It’s off-the-shelf, you can start right away!
Imagine if all your study content – standards, forms, datasets, mappings… were in 1 place. And they were all interconnected. Everything from eCRFs to submission deliverables. No matter where they were, your teams could manage standards and studies, share and reuse content – even across different EDCs and e-clinical systems. That’s Formedix. The all-in-1 fully integrated clinical metadata repository. And you can start now. It’s ready out-the-box – no long and complex implementation. See 4 important aspects to think about when considering an MDR.
Crating clinical study builds from scratch is far quicker and easier with our clinical metadata repository. You’ve got pre-approved, consistent content in your MDR. And this can be reused forever more across your studies and standards. Instead of starting out with nothing, you’ve got an entire library of content ready to go!
Because your content is in 1 place, you don’t need to go hunting for it. Everything held in your studies and standards is right there for all to see. Different teams can get at the data they need, and easily share and approve content. Plus, you save acres of time reusing content. There’s no need to retype it every time.
Increase the quality of studies by reusing content from your standards library in our clinical metadata repository. You’re not constantly retyping stuff, so there’s no manual errors. And because you’re using standardized content, you know it’s already been approved internally.
By managing standards and building your study libraries in Formedix, you really cut clinical study build costs. You get started so much faster because most of your content is there in your clinical metadata repository. And if the data you want isn’t there, just import it into your Formedix library from your EDC, e-clinical or internal systems.
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.
Find out more about change requests.
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 clinical MDR.
How our clinical metadata repository makes things easier
You can create and manage your organizational standards in your clinical MDR. This includes importing content from your EDC, e-clinical database or other external systems. This helps to increase your data quality, and decreases downstream costs. By creating consistent forms and datasets, 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.
You can quickly and easily build a study from a set of standards. First, create and approve your standards within a company defined governance workflow. You have complete control over your study designs.
Choose your forms and related datasets from your standards. All related metadata, such as edit checks and mappings, is brought in automatically with your standards, so you know they’re correct.
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 does not contain 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 generate your source Define.xml and ensure it meets the various regulatory requirements to help you achieve a hassle free submission. Mappings are part of the study design so you can generate initial downstream datasets – you don’t need to program the data conversion for your study!
Formedix has been a valuable resource and their services have added value to our platform and data management capabilities. ...
An off-the-shelf solution doesn’t always meet your needs. No problem. Our in-house development team has had a lot of practice at this. We can customize our clinical metadata repository and clinical trial automation software to work for you. Best to get in touch and tell us all about it.
The pharmaceutical industry has been changing over the last 10 to 20 years. Things are moving from paper based clinical trials, to electronic data capture based clinical trials. There’s also a larger number of sponsors, trials and data than ever before to deal with. Industry standards have become an absolute necessity for governing and managing clinical trials. These are now required as part of the submission to regulatory bodies, such as the FDA.
As a result, clinical trials are facing increasing challenges, and spiralling costs. A clinical metadata repository (or MDR for short) helps to address these challenges. Having a central web platform for managing standards and clinical metadata saves time and reduces manual labour. This ultimately helps reduce the cost of setting up and managing clinical studies.
Change during the clinical trial process is a painful, unavoidable reality. It is also essential for quality assurance. And we all know that change control that isn’t properly managed results in regulatory non-compliance.
Formedix takes away all that pain and allows you to manage changes confidently, knowing that nothing has been missed. Change request details are easy to find and review in Formedix. You can even download a summary of all change requests.
We give you complete flexibility. You can customize your own change request templates – each with their own workflow – which you can configure to suit your needs. Find out more about change requests.
Impact analysis tools in Formedix help you clearly see the impact of any proposed changes. You can also identify any associated assets that may need to be updated. Read more about impact analysis.
You can run reports that show the differences between your studies and organizational standards. And you can compare a study to your standards, or other studies, or previous versions. That way you have complete control over change.
We love what we do, love our community, and seeing the difference we make for people in the industry.
We’re always adding new stuff – mostly from your feedback. And our product road map promises lots more features to come.
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.
We genuinely care about you succeeding, and we’re on your side – think of us as an extension of your team.
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.
Everyone knows that people achieve more working together in teams than they do alone. Our clinical metadata repository gives you total transparency throughout the end to end process. And this helps to improve the overall quality of your clinical trial data.
Formedix lets you set up role-based access to standards and studies. Standards can be available to all, or locked down to specific teams. Studies can be open to all, or restricted to a smaller study team. Plus, individual teams can have different access rights. For example, data managers may be able to edit forms and view datasets. Biostatisticians may be able to view forms and edit datasets and mappings. It’s really up to you how you want it to work!