Can slc meet the standards of FDA for statistical analysis software used by CRO companies?
Can slc meet the standards of FDA for statistical analysis software used by CRO companies?
Find more posts tagged with
I really appreciate your detailed explanation. This is very good news. Thank you again!
As far as I am aware the FDA uses SAS software to run SAS programs with SAS data sets.
Altair SLC can run SAS programs to create SAS data sets, and those SAS programs can be run using SAS software.
TBH I do not believe the FDA will notice, or care, whether Altair SLC or SAS software was used to run the programs and create the data sets sent to them! The FDA already accept data generated using R.
............Phil
PS. However, if you try to run existing SAS programs for the first time in Altair SLC, then you may find that these may fail if they use very new or undocumented features of the SAS programming language!
Hi Philip, have you ever heard of any CRO company that uses SLC to write reports and passes the FDA review? Also, I heard that CDISC has standards for statistical software. Does this have any impact?
Best Regards.
Hi Philip, have you ever heard of any CRO company that uses SLC to write reports and passes the FDA review? Also, I heard that CDISC has standards for statistical software. Does this have any impact?
Best Regards.
I am not aware of any CROs that are currently using Altair SLC, but @Nico Chart may be able to report if there are any, without revealing their names.
I am currently writing a book about SAS programming, which includes chapters about the Altair Analytics Workbench. One chapter looks at whether Altair SLC could be used with clinical trials data processing. I have included some extracts below:
| SAS software licences used to include the SAS Clinical Standards Toolkit (CST) as an optional free component. Since July 2022 this component has been removed from the licence, and moved to GitHub, as a freely available open‑source resource (https://github.com/sassoftware/clinical-standards-toolkit) for all SAS programmers to develop data processing for clinical trials. |
| As soon as I started using the CST sample data I realised that this version of the sample SDTM data had never been used to create the sample ADaM data, so I used Altair SLC to rebuild the necessary metadata, and then generated a consistent set of SDTM and ADaM data. This can now be found at my fork of the CST, which contains only the sample data with most of the unnecessary files from the original CST removed (https://github.com/hollandnumerics/clinical-standards-data). |
I hope this is helpful............Phil
I am not aware of any CROs that are currently using Altair SLC, but @Nico Chart may be able to report if there are any, without revealing their names.
I am currently writing a book about SAS programming, which includes chapters about the Altair Analytics Workbench. One chapter looks at whether Altair SLC could be used with clinical trials data processing. I have included some extracts below:
SAS software licences used to include the SAS Clinical Standards Toolkit (CST) as an optional free component. Since July 2022 this component has been removed from the licence, and moved to GitHub, as a freely available open‑source resource (https://github.com/sassoftware/clinical-standards-toolkit) for all SAS programmers to develop data processing for clinical trials. As soon as I started using the CST sample data I realised that this version of the sample SDTM data had never been used to create the sample ADaM data, so I used Altair SLC to rebuild the necessary metadata, and then generated a consistent set of SDTM and ADaM data. This can now be found at my fork of the CST, which contains only the sample data with most of the unnecessary files from the original CST removed (https://github.com/hollandnumerics/clinical-standards-data).
I hope this is helpful............Phil
Thank you very much and admire your efforts in SAS language. It is really very useful. I wish you all the best.
Please feel free to follow me on my blog site at http://blog.hollandnumerics.org.uk. Details of my new book will be published there first.
..........Phil
Please feel free to follow me on my blog site at http://blog.hollandnumerics.org.uk. Details of my new book will be published there first.
..........Phil
sure!
As far as I am aware the FDA uses SAS software to run SAS programs with SAS data sets.
Altair SLC can run SAS programs to create SAS data sets, and those SAS programs can be run using SAS software.
TBH I do not believe the FDA will notice, or care, whether Altair SLC or SAS software was used to run the programs and create the data sets sent to them! The FDA already accept data generated using R.
............Phil
PS. However, if you try to run existing SAS programs for the first time in Altair SLC, then you may find that these may fail if they use very new or undocumented features of the SAS programming language!
As far as I am aware the FDA uses SAS software to run SAS programs with SAS data sets.
Altair SLC can run SAS programs to create SAS data sets, and those SAS programs can be run using SAS software.
TBH I do not believe the FDA will notice, or care, whether Altair SLC or SAS software was used to run the programs and create the data sets sent to them! The FDA already accept data generated using R.
............Phil
PS. However, if you try to run existing SAS programs for the first time in Altair SLC, then you may find that these may fail if they use very new or undocumented features of the SAS programming language!