Precise planning delivers a CTD submission just 7 days after final data
We supported a major pharma client with a CTD submission for a statin drug to treat pediatric homozygous hypercholesterolemia, and were tasked with leading the clinical CTD and the responses to the FDA’s subsequent questions.
the challenge
The goal was to submit the CTD to the FDA very soon after final data were available and before a patent expiry.
our approach
All CTD modules were prototyped in advance using draft data. We assigned a Submission Lead Medical Writer with experience of the drug, key people on the project, and leading clinical CTDs. The Submission Lead Medical Writer and the Audubon Project Manager devised a comprehensive daily plan for the period after final data, which—drawing upon lessons learned from document prototyping—coordinated authorship, review, and QC activities across the CTD. Our Submission Lead Medical Writer worked at the client’s site during the final data phase to get on-the-spot decisions, and meticulous orchestration of the plan meant the medical writing team delivered quality at speed.
the results
The clinical CTD was delivered 7 calendar days after the final data were available. The FDA approved the indication following a priority review, which made a drug patent extension possible.
our value
Effective planning, leadership, project management, QC, and close work with the client ensured the CTD was consistent, of high communication quality, and delivered at rapid speed. Dedication to the project and continuity of support drove efficiency and strengthened relationships. The client requested the same medical writer to lead the EMA submission, which again was done with quality and speed.
“I think you rose to the challenge and established yourselves on a high and very valuable level, which has helped us achieve unprecedented goals. I see no reason to have an internal Submissions Lead Medical Writer, because you have established this high level of value add. It has been truly great to see.”