Bioforum’s SDTM experts have developed a next generation SDTM automation platform, JetConvert, that allows us to deliver a SDTM submission-ready package in 3 weeks with superior quality and at least 25% less cost compared to the industry average.
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.
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.
