FDA
requires that Sponsor companies conducting
clinical trials in the US must have a US
address or office, or the Sponsor must
interact with FDA through a “US Agent.”
Sandy specializes in being a US Agent given
her long experience working internationally
and with FDA. She ensures the initial US
clinical trial application (IND) is complete
and concise, facilitating its prompt,
successful review, and ability to proceed.
Since INDs are filed electronically to FDA
in eCTD format, Sandy works with the Sponsor
to determine best placement of its data,
given its unique project’s history, with an
eye toward efficient updating of the IND
over the life of the project. Although FDA
provides a mapping chart citing where in the
CTD IND information required by US
regulation should be placed, the guidance is
vague, particularly about where to put
clinical data from earlier studies conducted
elsewhere in the world. Best placement
depends on many factors, which Sandy can
help decide. Also, unlike many countries for
which a new clinical trial application is
filed for each protocol, the US process is
for all protocols for the project to be
filed to the same IND, meaning consistent
and efficient filing of data throughout the
life of the IND is critically important for
eventual review of the marketing
application.
Once an IND is filed, Sandy maintains the
IND/CTA by filing protocol amendments,
annual reports/DSURs, time-sensitive safety
information for clinical trial patients, FDA
meeting requests, and ensures all project
regulatory requirements are met. Sandy
frequently interacts with FDA staff to
ensure projects stay on track.
