Effective teamwork delivers a CV Outcomes sNDA submission in just 6 weeks
We supported a major pharma client with an add-on indication for an established antiplatelet drug, including a 20,000-patient cardiovascular outcome trial CTD submission to the FDA and EMA.
the challenge
The goal was to deliver a CSR and Clinical CTD 6 weeks after database lock—an accelerated timeline never achieved before by the client.
our approach
We assigned a Senior Lead Medical Writer who optimized communication with the client’s team to help build a good rapport, and built a highly effective and collaborative team within Audubon under her lead. We used time zones and teamwork to operate around the clock, championed innovative planning activities to ensure ambitious timings were achievable, implemented a best practice communications strategy, and enforced standards to ensure quality of documents. We also applied lean principles for maximum re-use of information across documents.
“Knowing I could rely on Audubon to deliver quality took a weight off my mind during a stressful time.”
the results
Just 6 weeks after database lock, all documents were delivered with high quality. The FDA approved the indication within 6 months (accelerated review status), and the EMA approved the indication within 11 months, with no delays.
our value
We were fully integrated into the client’s organization and built excellent and enduring working relationships. We stepped up in leadership to proactively drive the client’s teams to contribute and stay focused, and remained flexible and responsive to changing circumstances/data and additional work requests.
“I had forgotten the Audubon team members were contractors.”