The integration of historical clinical study data into one standardized and submission-ready format can be a challenging with legacy studies. We can provide the expertise and consultation needed when preparing clinical data across studies for a regulatory submission. Collaboration with the sponsor is essential through the process, especially when defining patient populations, summarization algorithms, summary tables and graphs etc… We can support your team so you can focus on other components of your regulatory submission!
Our team of statisticians and programmers will:
- Standardize data into SDTM / ADaM formats
- Develop a submission strategy and SAP
- Convert legacy data into submission ready formats: MedDRA | WHODrug Global
- Create submission required database documentation