Designing and Converting Datasets

CDISC SDTM Dataset icon
Design your datasets up front

Datasets are a core part of what we submit to the regulator to get our drugs or devices approved. Despite this they are often ignored in the early stages of a study, which can lead to delays downstream and perhaps the discovery that the collected data is not exactly what it needs to be. None of us want that.

Datasets should be defined up front, before you collect your data. This is a big change in thinking, but brings many benefits and improves data quality. You can:

Take control of your submission from the start of a study to avoid unpleasant surprises.

Dataset definition

Formedix On has been optimized to make dataset definition as simple and painless as possible.

  • Supports the latest CDISC standards such as SDTM, ADaM, SEND and Define-XML
  • Get up and running with a basic set of CDISC-compliant datasets in just a few clicks
  • Value lists, supplemental qualifiers, terminologies and algorithms can all be easily managed.

Formedix On is a CDISC expert, so you don't have to be.

At the click of a button you can view how the dataset designs will appear to regulators reviewing your submission. It's a simple process to move them through the standardization process to enable their use in future studies, increasing data quality and reducing design time.

Mapping and converting data from EDC datasets

Once dataset structures have been defined, they are mapped back to the source EDC datasets. Unlike a generic ETL tool, Formedix On understands CDISC standards, leaving you to provide the real data mappings rather than programming rules about how to create CDISC datasets. A traceability report helps you ensure all the data is mapped.

Mappings are easy to understand and are described and managed as metadata. They can be defined up front, before collecting data, and be standardized along with all the other study metadata. This allows reuse, driving faster study designs and increasing data quality.

Most important of all, the mappings are machine readable. This means once they have been defined and approved, they can be used to generate the target datasets. No need for programmers to double program data conversions from your specifications. Once the mappings are verified, you know your datasets will be right.

With the mappings defined before study initiation, as soon as your first EDC datasets are available you can begin to generate interim target datasets.

Verification checks

Built in verification checks ensure your datasets conform to any relevant standards such as SDTM, ADaM, SEND and Define-XML.

Migrating between EDC systems

Every EDC system creates different dataset structures, so mappings to your submission datasets need updated when moving to a new system. Formedix On shows what the datasets will look like for each system, making it simple to update mappings to match your chosen EDC.

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70% reduction in dataset creation time

Dataset creation time
reduced by 70%

Generating Define-XML Metadata For Legacy XPT Datasets

It is now a regulatory requirement to submit Define-XML metadata describing your datasets, however many organizations still have legacy datasets that don't have any associated metadata. Using our Convert SAS XPT to Define-XML On Demand Service it's simple to generate Define-XML for these datasets, allowing them to be used in a submission.

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Building Studies from Standards

Building a study from a set of standards is extremely simple and streamlines the clinical lifecycle while increasing data quality.

Build studies from standards process diagram
  • Choose your forms and related datasets directly from your standards - no need to create them manually
  • Edit checks, mappings and other related metadata are brought in automatically from your standards so you know they're correct
  • Add protocol-specific information such as the visit schedule, custom edit checks, or custom mappings
  • Visualize how the CRFs will look in your preferred EDC system to ensure they are correct
  • Once you're done, compliance checking shows any deviations from your standards.

This all happens within a governance workflow ensuring you have control over your study designs.

Once the study design is complete it can be exported to your choice of EDC system. No manual build time is required, and you know the study database is exactly as you designed. You're also ready to generate interim downstream datasets once the data starts coming in, as the mappings are part of the study design. No need to code your data conversions for each study.

Working with CROs

Formedix On enables sponsors and CROs to work together in new ways, improving communication and driving efficiencies.

Sponsor generates submission datasets in house

Formedix On allows the sponsor to take control of dataset generation if they wish.

  • Sponsor receives raw EDC datasets from CRO
  • Mapping and conversion handled by the sponsor - no need for programming or SAS expertise
  • Sponsor has full control over their submission datasets.
Sponsor provides submission dataset designs

Alternatively, a sponsor can choose to design the datasets and pass the specifications to the CRO.

Sponsor provides standards

A sponsor may develop organizational standards for their datasets, and pass those standards over to a CRO to design the study datasets.

Alternatively the standards can be published to a file and made available to a CRO, who can then design and convert the datasets using their existing process.

Full Service CRO

Formedix On allows a CRO to manage the entire end to end study design, execution and submission.

  • CRO can design for multiple EDC systems, taking advantage of instant CRF visualizations and automated EDC build
  • CRO can rapidly map and convert data to submission datasets without the need for programming or SAS expertise
  • CRO benefits from Formedix On's knowledge of CDISC standards and efficiencies through re-use of designs
  • CRO can give their customers access to view or participate in the study designs.
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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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