Want to reuse metadata content & build studies faster?

The ryze MDR platform incorporates a clinical metadata repository (MDR), or a cloud MDR! Think of it as a central library where all your clinical metadata is held and managed. All of your content is connected, from eCRFs through to submission deliverables. You can easily find, review, reuse, and share content – including across different EDC and other external systems.

1 home for your metadata
Different departments can access studies and organizational standards in one place for your MDR clinical trials. 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 metadata repository.

Easily manage changes
With ryze MDR automation platform, you can easily manage changes and consider impacts. You benefit from a structured process that adheres to regulatory compliance. And this, in turn, reduces associated risk. Find out more about change management in ryze.

How our metadata management tools make things easier
You can create and manage your organizational standards in your clinical metadata repository. 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.

ryze makes it really easy to manage your clinical metadata. Rather than searching for standards and study content in different files and spreadsheets, easily find everything in your clinical metadata repository. All your standards are in 1 place, for all your teams to see. It’s like having a really clever library!

Need to update your standards over time? Make changes with full traceability in ryze. Track amends and see how your study differs from your standards – in 1 place, with 1 click! And because your standards go through quality approvals in ryze, you know that you’re consistently using approved content for your MDR clinical trials.

Probably your biggest benefit is time saved. Because everything is in 1 place. It’s easy to find, use, and reuse.  There’s no need to redesign CRFs, edit checks, terminologies, and mappings for example every time.  Design once and reuse content across your studies and standards – even across different EDCs.

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!

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. Clinical data repository software helps to address these challenges. Here’s 4 important things to think about when considering a clinical metadata repository.

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. And using standards gives you plenty more benefits.

Design studies faster

ryze lets you import content from standards or existing studies, and make use of eCRF designs in Medidata Rave and Oracle InForm for example. Just move content from one location to another as you like.

You can see EDC specific CRF designs, and instantly make EDC build files for many different EDCs. All you do is switch on a plugin! You can also create detailed specifications and generate annotated CRFs in 1 click.

Reuse metadata

You can reuse study designs again and again. So once they’re designed that’s it! With standardized study designs, you can build studies fast, knowing they’re consistent and correct. Data quality is increased as there’s less chance of collecting the wrong data or collecting too much data.

Impact analysis

You can evaluate the impact of any changes you want to make. ryze shows you all the associated standards and standard assets that may also need to be updated. Read more about impact analysis.

Easy searching

ryze has a user friendly interface with a search function that lets you search across all your standards quickly and easily. There is no longer any need to trawl through different documents, stored in different locations.

Traceability

Traceability is becoming increasingly important during the lifecycle process allowing transparency between team members. ryze allows you to easily see a full and detailed history of a standard – a single version of truth! If any questions come up about a particular standard, they can be quickly and easily answered!

Governance

You can set up a lifecycle for your standards to transition through according to your company’s governance process. By promoting good practice you can increase the quality and consistency of the data you gather. Read about how the ryze metadata lifecycle works.

Governance and change is key to the evolution of your organizational standards to make them more robust which leads to safer, more effective clinical trials.

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.

ryze 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 ryze. 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 ryze 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.