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, it does comply with all Part 11 requirements (where applicable) and the entire Software Development Lifecycle (SDLC) are documented in a secure DevOps tool. Our development team and users follow a set of SOPs that describes the SDLC process and how JetConvert should be used to deliver SDTM. All users and developers are trained accordingly.
