Designing and Building for Multiple EDC Systems

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Freedom to choose your EDC

Each EDC system supports a different set of features and presents forms in a different way, making our unique partnerships with EDC vendors so useful. Formedix On is the only solution with these partner integrations, giving access to the features of all these leading EDC systems. You have the freedom to choose which EDC system is best for running a given study.

Form design

Designing CRFs for your study is critically important, highlighting the need for clear, unambiguous specifications. This is a major focus at Formedix and we have worked hard to optimize the form design process. A key feature is the ability to see how your forms will look in your chosen EDC system, at design time.  You know exactly what you're going to get. Gone is the need to pass specifications to a partner to build the forms, only to discover weeks later they are not as you expected. With Formedix On, you are in control.

Form Visualizations for Multiple EDC Systems

Edit check design

Edit checks are often the most complex part of a study. Formedix On allows design of edit checks for your chosen EDC system, all within one environment. These can be reused from study to study, greatly reducing design time.

Verification checks

Built in verification checks ensure your studies conform to any relevant standards and are valid for your choice of EDC system.

Automatic build of your EDC database

A build file for your chosen EDC system is automatically created, ensuring your design is instantly and accurately turned into your EDC database. Your designs won't be misinterpreted. What you see is what you get.

Migrating between EDC systems

Formedix On solves common challenges of working with multiple systems such as migrating studies between systems, training teams in multiple EDC solutions, and difficulty building studies from existing standards. Your standards and study designs are independent of the EDC system and studies can be run in different systems with just a few clicks.

With Formedix On:

  • Studies can be easily migrated to a different EDC system
  • Studies designed in Medidata Rave can be brought into Formedix On, with no loss of information
  • Studies designed in an EDC system that supports CDISC ODM study design metadata can easily be migrated to another system.
Standardizing content

With your study design in place, it's a simple process to move any content through the standardization process to enable its use in future studies, increasing data quality and reducing design time.

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62% reduction in overall EDC setup cost

Overall EDC setup cost
reduced by 62%

 

75% reduction in Professional services costs

Professional services costs
reduced by 75%

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 provides study build file

Using our solution a sponsor can design studies, from their own organizational standards, and produce an EDC build file to pass to a CRO.

  • Sponsor has full control over the study design and build
  • Automated from the sponsor's specification, greatly reducing QC time
  • Study execution is then managed by the CRO who delivers the resulting datasets back to the sponsor.
Sponsor provides study designs

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

  • Sponsor has full control over the content of the study
  • CRO can access study designs from Formedix On or these can be published in a suitable format
  • CRO can build using their existing processes and preferred EDC.
Sponsor provides standards

A sponsor can develop organizational standards for their data, and pass those standards to a CRO to create the study design and build.

  • Sponsor has overall control over how their data is collected
  • CRO can access the standards and build the study design inside Formedix On
  • CRO benefits from time saving features such as automated EDC build, and can use their preferred EDC system.

Alternatively the standards can be published to a file and made available to a CRO, who can then design and build the study 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.
Formedix On logo

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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