Because she started her career
as a medical writer, Sandy focuses on
helping companies write concise, efficient
FDA meeting requests and briefing documents,
clinical protocols, investigator brochures,
and other key clinical trial application
(CTA) submission documents to comply with
current regulations, and relevant guidance
for specific indications, types of products
(e.g., gene therapies), and International
Conference on Harmonisation (ICH) topics.
She also specializes in writing INDs that
can be easily transformed into (or from)
CTAs in other world regions. Her
long-standing interest in writing and clear
language ensures the non-native English
writing of her foreign clients is easily
understood by FDA, resulting in fewer FDA
questions and a faster path to the market.
Sandy helps her clients meet orphan drug,
clinical trial, drug safety
/pharmacovigilance, and marketing
application requirements to ensure
multi-region projects are handled in the
most efficient way. She and her colleagues
ensure an initial clinical trial application
(e.g., an IND for FDA) is complete and
concise, facilitating its prompt, successful
FDA review resulting in an FDA “allowed to
proceed” decision. She 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.
Because Sandy lives and
works near FDA, she frequently participates
in FDA “information for the industry” and
FDA Advisory Committee meetings that relate
to her clients’ projects.