Submissions expertise rescues a BLA submission
We supported a small pharma client with a BLA for a rare disease.
the challenge
A prior CRO had failed to deliver a quality clinical CTD (Overview, Summaries, and CSR), and the client replaced that CRO with an Audubon team just 6 weeks before their target submission date. Audubon had to start from scratch and deliver a full suite of quality documents within 4 weeks, having never worked with this client before.
our approach
We assigned a project manager and 3 medical writers solely dedicated to the project over the 4 weeks, integrated with the client’s team, and continuously directed the team in a unified effort. We collaborated in a remote war room where all key stakeholders, decision-makers, and team members operated in a distraction-free zone with seamless and immediate communication. We used topic-based authoring to achieve efficiency, consistent messaging, and the agility needed to create the clinical CTD with speed and accuracy, and applied lean principles for maximum re-use of information across documents by hyperlinking.
“You all gave the sense of real partners who took ownership of the project and showed real caring on the quality and accuracy. There is no doubt in my mind that without your guidance, help and actual contributions, we would never have been able to complete this undertaking in the time and way we did.”
the results
The CSR and clinical CTD Overview and Summaries were delivered in 3.5 weeks, giving the publishing provider 2 weeks for publishing.
our value
Extensive experience of regulatory submissions instills a sense of security and confidence in the client’s less experienced team, empowering them to contribute effectively and feel supported. Our comprehensive understanding of drug development and experience with hundreds of programs allows us to quickly assimilate complex information and effectively document the development story. Excellent teamwork, communications, and commitment enables the Audubon-client team to function as a cohesive and efficient unit under pressure and meet very tight deadlines.
“The insights, guidance, content development and project management provided by this Audubon team – combined with their seemingly limitless energy – made the nearly impossible a reality. I cannot imagine there is a better medical writing team anywhere.
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