Tags: Clinical study build
Can clinical study build be a piece of cake?
It’s no exaggeration to say that it’s a helluva lot of work to get a clinical study ready for data collection! You’ve got to do all your CRF designs; keep up with protocol changes; add the annotations; make sure everything aligns with CDISC standards. And the list goes on, and on…
So what gives?
While we can’t help with changes to your protocol, we can help with pretty much everything else!
You can build content from scratch quickly in Formedix. Or you can import from standard libraries, or directly from Rave and InForm.
It’s one click to preview your annotated forms for the EDC of your choice. Plus you can validate your studies as you go. And once you’ve done all that, it’s only one click to build your study. It’s all validated and ready to export to your chosen EDC!
How quick is it to get up and running?
Well, it’s going to vary from organization to organization. But, we estimate that if it usually takes you 20 weeks to make a clinical study build, you can do it in as little as 4 weeks with Formedix. That’s a huge difference!
1 click clinical study build. Really?
It’s easy to see what CRF designs and annotations will look like in your chosen EDC system. Literally one click to preview is all it takes.
When everything’s all set up, one click and hey presto! Your study is built and ready for export!
Are you starting to see how much time you could save? Find out more about building and previewing your EDC study in Formedix.
Can study content be reused?
You can reuse your standardized study content. Just choose what you want to import into the Formedix clinical metadata repository platform. It could be the whole study, organizational standards that you want to manage. It could be forms, spreadsheets (including content), or even just some terminologies. It’s up to you! That way you have consistent, validated content. And you can reuse it as often as you like. If you want to read more about clinical metadata repositories, you can read Are Clinical MDRs bursting your brain? Here’s 4 important aspects to consider…
You can also reuse your edit checks. They can be a real pain and take quite a bit of time to set up. Because edit checks can be similar across studies, it makes sense to reuse them. Why make more work for yourself? All you have to do is import them, edit them to suit, and that’s you done!
What about integration with EDCs?
Formedix integrates with 7 leading EDC systems. Simply choose the one (or more than one!) that you want to build a study for. And you can even import studies from Rave and InForm into Formedix.
Before you build your study, you can check to see how your CRF designs will look in your EDC. You can get them looking perfect before you build your study!
Validation couldn’t be easier. By default Formedix automatically validates your study against CDISC ODM. After you’ve chosen your EDC, run the validation tool, and fix any errors. It’s quick and easy to do as you know exactly where to find them in your study.
Get your source define.xml
After setting up your clinical study, another benefit is that you can create your source define.xml. There’s no worries with it meeting regulatory requirements when you submit your study. It’s hassle-free! Mappings are part of the study design so you can also create downstream datasets. And you don’t have to program the data conversion for your study. That’s more time saved!
What about support?
We’re constantly expanding and enhancing our platform. So, you’ll always be on the right side of CDISC compliance. Plus, you’ll have a regular flow of new features that help you do even more things, quicker and easier. The bulk of our development is based on customer feedback. Just pass on your wish list and we’ll see what we can do!
If it’s an everyday helping hand you’re after, our Professional Services team is here to give technical support. However you want to get in touch, they’re available on the phone, email, chat, or social media. And if you want to train up your teams to become experts in Formedix, or CDISC standards, our training sessions are the answer.
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