1.
WHEN FDA GUIDANCE
AND TECHNOLOGY
INNOVATION MEET

2.
the Food and Drug
Administration released
Clinical Trial Imaging Endpoint
Process Standards guidance
for clinical trials industry.
In March 2015,

3.
TO STANDARDIZE.
TO AUTOMATE.
TO MOVE CLOSER
TO ZERO-DELAY
CLINICAL TRIALS.
WHY?
AND
WHY
NOW?

4.
TECHNOLOGY
Verifies that scans meet
protocol criteria.
Is the critical tool to make this
FDA guidance a reality.
Ensures that image data is
properly de-identified.
Guarantees case report forms are consistent
with the images they complement.

5.
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.

6.
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.
How?
By enhancing site compliance, reducing site queries
and enabling secure electronic transfer of scans
from thousands of locations around the world.

7.
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.

8.
additional standards regarding imaging endpoint
process standardization for clinical trials.
THE GUIDANCE
RECOMMENDS

9.
those standards.
AG MEDNET
MANDATES

10.
AG MEDNET STANDARDS
ENSURE THAT:
A verifiable record of the imaging process exists.
Quality of imaging data is maintained.Imaging data complies with a trial’s protocol.

11.
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.

12.
QUALITY
+ SPEED
AG MEDNET IMPROVES THE
OF CLINICAL TRIALS

13.
by AUTOMATING IMAGE
DATA COLLECTION
and promoting compliance with
trial protocols to ensure images
are consistently performed

14.
WITH THE RIGHT
EQUIPMENT

15.
TO THE RIGHT
SPECIFICATIONS

16.
The FDA and AG Mednet agree that
AUTOMATION
STANDARDIZATION
+

17.
CREATE
CONSISTENCY THAT
DRIVES ACCURATE
CONCLUSIONS.

18.
SAVES
SPONSORS TIME
AND MONEY.

19.
HELPS
CORE LABS EXPAND
BANDWIDTH TO TAKE
ON MORE TRIALS.

20.
Read more about the FDA’s Clinical Trial Imaging Endpoint Process Standards Guidance for Industry here:
http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm268555.pdf
Learn about AG Mednet’s Longitudinal Analysis technology here:
http://www.agmednet.com/clinical-trials-solutions/submission-quality-compliance-module/
Download our white paper to learn how to help the clinical trials industry achieve zero-delay clinical trials.
http://info.agmednet.com/white-paper-quality-begins-at-the-source/?__hssc=&__hstc=&hsCtaTracking=
4a2a0c6c-41a6-40f5-b10c-118932481f22|afb85200-8562-4841-a6f5-151b64b87f17