Author: Steven Benham
Clinical study build can be a complex process. In order to be successful, a trial must comply with CDISC standards before it can be submitted. This requires a thorough understanding of the standards themselves and means that companies need to allocate time and resources to ensure compliance throughout study design and build.
A clinical metadata repository (MDR) can help to make this process a whole lot easier and, ultimately, get life changing medicines to market sooner.
ryze is one example of clinical trial automation software that can help users build studies faster and increase study quality, all while saving time and cost.
Save time with clinical trial automation
Imagine if you could manage studies and standards from a single platform. Sounds too good to be true, right? But a clinical MDR lets you do just that. What’s more, a study that typically takes 21 weeks to build can take as little as 6 weeks with ryze. How? Because with automated features and all your data in one place, you can save time usually spent on manual work.
- Stay on track with CDISC and NCI standards - CDISC aligned templates are built into the ryze framework. That makes it easier to comply with industry standards required by the FDA, such as SDTM, ADaM, SEND, and Define-XML.
- Automatically convert datasets to SDTM - See your source SDTM datasets before collecting any patient data. That’s a big head start on SDTM dataset design. ryze ‘predicts’ the raw structure of datasets. So you can start your SDTM mappings early too. Then, it’s just one click in ryze to do your SDTM conversion.
- Easily integrate with other systems - If the process of switching to an MDR sounds laborious – don’t worry! You can import your organizational standards straight from your database. Our API also lets ryze communicate with your internal systems, allowing you to automatically upload/download datasets between ryze and your in-house database.
There are other ways you can save time too, because when your metadata is in our platform, you can reuse your standards and studies as often as you need to. That way you don’t need to retype them every time.
With all your metadata in one place, you’ll no longer have to search all over your files for documents and spreadsheets. Instead, you’ll be able to easily search across all the content in your MDR.
And because ryze is cloud-based there’s zero install – it’s ready to go when you are!
Increase study quality
It’s not just about speeding up the process – data integrity and standards compliance are crucial to the success of a clinical trial. With ryze, study quality is all taken care of.
Here’s just some of the ways ryze achieves this:
- Define your own role-based access - Decide what content you want to lock down and what you want to make available. You can also set up different levels of access to studies and standards by individuals and teams. Whatever works best for your organization.
- Deal with change requests, without the headache! - If change requests are not applied correctly, you risk regulatory non-compliance. A clinical MDR lets you create and manage change requests really easily. If one person makes a change, the content is locked down, ensuring no conflicts. And full traceability makes it easy to see what’s been changed and by who.
- See the impact of changes right away - Impact analysis is built-in with ryze. This lets you easily identify any content that needs to be updated in response to a change.
- Validate studies for your chosen EDC - You can build, preview, and validate studies for leading EDC systems in ryze. That includes Rave and Clinical One. Formedix fully integrates with Rave EDC, which means you can save time by importing and exporting your studies directly to and from Rave.
- Preview your CRFs and annotations - before you’ve built your study! See exactly what they’ll look like for your chosen EDC in advance, so that when you’re ready to export, you can be confident it’s going to look as expected. Read more about CRFs in our blog on everything you need to know about CRFs, or discover why you should switch to automated CRF annotations.
- Organize workload across teams - No information gaps, no duplicated activities, and full transparency means that your teams can work together more efficiently.
- Reuse standards and studies - Because your content is standardized (in other words, it’s already been approved) you can reuse it, confident that it’s accurate. This helps you keep data consistent, and maintains compliance across studies. That’s a big tick in the quality box!
You’ll be supported every step of the way…
Our Professional Services team is here to help – in the beginning and after you come on board! The industry is ever changing and so are your needs, so we listen to customer feedback and use it to continuously improve our platform.
Think of us as a part of your wider team, who have spent 20 years getting to know what you’re up against.
Want to see ryze in action?
Clinical trial design, build, and submission can be faster, more efficient, and more cost-effective with ryze - the only all-in-one, cloud-based, clinical MDR. But don’t take our word for it! You can request a demo now or email us to hear from an expert.