Verifying Study Deliverables

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Verifying that deliverables match specifications or standards is a core part of an efficient study process

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.

Verify CRO datasets against your specification

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:

  • Are all the expected datasets present?
  • Are all the expected variables present and in the correct order?
  • Do the variables have the correct datatype?
  • Does the data conform to the expected terminologies?
Verify an EDC build

Ensure a CRO has correctly implemented your EDC system by comparing the output datasets to the datasets expected from the study design.

Verify CRO datasets against SDTM, ADaM, SEND and NCI Terminology

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.

Verify study designs against organizational standards

Easily see any deviations between your studies and your internal standards, before approving study designs.

Verify dataset designs against SDTM, ADaM, SEND, NCI Terminology and Define-XML

Whether designing datasets inside Formedix On or in another system, verify that the designs conform to all the relevant industry standards.

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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.

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