Taking a metadata-focused approach to defining studies makes this possible, as you have a detailed specification for each part of your study. This enables many types of verification to be performed.
When working with a CRO you will receive back a set of datasets, perhaps directly from the EDC system or in SDTM format. Using Formedix On you can define up front what these datasets should look like, and verify that the delivered datasets are as you expected. Checks include:
Ensure a CRO has correctly implemented your EDC system by comparing the output datasets to the datasets expected from the study design.
If your CRO is responsible for delivering your SDTM, ADaM or SEND datasets, you need to ensure they conform to the relevant standards. Using the datasets themselves or a Define-XML file describing them, Formedix On lets you verify that the datasets conform to the expected standards.
Easily see any deviations between your studies and your internal standards, before approving study designs.
Whether designing datasets inside Formedix On or in another system, verify that the designs conform to all the relevant industry standards.
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.