When it comes to clinical trial submission, one of the most significant standards is the...
As you know, clinical trials are complex! Industry standards are now required for clinical trial submission. And that means even greater complexity, costs, resources, time and effort.
Is there a magic wand?
Well, not exactly. But the Formedix clinical metadata repository (MDR) comes close!
So what can it do? In a nutshell, it can help you save time, build studies faster, increase study quality and reduce costs.
How is this possible?
Take studies and standards for example. Ideally, you want to manage them all in 1 place. Right? The Formedix clinical metadata repository lets you do just that. It is really a fancy web platform for managing your clinical trial metadata.
Import your organisational standards straight from your database into your clinical MDR. Then you are ready to go! You have already saved a huge amount of time getting started.
Plus, now you will not spend time searching all over for files and spreadsheets. You can easily search across all the content in your clinical MDR. And your teams can work together like never before. No information gaps and no duplicated activities. You have got full transparency.
You can define your own role-based access if you want. What content you want to lock down and what you want to make available. You can set up different types of access to studies and standards. And for different individuals and teams. Whatever works best for your company.
Dealing with change is often a real headache. And if it is not done correctly, you risk regulatory non-compliance. So Formedix lets you create and manage change requests really easily. If one person makes a change, the content is locked down. No conflicts. And full traceability makes it easy to see what has been changed.
Impact analysis is built-in. This lets you see the impact of any changes before you make them. You can easily identify any content that needs to be updated in response to a change. Then, you will be in a position to decide if it is worth making the change or not.
Want to build studies faster?
Once your standardised content is in our clinical MDR, you can reuse it across all your standards and studies. As often as you like. That saves you from retyping them each time.
And because your content has been approved and standardised, you know it is correct. This helps you keep data nice and consistent and maintains compliance across studies. That is a big tick in the quality box, as well as saving even more time.
What about EDC build?
Formedix lets you build, preview and validate studies for seven leading EDC systems including Rave and InForm.
The best thing is, you can preview exactly what your CRFs and annotations will look like in your EDC – before you have built your study! When you arere ready to export, you can be confident it is going to be as expected.
Using Rave EDC?
Formedix fully integrates with Rave. That means you can import and export your studies directly to and from Rave! Again, this saves you a huge amount of time. A study that typically takes 21 weeks to build can take as little as 14 weeks with Formedix. That is the kind of time and resource-saving you are looking at.
Want to make things even easier?
Our API lets your internal system automatically communicate with the Formedix platform. For example, you could automatically upload and download datasets between Formedix and your in-house database. How efficient is that!
So your clinical trial design, build and submission can be so much faster than before. The time and resources you save mean potential cost savings too.
The good thing is, our clinical metadata repository is off-the-shelf. So you can get up and running straight away. You do not need to wait for us to build it from scratch. But likewise, if you need any customisations, our in-house development team can make it happen.
And if you need a helping hand along the way?
No problem. Our Professional Services team is here to support you. Think of them as part of your wider team. We understand a lot of the daily pressures and difficulties you go through. After all, we have been in the business for 20 years. That is a lot of time spent getting to know what you are up against. And that is how we are able to help, with solutions that target and solve those chronic pain points!
For more information, please fill out the enquiry form attached to this page.
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