Strategic leadership delivers a commercially sensitive CTD
We supported a major pharma client with a paediatric indication for an asthma drug in the US, and were tasked with leading the clinical CTD and medical writers from both the client and another CRO.
the challenge
The goal was to make up for Phase 3 study delays and submit the CTD before a patent expiry.
our approach
We assigned a Submission Lead Medical Writer with experience of the drug, key people on the project, and leading clinical CTDs. Taking a strategic approach, she led the medical writing team to deliver the CTD efficiently. She produced a Submission Communication Strategy to agree key messages and overall approach, developed the Pre-NDA Briefing Book to clarify the scope of the documentation and data, and created a CTD Clinical Overview shell to guide the format and content of the Phase 3 CSR and CTD Summaries. She ensured the CRO’s and client’s medical writers developed the CSR and CTD Summaries in line with the strategy, oversaw the CSR message map development, and prioritized the large number of statistical outputs of key study endpoints to raise the quality of the CSR. These actions accelerated document production when data became available and ensured a quality CTD. The same Submission Lead Medical Writer also developed the responses to the FDA’s questions following the submission.
“We’re very grateful for your knowledge and guidance in delivering this submission.”
the results
The submission was delivered 6 weeks earlier than planned. The FDA approved the indication and granted 6 months of pediatric exclusivity.
our value
Strategic leadership ensured the CTD and RTQ responses were aligned with the strategy, and the product labeling was of the highest quality. Audubon is able to lead a team of medical writers from other companies.
“The whole team is so happy for having had your support with this.”