SEND
From the collected data and external results, we pledge to produce a compliant package that will include the following deliverables:
- SEND datasets in XPT format
- Define.xml file
- nSDRG (non-clinical Study Data Reviewer's Guide)
- P21 report in Excel format
- Detailed report on the data transformation process for the study
Our expertise allows us to work autonomously in producing the various submission package deliverables, only involving you in specific cases such as unexpected data issues or to confirm a choice between several options.
Our process and tools enable us to ensure a high level of data traceability while performing numerous automatic checks to validate the consistency of the data.
Finally, we pay special attention to the writing of the various documents, always trying to put ourselves in the reviewer's shoes to provide the clearest and most understandable explanations possible.
Key contact
The AdClin team is made up of seasoned experts in CDISC standards, with experience ranging from 7 to 25 years.
A single person, mastering all stages of SDTM and ADaM package production, will be your primary point of contact throughout the project.