinical trials.
AG MEDNET STANDARDS
A verifiable record of the imaging process exists.
Quality of imaging data is maintained.Imaging data complies with a trial’s protocol.
AG Mednet’s Submission Quality & Compliance with
Longitudinal Analysis is the only automated software that
checks data across subject visits – at the source – and makes
determinations about consistency and validity of imaging
data as a clinical trial progresses.
AG MEDNET IMPROVES THE
OF CLINICAL TRIALS
by AUTOMATING IMAGE
and promoting compliance with
trial protocols to ensure images
are consistently performed
CORE LABS EXPAND
BANDWIDTH TO TAKE
ON MORE TRIALS.
Read more about the FDA’s Clinical Trial Imaging Endpoint Process Standards Guidance for Industry here:
Learn about AG Mednet’s Longitudinal Analysis technology here:
Download our white paper to learn how to help the clinical trials industry achieve zero-delay clinical trials.