Define.xml is the metadata that describes the content and formatting of submission datasets and the...
Use our clinical trial automation software to make SDTM datasets upfront. You can even create them before you have collected any patient data. That way, you get SDTM conversion done early on, and can check that your datasets will meet regulatory requirements. You also get a head start on mapping your ADaM datasets back to SDTM.
Easily design SDTM and ADaM datasets
Use our built-in templates to add domains and variables that are compliant with the relevant versions of CDISC standards. Add any additional metadata – such as supplemental qualifiers, derivation methods, and value lists. You will automatically comply with CDISC Define-XML, SDTM, and ADaM standards.
Create compliant SDTM and ADaM datasets, fast
SDTM and ADaM datasets are essential for your submissions. If you do not get datasets done early on, it can cause delays in the future. You risk not collecting the exact data that’s needed for trial building.
As it stands, your source datasets (from your library or EDC) need a lot of work to get them into SDTM datasets. That takes time and programming skills = money.
SDTM conversion is quick and easy in Formedix. There is no coding, and we use templates to speed things up. Our SDTM mapping tools help you match the variables in SDTM with relevant variables in your source datasets. Once you are done, press a button for your SDTM datasets and SDTM define.xml.
Preview your datasets
See how your datasets will look to regulators reviewing your submission. Either PDF or HTML format. This includes links to pages in external documents, like Annotated CRFs.
Easily do SDTM Mapping
Our SDTM mapping tools make the job of creating and describing your SDTM mappings much easier. Whether it’s simple or complex mappings, Formedix has a user-friendly framework for you.
Convert datasets to SDTM in one click
Once Formedix has shown what your source dataset column headings will be, you can design your SDTM datasets. And because you get this in advance of collecting patient data, you can do your SDTM mappings early on. By the time you get trial data back, your datasets are mapped, and it’s just one click in Formedix for SDTM conversion.
Create standards for reuse
You can standardise and store your datasets for reuse in the future. This increases data quality and saves time and resources.
Easily manage CRO specs
You can make specifications if you’ve got a CRO designing datasets for you. When you get your datasets back, check them against your original specs to ensure they are as you expected.
Reusing datasets and mapping helps to keep consistency across studies and standards. This content has already been approved, so you can use it again and again in the future.
No programming needed
There is no need for any programming knowledge. And you do not need programmers to ‘double programme’ data conversion from your specifications. Our easy-to-use mapping language lets you create machine-readable mappings, without any coding. As a result, you save both time and resource costs.
Clinical trial software is used by CROs, biotechnology, and pharmaceutical companies to facilitate clinical trials...
Annotated CRFs document the location in a database of the data collected for each question...