Leadership and project management delivers a complex record-breaking accelerated CTD submission
We supported a major pharma client with a large, complex, accelerated CTD submission 16 weeks after LSLV of the last phase 3 study. We simultaneously submitted 2 respiratory indications to 4 major agencies (US, EU, China, and Japan)—another first for the client—and delivered a Message Map, Clinical Overviews, and Efficacy and Safety Summaries involving 9 studies, including 6 phase 3 studies.
the challenge
The goal was to deliver the largest, most complex, and fastest submission ever achieved by this client, developing summary documents suitable for all 4 agencies concurrently while aligning with the client’s team developing the six phase 3 CSRs. Pressures during authoring were significant: study results were not straightforward, major changes were required after feedback from the FDA and EMA, and the aggressive timeline had no buffer.
our approach
We continuously re-negotiated with the client’s project team to adjust the plan to accommodate changes impacting document development. We conducted a lessons learned after the document pre-write period, prior to data availability, and those insights shaped workflows in the post-data period. A topic-based authoring approach achieved efficiency, consistent messaging, and the agility needed to adapt to changes, while a lean authoring approach produced documents within the ICH page limit despite submission size and complexity. A dedicated and experienced Lead Document Manager developed the rigorous submission QC plan necessary for such a complex submission, and we provided a framework to proactively prepare responses for RTQs.
the results
All submission documents were delivered to plan and simultaneously filed with the US, EU, China, and Japan agencies—a first for this client. Shortly after, the submission was accepted for review by all 4 agencies.
our value
We are highly experienced in leading clinical CTDs and able to provide expert advice and guidance to the client’s team. Our highly adaptive, client-focused, and proactive project management allows us to navigate project changes—such as shifting requirements and new information—without sacrificing quality or stakeholder satisfaction.