Client: Midsize Pharmaceutical Company
A midsize pharmaceutical company (Sponsor) was submitting their first ever NDA application to the FDA. As per their discussion at the pre-NDA meeting with the review division at the FDA, the Sponsor’s commitment was to submit clinical data sets in addition to the ISS and BIMO data sets for six studies – three Phase I, one Phase II and two Phase III:
- Tabulation data sets in CDISC SDTM format for all studies.
- Phase II and Phase III analysis data sets in CDISC ADaM format.
- Integrated Summary of Safety (ISS) in CDISC ADaM format.
- Summary Level Clinical Site (BIMO) data set and Site Level Subject Data Listings.
- All data sets should be submitted as per the standards defined under Study Data Technical Conformance Guide.
- Table 1 provides a summary of the six studies to be included in the NDA submission along with the information about the format of tabulation and analysis datasets.
After we did the above gap assessment, the Sponsor asked us to confirm whether we will be able to take on the task to meet their submission timeline. Based on our experience and taking an inventory of all the study documentation, we thought our team would be able to remediate and fix all the gaps and have the complete data set package ready
Importance of Niche Provider for Successful NDA Submission:
Rescue Case Study, continued 6 within 10 weeks. Upon our confirmation, the Sponsor made the decision for us to step in and rescue them from the current situation. Our team was assigned to work with CRO 1 to review and provide feedback on the SDTM domains and any compliance issues.
We were responsible to put together submission documents that were not in place yet (SDTM aCRF, Reviewer’s Guide, and define.xml). Also, we were tasked to put together define files (define.pdf) for the analysis datasets for all 3 studies. Provided traceability report to the Sponsor between mapped SDTM and existing analysis dataset. Study 4 II Generate define.xml, SDTM aCRF, and reviewer’s guide for both SDTM and ADaM datasets. Add FDA expected variables to the SDTM domains (EPOCH, TRTEMFL) and adjust length of each variables to actual stored data. Generated Trial Design Domains. Work with CRO 2 to get access to the SAS codes for the study. Study 5 III Work with CRO 3 to provide feedback on the define.xml and have them fix any issues pertaining to datasets and define files. We were asked to take over generation of SDTM