Case Studies
Supporting the Full Approval of a Life-Saving Bacterial Vaccine
Secured full approval for a life-saving bacterial vaccine in 2024 through precise SDTM submission, managing regulatory requests and tight deadlines.
- Client: A Global Pharmaceutical Company
- Year: 2020-2022
- Impact: Ensured regulatory compliance, expedited approval, protected vulnerable populations.
Delivering a High-Stakes Vaccine Submission Under Pressure
Led SDTM for a first-in-class vaccine, managing regulatory requests and tight deadlines. Delivered submission-ready datasets, leading to vaccine approval.
- Client: A Global Pharmaceutical Company
- Year: 2023-2024
- Impact: Ensured compliance, expedited approval, and supported public health efforts.
Converting Legacy Data to CDISC Standards for Regulatory Submission
Converted legacy data to CDISC standards, addressing format issues and protocol deviations. Developed custom solutions for SDTM IG 3.3 alignment, ensuring regulatory compliance and successful submission.
- Client: A Global Pharmaceutical Company
- Year: 2024
- Impact: Enabled the company to leverage historical data, strengthening their submission and securing regulatory acceptance.
Rescuing a Multi-Vaccine Study Through Data Interpretation and Remapping
Rescued a multi-vaccine study by interpreting and remapping unusable SDTM data after data collection issues. Increased data usability from 27% to 96%, ensuring a strong regulatory submission. Reinforced the importance of early data cleaning and proactive issue resolution.
- Client: A Global Pharmaceutical Company
- Year: 2024
- Impact: Ensured regulatory acceptance, prevented potential delays, and reinforced the importance of early data cleaning and proactive issue resolution in clinical trials.