How does integration work in Formedix?

Formedix integrates with EDCs that include Medidata Rave, Oracle InForm, XClinical Marvin, OmniComm TrialMaster, OpenClinica, Parexel DataLabs and Mi-Co Mi-Forms. Your internal system will be able to communicate with Formedix too. You won’t need to login to Formedix to manually upload your data. You can do this from your own system – our API automates the upload, conversion, and download of datasets.

An extension of your team

Q: What are the benefits of using professional services?

Our Professional Services team know the Formedix platform inside out. They are experts in our end-to-end system. So if you need help, or need to save time, our team can step in and get the job done. We also have over 19 years experience of CDISC standards. We’re currently part of the CDISC XML technical team and have been involved with CDISC ODM and Define. So we can help with that too!

Q: How does Formedix help me comply with CDISC standards?

The Formedix platform is built on CDISC compliant templates. So when you design CRFs and build your study in Formedix, you’ll automatically comply with the latest CDISC and NCI standards. If you’re importing existing content into Formedix, our CDISC validation tools flag up any issues and help you get them fixed!

Our services team is here to support you, or help you get the job done, pronto!

Clinical Trial Support Services

Our clinical trial support services team are specialists in the ryze platform. And you can benefit from their expertise too. They’re here to guide and support you when using ryze, aswell as provide additional services when needed.

Perhaps you’ve got a deadline. Or there’s a labour intensive task you don’t want your team tied up with. Maybe you’re close to submission and just want everything in the right format ready to go. Whatever the reason, our clinical trial support service department are here to help.

For example, we can help with all your submission deliverables. If you need CRF designs, annotated CRFs, SDTM conversions, define.xml, or define.pdf files for instance – just ask. Even get us to do your study data reviewers guide.

Think of us as an extension of your team. Remember, we’re on your side and it’s our job to help you succeed. So if you need us, we’re here. If you’ve got something in mind, get in touch. Once we know what you’re looking for, we can let you know the costs.

Some of the stuff we can do for you

Annotated CRFs

Define-xml

Define-PDF

SDTM Conversion

SDTM Automation

Study data reviewers guide

STDM Annotated CRFs

Effortless CDISC compliance

We manage your CDISC compliance. So you don’t have to.

Don’t worry about meeting the latest FDA data standards. ryze supports all versions of CDISC standards. And we keep ryze updated in line with CDISC and NCI standards. That way your study designs and datasets are always regulatory compliant.

As one of the first CDISC members back in 2001, you can rely on our deep rooted knowledge of all things CDISC. We’re members of the CDISC Data Exchange Standards team. As such we’ve been involved in developing many key features in CDISC ODM and Define models. This makes us well placed to give real-world, practical CDISC training. See our CDISC membership certificate for the year 2020-2021. Click below to find out more.

Got an urgent request?

If you need something turned around pretty quick, we can usually help with that too. For example, you might be close to submitting your study, but you need your deliverables sorting. No probs. We can create your define.xml or define.pdf files. And we can get these done pretty fast. If you’ve got something in mind, get in touch with the details and your timescales. Then we can send you a quote for our Professional Services team to do the work.

Testimonials

A structured approach for successful implementation

For the best possible start, we recommend a structured approach to project rollout. This will put you in the strongest position for a fast and efficient implementation. Our Professional Services department has worked with many organizations, based on this proven implementation plan:

Phase 1 - Planning

First, we analyze your existing content, processes and systems. Then we produce a detailed action plan that identifies key project requirements, and how any gaps will be addressed. Specifically, our action plan will:

Review your standards, and identify any missing content to be added. Then assess how your standards can be imported into ryze.
Analyze your governance processes, including naming conventions, workflows, EDC design and build, and dataset mapping and conversion. Define how new efficient processes will be implemented.
Identify requirements for any custom plug-ins (including importers, exporters, visualizations, validator rules and additional properties) or system integrations via APIs.

Phase 2 – Preparation

Next, we execute your detailed action plan. We prepare your MDR with all the necessary content. Then configure everything for your organization. Specifically, our Professional Services department will:

Set up your custom plug-ins.
Configure the ryze API to provide full integration with your existing systems (e.g. adding calls and file types).
Configure Single-Sign-On (SSO), proving user authentication between your existing systems and ryze.
Import your existing standards into the MDR, converting content as needed.
Work with your experts to create missing standards identified in the action plan.
Provide product and process training to help your team become experts on the ryze platform.
Run a two week on-site Proof of Concept (POC) study. Then update the action report to reflect lessons learnt.
Implement changes to content and processes as identified in the updated action plan report.

Phase 3 – Implementation

All the preparation is done. Now you’re ready for implementation. Specifically, you will:

Go live with a test platform, before full rollout of your production platform.
Be given refresher training via WebEx.
Have access to our e-learning courses, with accreditations on completion.
Receive our validation documentation to help with your own testing.

Organizations using our clinical trial software

Why we're different

It takes a fraction of the time to set up your study in ryze 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 potentially launch products (= 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 Clinical One. 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.

Unlike others, you can truly reuse content and save time. No need to retype spreadsheet contents for example. Simply reuse content from 1 study to another, and even across multiple EDC systems.

Ours is the only fully integrated clinical metadata 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.

Values that drive us

Passion

We love what we do, love our community, and seeing the difference we make for people in the industry.

Innovation

We’re always adding new stuff – mostly from your feedback. And our product road map promises lots more features to come.

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.

Collaboration

We genuinely care about you succeeding, and we’re on your side – think of us as an extension of your team.

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.

FAQs

What can Professional Services help with?

Examples of the sorts of things we’ve helped other companies with are importing standards and studies, creating CRFs, annotations, EDC builds, mapping and converting datasets, and define.xml. Whatever you need help with, our Professional Services team are here for you. See us as an extension of your team!

What are the benefits of using Professional Services?

Our Professional Services team know the ryze platform inside out. They are experts in our end-to-end system. So if you need help, or need to save time, our team can step in and get the job done. We also have over 19 years of experience of CDISC standards. We’re currently part of the CDISC XML technical team and have been involved with CDISC ODM and Define. So we can help with that too!

How much does Professional Services cost?

Let us know if you’ve got something in mind you want help with. Once we know what you’re looking for, we can let you know the costs.

How does ryze help me comply with CDISC standards?

The ryze platform is built on CDISC compliant templates. So when you design CRFs and build your study in Formedix, you’ll automatically comply with the latest CDISC and NCI standards. If you’re importing existing content into ryze, our CDISC validation tools flag up any issues and help you get them fixed!

How does integration work in ryze?

ryze integrates with EDCs that include Medidata Rave, Oracle InForm, XClinical Marvin, OmniComm TrialMaster, OpenClinica, Parexel DataLabs and Mi-Co Mi-Forms. Your internal system will be able to communicate with ryze too. You won’t need to login to Formedix to manually upload your data. You can do this from your own system – our API automates the upload, conversion, and download of datasets.

Got a job in mind?

Tell us the job, and we can advise the cost for our Professional Services team to do it for you.

An extension of your team