Advancing Global Regulatory Submissions through Next Generation Submission (NGS): A Collaborative Implementation Case Study

About this session

Part of Session 4, Track B: Submissions (Chair: Asif Karbhari, AstraZeneca).

The adoption of Next Generation Submission(NGS) levers is transforming our preparation of global regulatory submissions and enabling accelerated timelines thru standardized, automation-driven, more efficient processes. This paper presents a collaborative submission acceleration of NGS implementation between a CRO and a global sponsor, focusing on pre-DBL planning, Dress Rehearsal approach, and post-DBL strategies. Key NGS levers include alignment with CDISC standards for multi-regional submissions, a shadow team for early restricted unblinded PK/popPKPD data access and analysis readiness, a CSR reduction plan and checklist, and an automation-enhanced process for in-text tables and safety narratives. Challenges like cross-functional coordination, Intercurrent Event(ICE) handling, prompt third-party vendor(TPV) data transfer and issue handling, and regional regulatory variability were addressed through structured governance and iterative approaches. This case study provides practical insights and best practices for accelerated, scalable, future-ready, global submissions leveraging NGS principles. Results demonstrate improved submission process, consistent quality, reduced timelines, and enhanced regulatory compliance

Speakers

• CZ

  Carrie Zhang

  ClinChoice

  Speaker

• AK

  Asif Karbhari

  AstraZeneca

  Speaker