Leadership and collaboration contributes to Pharma CEO award
We supported a major pharma client with labeling updates for an antidiabetic drug. The information was derived from a combination study of 2 of the client’s antidiabetic medications, and we were tasked with leading and producing the clinical CTD for the EMA and then the FDA following a strategy change.
the challenge
The goals were to manage 2 separate drug development teams who had no unified vision and to respond to a mid-stream strategy change while still delivering to the original short timeline.
our approach
A cross-skill Audubon team comprising a project manager, medical writers, and a QC leader planned, coordinated, and delivered the CTD. The Project Manager took a proactive and leading role to manage process, people, and issues, and orchestrated review of documents by functional groups rather than by individuals to enhance the quality and consistency of feedback while creating a higher degree of accountability and collaboration. The Submission Lead Medical Writer drove process efficiencies that saved time and resources, ensuring consistency and creating high-quality documents, which led to a faster and smoother submission process. The Submission Lead Medical Writer also quickly adapted the CTD strategy to accommodate simultaneous EMA and FDA submissions without incurring delays. The QC leader helped define the project’s quality standards and requirements from the outset, acting less as an auditor and more as a trusted partner and consultant to the project team, and managed the day-to-day workflow of QC activities for all documents, including those authored by the internal team and the client.
the results
All CTD documents were delivered to plan.
our value
Strong leadership, project management, QC, expertise, and overall teamwork ensured delivery to plan and documents of high communications quality. Seamless collaboration with the 2 drug development teams ensured excellent relationships and a high level of trust. Excellent communication and behavior enabled us to stay on task, manage issues effectively, and maintain momentum, while adaptability and skilled conflict-resolution maintained team cohesion. Establishing quality as core to the entire project’s DNA, rather than a final gate at the end, delivered higher quality faster and more efficiently.
“I was particularly pleased with how Audubon managed the submission process from end to end in a very efficient and coordinated way, driving consistency across documents. They were flexible when we changed course on strategy.”