Frequently Asked Questions
JetConvert is a purpose-built SDTM conversion software that enables our SDTM experts to produce SDTM submission packages much faster and more cost-effective than industry standards.
No, it also produces the annotated CRF, Define-XML and cSDRG as required for a SDTM submission package. However, JetConvert is only intended to produce SDTM deliverables, and not ADaM or other analysis outputs.
Yes, JetConvert has a Computer System Validation (CSV) package documenting the entire system development life cycle. It does comply with the requirements as documented in Part 11 (where relevant). Our team also follows a set of SOPs to describe how JetConvert should be used, and they are trained on the system and all other relevant topics.