EASILY MANAGE & REUSE STANDARDS WITH OUR CLINICAL METADATA REPOSITORY

Automatically align with CDISC standards, with our off-the-shelf MDR.

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SAVE TIME & BOOST COMPLIANCE BY EFFECTIVELY MANAGING STANDARDS & CLINICAL METADATA

Formedix makes it really easy to manage your clinical metadata. Rather than searching for standards and study content in different files and spreadsheets, easily find everything in your clinical metadata repository. All your standards are in 1 place, for all your teams to see. It’s like having a really clever library!

Need to update your standards over time? Make changes with full traceability in Formedix. Track amends and see how your study differs from your standards – in 1 place, with 1 click! And because your standards go through quality approvals in Formedix, you know that you’re consistently using approved content.

Probably your biggest benefit is time saved. Because everything is in 1 place. It’s easy to find, use, and reuse.  There’s no need to redesign CRFs, edit checks, terminologies, and mappings for example every time.  Design once and reuse content across your studies and standards – even across different EDCs.

WHY USE THE FORMEDIX CLINICAL METADATA REPOSITORY?

INSTANTLY FIND EVERYTHING IN 1 PLACE

Find, manage and maintain standards in 1 central library. Rather than trying to find content and juggle spreadsheets – get at the content you need, super-fast.

BUILD STUDIES FASTER

You save so much time by reusing standardized content. As a result, it takes far less time for you to build a study, making it possible to get your submission in much faster.

EASILY KEEP TRACK OF CHANGES

There’s full traceability in Formedix. So you can see where a standard is used in studies, and any changes made to that standard over time. You can also check how a study differs from a standard in 1 click.

SAVE TIME BY REUSING CONTENT

Reuse assets from one study to another study – even across different EDCs. Reuse CRFs, standards, edit checks, mappings… No need to re-type stuff, so you save loads of time.

IMPROVE QUALITY & CONSISTENCY

Easily update and improve your standards in Formedix over time. And because of in-built quality processes, you can be sure that you’re always using the correct version of a standard, and being consistent across studies.

EASILY SHARE CONTENT AND COLLABORATE

Share content and work together from anywhere.  The Formedix clinical metadata repository keeps everything in 1 place, allowing teams to work more effectively and efficiently.

What can I do with Formedix?

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INTEGRATIONS

Do you work with any of these standards or systems? Formedix integrates with all of these, and can look at others if that’s what you need:

CDISC ODM, Define-XML, Analysis Results Metadata and Dataset-XML file format standards

CDISC SDTM, ADaM, SEND content standards

CDISC SHARE

SAS Transport v5 (XPT)

PDF

Excel

HTML

EDCs including Medidata RaveOracle InFormOmniComm TrialMasterXClinical MarvinOpenClinicaPAREXEL DataLabs and Mi-Co Mi-Forms

EDC SYSTEMS WE INTEGRATE WITH

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instead of 1,484 EDC labor hours

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instead of 486 SDTM labor hours

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weeks instead of 20 for EDC go-live

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weeks instead of 8 to see SDTM data

HOW TO BUILD STUDIES FROM STANDARDS

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You can quickly and easily build a study from a set of standards. First, create and approve your organizational standards in line with your internal processes.

Select your forms and related datasets from your standards. All related metadata, such as edit checks and mappings, is brought in automatically with your standards. Add any relevant protocol information – such as the visit schedule, custom edit checks, or custom mappings.

Then use our visualization tool to see what your CRFs look like in your chosen EDC system.

Once you’re done, you can carry out validation checks to make sure your study doesn’t have any errors, or is missing any metadata.

You can export it to your chosen EDC system, confident that it will work – you know the study is exactly as you designed! You can also create your source Define.xml and ensure that it meets the various regulatory requirements to help you achieve hassle free submission. Mappings are part of the study design, so you can generate initial downstream datasets. That means you don’t need to program the data conversion for your study!

START SAVING TIME WITH FORMEDIX

Find, share, and maintain your standards. All in 1 place.

WHAT ARE STANDARDS & HOW ARE THEY USED?

A standard is simply a group of related assets such as a forms, edit checks, datasets, mappings and terminologies. Your company can decide how best to group assets, for example, a standard could contain a Medical History form and a Medical History dataset or, it could contain multiple forms or multiple datasets.

You can design and refine standards according to your company’s governance process. Once approved, it becomes an organizational standard. If assets are standardized across the clinical lifecycle, you can be certain that data collection is consistent and valid, right through to submission.

Your approved standards can be reused. That means you only need to create them once! Study setup time is dramatically reduced by importing standard metadata from one location to another. So your process is very efficient as the content has already been tested and validated. Mapping to downstream systems is consistent, and there’s now a much smaller chance of mistakes happening.

SOME OF THE ORGANIZATIONS USING FORMEDIX

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Testimonials

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.

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.

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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.

DATA QUALITY & REGULATORY COMPLIANCE

Formedix has developed standards management libraries for leading life science organizations. And not just regular standards libraries or repositories.  We’re talking about standards libraries specifically optimized for clinical trials – to help deliver clinical trials as quickly and efficiently as possible.

You can define and validate your clinical metadata upfront in a standards library. This means you can control your metadata right from the outset. And in the end you’ll be able to improve consistency and data quality.

Formedix supports the latest industry standards such as CDISC SDTM, ADaM and Define-XML. So you can relax knowing that your studies meet the requirements of regulators such as the FDA, PMDA and EMA.

WHY USE STANDARDS?

DESIGN STUDIES FASTER

Formedix lets you import content from standards or existing studies, and make use of eCRF designs in Medidata Rave and Oracle InForm for example. Just move content from one location to another as you like.

You can see EDC specific CRF designs, and instantly make EDC build files for many different EDCs. All you do is switch on a plugin! You can also create detailed specifications and generate annotated CRFs in 1 click.

REUSE METADATA

You can reuse study designs again and again. So once they’re designed that’s it! With standardized study designs you can build studies fast, knowing they’re consistent and correct. Data quality is increased as there’s less chance of collecting the wrong data, or collecting too much data.

IMPACT ANALYSIS

You can evaluate the impact of any changes you want to make. Formedix shows you all  the associated standards and standard assets that may also need to be updated. Read more about impact analysis.

EASY SEARCHING

Formedix has a user friendly interface with a search function that lets you search across all your standards quickly and easily. There is no longer any need to trawl through different documents, stored in different locations.

TRACEABILITY

Traceability is becoming increasingly important during the lifecycle process allowing transparency between team members. Formedix allows you to easily see a full and detailed history of a standard – a single version of truth! If any questions come up about a particular standard, they can be quickly and easily answered!

GOVERNANCE

You can set up a lifecycle for your standards to transition through according to your company’s governance process. By promoting good practice you can increase the quality and consistency of the data you gather. Read about the metadata lifecycle.

Governance and change is key to the evolution of your organizational standards to make them more robust which leads to safer, more effective clinical trials.

METADATA REPOSITORY & STUDY AUTOMATION TOOLS

EVERYTHING YOU NEED IN 1 PLACE

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