With our clinical metadata repository & clinical trial automation software platform.
Did you know the FDA is making CDISC compliance mandatory for all submissions? How does your data stack up? The good news is, Formedix can help. Our platform is built on CDISC templates – compliance is enforced from study start to finish with the latest CDISC SDTM, CDISC ADaM, and NCI standards. No expertise needed. And with automatic processes, you’ll be able to save precious time, budget and resources.
Our platform has CDISC compliant templates letting you build studies in both current and previous versions of CDISC. Choose the relevant version of SDTM, ADaM and SEND standards and our templates guide you every step of the way. If you make a mistake, our validator tool will alert you instantly. You can even see reports showing changes to CDISC and NCI standards. Now you’ll be in a better position to win more trials from the NIH.
Formedix has automated processes to streamline studies from beginning to end. Less expertise is required for programming tasks. And you won’t need to spend money on expensive CDISC training courses. You’ll be able to make budget cuts allowing funding to stretch further than before.
Every stage in the clinical study build process is faster in our platform. Like CRF design, specifications, datasets, mappings, SDTM conversion and define.xml. And with CDISC expertise built in, you’ll save a ton of time. By saving time and resources, you’ll be much better placed to bid for more grants.
Because our platform is built on the latest CDISC standards, your study design and data automatically comply with FDA regulations. This helps to increase your chances of a successful, approved submission. And you’ll be in a better position to win more grants.
The Formedix platform incorporates a clinical metadata repository (MDR). Think of it as a central library where all your clinical metadata is held and managed. All of your content is fully connected, from eCRFs through to submission deliverables. You can easily find, review, reuse, and share content – including across different EDC and other external systems.
With our metadata repository, you can easily manage change, whilst also complying with regulatory standards. You benefit from a structured process that adheres to regulatory compliance. And this in turn reduces associated risk.
1 home for your metadata
Different departments can access studies and organizational standards in one place. You can assign work to specific individuals, and allow parallel review by multiple specified users. This gives greater transparency and enables better communication amongst your team. Global search functionality makes it quick and easy to find studies, standards, and assets in your metadata repository.
How our MDR makes things easier
You can create and manage your organizational standards in your metadata repository. This includes importing content from your EDC system, and from your e-clinical database or other external systems. This helps to increase your data quality, and decreases downstream costs. By creating consistent forms and datasets etc. it means that building studies from scratch is now quick and easy!
For studies and standards, you can include any related links. For example, you can link to a CDISC Therapeutic Area User Guide with instructions for how to use a CRF or dataset. You can also add any related files, such as the protocol or statistical analysis plan.
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 for your MDR clinical trials.
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.
We’re using the Formedix platform to design CDASH example CRFs for the CDISC CDASH-IG standards package. We can create, visualize, edit and approve eCRFs in the platform, then export them in ODM-XML to use in the CDISC Library and standards packages. Formedix is one of CDISC’s longest standing members. CDISC is keen to work with technology partners that help pharmaceutical organizations to adopt and keep pace with emerging CDISC standards.
Formedix has been a valuable resource and their services have added value to our platform and data management capabilities.
You can get started immediately. Our platform is off-the-shelf. Import your content and use our built in templates and validator tools to align with CDISC standards. By standardizing content, you can reuse it again and again across all your studies. That way it’s guaranteed to be higher quality and increases the chance of successful submission to the FDA.
Our platform automates many manual programming tasks that highly skilled, highly paid developers do. And because CDISC standards are built in, it means that a high level of expertise is not required. You can save training and staffing expenses, as well as a lot of time.
The FDA is making it mandatory for clinical trials run by academic institutions to comply with CDISC SDTM, ADaM, Define-XML and SEND standards.
Our SDTM mapping tools automatically create the specifications for you. No double coding needed. That means you get your SDTM dataset conversion in as little as 4 weeks – maybe even less.
Yes. When you create a study build in Formedix, it’s in ODM format. All you need to do is import it into the EDC of your choice. Formedix integrates directly with 7 leading EDCs including OpenClinica. So for example, you can import content directly from OpenClinica and see how your CRFs will look and work – in Formedix. Then, make any required changes and build your OpenClinica EDC in 1 click.
You can quickly and easily see all the specifications your teams need – in 1 click. See your CRFs as you design them in Formedix. See metadata specifications, visit structures, annotated CRFs, edit check specifications, and mapping specifications.