Formedix On makes it simple to generate annotated CRFs with minimal effort. Gone are the days of manually creating it each time and having to verify that it matches the collected data. Once the data acquisition forms for your study have been defined up front, you can add annotations describing where the data flows to in your SDTM. Then it's a simple push of a button to generate a regulatory-compliant annotated CRF. It's based on your original study design, so you know it's right.
If you need detailed control over the form layouts, you've got it. You can even have branded headers and footers if you like.
When you have end-to-end standards, your data acquisition forms are aligned with your downstream datasets. When creating a study from your standards, everything comes along. Your forms, terminologies, edit checks, datasets, and the annotations that drive the annotated CRF. In other words, once you have created your standard annotated CRFs you can reuse them from study to study.
No more rushing to manually create your annotated CRF when pulling together your submission.
Formedix On is a powerful platform designed to accelerate your clinical trials and drive data quality through the standardization and reuse of metadata. It is based on CDISC standards, facilitating regulatory compliance with the FDA, PMDA, EMA and other regulators.
With Formedix On you can:
Support for industry standards such as SDTM, ADaM, SEND, Define-XML, Analysis Results Metadata, Dataset-XML and ODM comes built in. In fact, Formedix have been active members of CDISC since 2001 and our products are CDISC certified.