SDTM

From the collected data and external results, we pledge to produce a compliant package that will include the following deliverables:

  • SDTM datasets in XPT format
  • Annotated CRF (aCRF)
  • Define.xml file
  • cSDRG (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.

Thanks to our experience, the early establishment of the data transformation pipeline and the regular transformation of data during the study ensures cleaner final 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.

ADaM & TFL

The ADaM package is produced from SDTM data and the Statistical Analysis Plan ; it includes the following deliverables:

  • ADaM datasets in XPT format
  • Define.xml file
  • ADRG (Analysis Data Reviewer's Guide)
  • Optionally, ARM (Analysis Result Metadata)
  • P21 report in Excel format

To facilitate the reviewer's understanding, we take the utmost care in producing the ADRG and define.xml documents :

  • Detailed textual description of the derivation and structure of each dataset
  • Simple, clear explanations for the derivation of variables

As for the TFL, they are generated using AdClin's Clinical Reporting Solution. We produce them in HTML, Word, and PDF formats.

From experience, the early establishment of the SDTM/ADaM/TFL process enables us to deliver the final TFL very quickly after the database freeze.

Standardization of legacy studies to SDTM/ADaM formats

From legacy studies where the CSR was not produced according to standards, AdClin can produce the corresponding SDTM/ADaM packages.

The challenge in this step is to best align the collected data with the SDTM standards and to reproduce the TFL from the CSR using the standardized ADaM analysis datasets.

The main TFL of the study are generated from the ADaM datasets and are compared with the TFL from the CSR. The comparison of these TFL is provided to the client in a report.

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.