Leadership and project management delivers a complex record-breaking accelerated CTD submission

 

scope

  • Supported a major pharma client with a large, complex, accelerated CTD submission 16 weeks after LSLV of last phase 3 study.

  • Simultaneously submitted 2 respiratory indications to 4 major agencies (US, EU, China, and Japan), another first for the client.

  • Delivered Message Map, Clinical Overviews, and Efficacy and Safety Summaries involving 9 studies (including 6 phase 3 studies). 

the challenge

  • To deliver the largest, most complex, and fastest submission ever achieved by this client. 

  • To develop summary documents suitable for all 4 agencies concurrently, while aligning with the client’s team developing the six phase 3 CSRs. 

  • Significant pressures during authoring: study results were not straightforward; major changes were required after feedback from the FDA and EMA; the aggressive timeline had no buffer.

our solution

  • Continuously re-negotiated with client’s project team to adjust the plan to accommodate the changes impacting document development.

  • Conducted a lessons learned after the document pre-write period, prior to data availability. The insights shaped workflows in the post data period.

  • Topic-based authoring approach achieved efficiency, consistent messaging, and the agility needed to adapt to changes. 

  • Lean authoring approach produced documents within the ICH page limit, despite submission size and complexity. 

  • Dedicated and experienced Lead Document Manager developed the rigorous submission QC plan necessary for such a complex submission.

  • 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

  • Highly experienced in leading clinical CTDs and able to provide expert advice and guidance to the client’s team.

  • Highly adaptive, client-focused, and proactive project management.

  • Able to navigate project changes, such as shifting requirements and new information, without sacrificing quality or stakeholder satisfaction.

 

CTD, Common Technical Document; EMA, European Medicines Agency; EU, European Union; FDA, Food and Drug Administration; ICH, International Council on Harmonisation; LSLV, last subject last visit; QC, quality control; RTQ, Regulatory Technical Query; US, United States.