Delivering a High-Stakes Vaccine Submission Under Pressure
- Client: A Global Pharmaceutical Company
- Year: 2023-2024
- Impact: Ensured compliance, expedited approval, and supported public health efforts.
A global pharmaceutical company faced an intense regulatory submission process for a first-in-class vaccine targeting a serious respiratory illness in older adults. With tight deadlines, evolving data requirements, and numerous regulatory information requests, the submission demanded both speed and precision.
As part of the SDTM team, we managed:
Frequent and complex requests from regulatory authorities, requiring rapid updates to datasets.
Significant structural changes to SDTM datasets, ensuring compliance with evolving submission standards.
High-pressure deadlines, where efficiency and accuracy were critical to meeting approval timelines.
Despite these challenges, we successfully delivered high-quality, submission-ready SDTM datasets, ensuring seamless integration into the regulatory process. The vaccine was approved and became a key asset in the fight against respiratory illness, providing critical protection to vulnerable populations.
This experience reinforced the importance of technical expertise, adaptability, and leadership under pressure in navigating the complexities of regulatory submissions.
