ANNOTATED CRFS, ZERO EFFORT

Formedix does the laborious stuff. So your team can crack on elsewhere.

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MAKE SDTM ANNOTATED CRFS, EFFORTLESSLY

Annotating CRFs (Case Report Forms) is an important, but almighty task. You need to manually create annotations for every single form. Then convert your forms into PDF. That’s a lot of time and resources. But you don’t need to do it the hard way…

Once your CRF designs are created in Formedix, you can easily annotate them – all in the same place. We simply use your metadata to make the annotations for you. Then just press a button to see what your CRF design looks like in PDF format. Easily make any changes. And instantly preview again until you’re done. Imagine how much time you could save, and how much more productive you could be! 

And remember, if you’re building studies from your standards library, you can reuse annotations. That’s even more time saved – with no effort at all!

WHAT'S IN IT FOR ME?

INSTANT SDTM ANNOTATIONS

Formedix annotates your forms, leaving you to simply push a button for your PDF. Why wait!

SAVE TIME BY REUSING CONTENT

Reuse annotations from one study to another study – even across multiple EDCs. There’s no need to re-type everything, so you save lots of time.

SUBMIT STUDIES FASTER

Because you instantly get your SDTM annotated CRFs in the right format, you can be ready to submit your study to the FDA much sooner.

YOU'RE IN CONTROL

If you want, add several annotations on a form or question. As well as links between fields and datasets, you could have annotations for different teams, or notes for reviewers. And if they need to be in a certain font, colour or format, that’s fine. You decide how they look.

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.

What can I do with Formedix?

WHAT ARE ANNOTATED CRFS?

An annotated CRF is a blank form that contains annotations (or notes) next to each form question. Annotations show the location of data, along with related dataset names, and variable names within those datasets in the submission.

In other words, annotations describe where the data collected for each question is stored in the corresponding dataset. They show the origin of variables, and link between the fields on the form and the variables in the dataset.

Annotated CRFs are one of the mandatory deliverables for submission to the FDA for SDTM. Your SDTM annotations let the reviewer check metadata definitions, by tracing data that has come from the CRF. They also help promote standardization of data submitted in the industry.

SOME OF THE ORGANIZATIONS USING FORMEDIX

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Testimonials

WHY USE FORMEDIX FOR SDTM ANNOTATIONS?

Making SDTM annotated CRFs can be laborious and incredibly time consuming. Formedix makes it much easier to create annotated CRFs with minimal effort.

Gone are the days of manually creating annotated CRFs each time. Then having to verify that it matches the collected data. Once the data acquisition forms for your study have been defined upfront, you can add annotations in your SDTM.

Then it’s a simple push of a button to generate a regulatory compliant SDTM annotated CRF. It’s based on your original study design, so you know it’s right. That means no more rushing to manually create your annotated CRF when pulling together your submission!

When you have end-to-end standards, your data acquisition forms are aligned with your downstream datasets. When creating a study from your standards, everything comes along. Your forms, terminologies, edit checks, datasets, and the annotations that drive the annotated CRF.

In other words, once you’ve created your standard annotated CRFs, you can reuse them from study to study.

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. That includes still supporting older versions of standards too.

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.

START SAVING TIME

With your annotated CRFs as instant PDFs.

HOW WE MAKE ANNOTATED CRFS LESS OF A CHORE

One of the main benefits of generating annotated CRFs using Formedix, is that you have detailed control over your form layouts. You decide on the font, display format, placement, color and type of annotations.

Have many types of annotation?
You can use annotations for more than mapping between fields on a form to variables in a dataset. You can create annotation notes next to fields for SAS Programmers, Data Management and reviewers.

Even provide other useful information, such as indicating which fields are required or hidden. Simply tailor annotations to fit how you want to work!

This is an example of an annotated Rave CRF. And here’s an example of an annotated paper CRF.

Previewing annotations

Why painstakingly create manual annotations on PDF’s, one form at a time. Let Formedix do it for you and save time and resources to focus elsewhere. Just switch on the plugin of your choice. Then set your annotation type, display format, and font. Next, set your SDTM annotations on each field. Now you’re now good to go! And you can easily preview what your annotations will look like, so you know they’re correct!

What about reusing annotations?

You can reuse your standards and studies – including annotations – so you don’t have to do them again! This helps you maintain consistency across studies, standards, and in your SDTM. It also reduces the margin for error.

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.

METADATA REPOSITORY & STUDY AUTOMATION TOOLS

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