GET THE PERFECT MATCH

With our validation tools you can ‘spot the difference’ and correct any inconsistencies.

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VALIDATION MADE EASY

Is your data in good shape? Is it FDA compliant? Formedix carries out systematic checks throughout the design and build process to make sure of it.

One way we do it is by comparing what you’re supposed to have against the files you’ve ended up with. This could mean comparing studies against specifications, or against your organizational standards. That way you get to see any differences before approving your study designs.

If you’re working with a CRO, you can check what you get back from them too. Formedix shows what your form designs will look like in your EDC system. Like a preview. You can then compare this with the EDC datasets your CRO passes on, to see if they match up.

Formedix also validates your datasets against relevant industry standards – including as SDTM, ADaM and SEND. Even if a CRO does this for you, we can still check that your datasets conform to the right standards.

What can I do with Formedix?

WHAT'S IN IT FOR ME?

IMPROVE CONSISTENCY

Formedix makes it easy to see any differences between your original specs, and the datasets you get back. Our built-in rules and processes help you avoid any inconsistencies that could affect your FDA submission.

EFFORTLESSLY COMPLY WITH STANDARDS

No worries about meeting regulatory standards. Formedix is built on the latest CDISC compliant templates, so you automatically comply with the latest FDA and NCI standards.

EFFORTLESS EDC VALIDATION

Formedix validates against the rules for your relevant EDC system – even if you’re using different EDCs for study phases. And because you can work on content in your EDC system straight from Formedix, it makes validating CRF specs against your eCRFs in your EDC much easier.

SAVE TIME & SUBMIT STUDIES FASTER

Because validation is built in throughout Formedix from the start, you save precious time during study build. Now you can submit studies faster, as validation has been done continuously, and not left until the end. 

IS YOUR DATA CDISC COMPLIANT?

Formedix makes sure of it, with built in rules to automatically validate against non-compliance.

HOW WE MAKE VALIDATION EASIER

Types of validation
For clinical trials, there are many types of validation to be done. For example:

  • Validation of CRF design against clinical expectation
  • Validation of EDC design against CRF specifications
  • Validation of EDC Clinical datasets against dataset specification
  • Validation of SDTM dataset design against CDISC standards (SDTM-IG, NCI Controlled terms etc.)
  • Validation of SDTM programming
  • Validation of SDTM Clinical Data against CDISC (SDTM), NCI standards and FDA or PMDA rules.

Validation steps
There are many different steps to consider. Some of these can be included in the design process to build conformance in from the start. When it comes to validating the CRF with clinical oversight, it’s important to be able to quickly review and adjust things like form layout, question wording and controlled terms. A web based system makes this easier, since teams often work in different locations.

Easier validation – work directly in your EDC 
If you’re working directly on content in your EDC system – as you can do in Formedix – this makes validating the CRF specification against the eCRF in your EDC much easier. It’s literally a case of, ‘what you see is what you get’ in the EDC. This is also true for datasets. By producing a specification for each stage of the EDC to SDTM conversion process, you can review and test the design with test data – before the EDC system is live. Once your clinical data is available, by complying with the expected dataset specifications, you know the conversion process will also work as expected.

Easier compliance with CDISC standards
For submission deliverables – such as SDTM datasets – the metadata and data within the datasets (and Define-XML) must conform to the CDISC SDTM-IG standards. In basic terms, this standard dictates the column names, labels and column order of the datasets. Compliance against this standard can be measured if the SDTM specification itself is compliant. Formedix cross checks the clinical datasets against the specification for you.

EFFORTLESS SDTM DATASETS

Formedix makes SDTM dataset creation far easier, with CDISC SDTM metadata templates. That way you build your datasets in line with CDISC SDTM rules, right from the off!

MAXIMIZE COMPLIANCE - DO IT FROM THE START

The pitfalls of programming validation
Programming validation requires a different approach. The most common cause of problems are human errors. After creating an SDTM compliant specification, this is then divided into separate programming tasks. If each task is then programmed by two different teams, a comparison of the outputs will eliminate most human errors. But you must still compare the output with the specification to ensure compliance.

Rule based templates make SDTM datasets easier
Each SDTM dataset starts as a specification in the Formedix platform. Our dataset design tools contain the CDISC SDTM metadata as templates. So Formedix builds your datasets using the CDISC SDTM rules. The templated metadata is then extended using the selected CDISC NCI Controlled terms, and any supplemental qualifiers, value level metadata etc. is added.

Built in SDTM compliance
The FDA and PMDA publish compliance rules for clinical data submissions, including SDTM. The output must ultimately be compared against the rules.  And any deviations must be eliminated or fully documented. By building in e.g. SDTM compliance at the start of the process, you maximise compliance throughout the process. Key factors such as correct use of controlled terms must be built into the EDC CRF’s and SDTM conversion process. This includes EDC edit check programming and data management checks programmed to highlight data issues early.

Quicker eCRF design 
With Formedix metadata management tools, you can quickly build and publish case report forms (eCRFs) for clinical review. As the visual elements (questions, radio buttons, controlled terms) are captured along with the EDC database build specification (variable names, question settings, edit checks etc), an auto-generated specification is used for both the eCRF review and the EDC deployment. So you don’t need to check the EDC CRF’s against the eCRF specifications. They’re loaded automatically. This also means that any changes can be reflected in the review/build eCRF immediately. There’s no delay. You don’t need to create word specifications, for example, or manually make screenshots in the EDC.

WHAT’S YOUR STORY?

Tell us what you’re trying to do, and we’ll show you how we can help.

A QUICKER SDTM DATASET PROCESS

Each SDTM dataset starts as a specification in the Formedix platform. Our dataset design tools contain the CDISC SDTM metadata as templates. So Formedix builds your datasets using the CDISC SDTM rules. The templated metadata is then extended using the selected CDISC NCI controlled terms, and any supplemental qualifiers, value level metadata etc. is added.

This specification document forms both the guidance for programming teams, and also the Define-XML metadata for the dataset deliverable. The dataset specification is saved in Formedix, alongside the EDC build documents. This gives a central place for all your study metadata. Once the basic SDTM dataset structure is agreed, additional programmer instructions are added to each variable, domain etc. within the electronic specification. Any updates or clarifications are immediately captured in Formedix, and the software generated programmer specifications (e.g. excel sheets) are automatically updated. And the same metadata is used for the submission Define-XML, which is automatically generated.

The SDTM Define-XML is independent of the clinical datasets (and data programmer). Therefore it can be used as a benchmark to check the dataset content against, to ensure compliance with the CDISC SDTM standard.

Remember, if the Define-XML metadata is extracted from the clinical datasets, this is not suitable for use as a validation specification. Any errors in the datasets will just be recreated in the Define-XML, removing the ability to provide an independent quality check.

WHY WE'RE DIFFERENT

It takes a fraction of the time to set up your study in Formedix compared with other systems. Your typical 21 week study takes on average just 14 weeks. And the sooner you start your trials, the sooner you can get products to market (= faster ROI).

No other platform automatically builds your study in just about any EDC system – 7 to date – saving loads of time. Use your favourite, or even different EDCs for different studies.

Only we integrate 100% with Rave and InForm. So as well as seeing what something will look like before you build it, you can do edit checks and preview eCRFs too.

Unlike others, we keep pace with version changes in CDISC standards, so you’ll always be compliant.

Unlike others, you can truly reuse content and save time. No need to retype spreadsheet content for example. Simply reuse content from 1 study to another, and even across multiple EDC systems.

Ours is the only fully integrated clinical meta data repository out there. There’s other MDRs, but they’re like disconnected libraries. We’ve put everything in 1 place, where your content is truly interconnected.

We’re the only commercially available off-the-shelf clinical MDR. Straight out the box and off you go – we don’t have to custom build it for you from scratch.

Some companies don’t improve or expand their platform. We do, constantly. We’re always working on new stuff, and it’s based on your feedback.

SOME OF THE ORGANIZATIONS USING FORMEDIX

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Testimonials

Easily manage study changes with Formedix
If SDTM conversion is done before first patient enrolment, as a study progresses, inevitably there will be changes. And these changes will need to be made in the EDC system. This can be difficult. The programming team can’t easily track changes within the EDC system. Or easily quantify the impact of a change.

The Formedix platform stores the EDC design. So when an update is made, the SDTM programming team can clearly see any changes in Formedix – without even going into the EDC system. You can then compare the EDC clinical dataset specification against the updated versions to see the impact on SDTM programming. That means you can make adjustments during the eCRF update process – rather than after EDC deployment when data collection is already underway.

Detect and fix errors early on
As clinical data is entered, there will naturally be errors or incomplete information in the EDC. If SDTM programming is complete, periodic EDC data extracts can be converted into interim SDTM datasets, and validation done using the standard tools for FDA submission. These results can then be fed back to study data managers, and errors can be noted and corrected early. This typically reduces the burden of ‘data cleansing’ query resolution prior to database lock.

From this process, a ‘Reviewers Guide’ document can be created. This documents any deviations from the SDTM/FDA rules in detail as the data is collected. This ensures that all details are recorded for each issue.

VALUES THAT DRIVE US

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PASSION

We love what we do, love our community, and seeing the difference we make for people in the industry.

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INNOVATION

We’re always adding new stuff – mostly from your feedback. And our product road map promises lots more features to come.

INTEGRITY

You need us to be honest and clear, and that’s exactly how we are. We do what we say, and if we can’t do something, we’ll tell you.

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COLLABORATION

We genuinely care about you succeeding, and we’re on your side – think of us as an extension of your team.

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ADDED VALUE

We get on with things and get them done, no messing. And we’re fast, so you get more done, faster, and get a quick ROI.

METADATA REPOSITORY & STUDY AUTOMATION TOOLS

GOT A PROJECT IN MIND

Design, build and manage your metadata. All in 1 place.