Formedix’s clinical metadata repository includes all features required for impact analysis, change request management, and governance, ensuring a company’s workforce can work together seamlessly and collaboratively.
For help in automating study design and build, Formedix’s clinical trial automation tools use content in companies’ existing clinical metadata repository to create studies promptly.
Clinical trial automation
For the development of electronic case report forms (eCRFs), the building of EDCs, the design or conversion of datasets or creating define files, Formedix aids in these processes in a little amount of time.
With the software, users can quickly make study CRF designs and EDC designs from standardised content. The company’s visualisation tool enables users to see what forms will look like and how they work during the design process.
Users can make annotated compliant study data tabulation model (SDTM) datasets and analysis dataset model (ADaM) datasets using Formedix’s templates. The company keeps up-to-date with the latest Clinical Data Interchange Standards Consortium (CDISC) standards, but users can also work with older versions.
Operators can receive submissions using Formedix’s visual define.xml editor, as well as generate define.xml files from statistical analysis software (SAS) Xport transport (XPT) files or old legacy datasets.
Formedix fully integrates with Rave. Users can integrate with seven leading EDCs, as well as personal internal systems using the company’s application programming interface (API), enabling the set-up of automated processes to push data into Formedix and trigger a conversation, pulling datasets back onto the system.
The company complies with regulatory requirements; operators can use Formedix’s validation tools to check CRF and EDC designs, as well as built-in CDISC validations.
CDISC standards compliance
Built on CDISC standards, Formedix’s platform is routinely updated in-line with the relevant standards, and both current and previous versions of CDISC are supported.
The company is on the CDISC Extensible Markup Language (XML) team, involved in creating CDISC operational data model (ODM) and Define models, working with CDISC for more than two decades.
Services and training
As experts in the end-to-end system, Formedix’s professional services team is available to support all clients, offering day-to-day support and helping clients to achieve company objectives.
Formedix also offers training tailored to suit each individual, providing sessions on-site, as well as remotely via webinars, depending on what satisfies each organisation best.