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CDISC Training And Professional Support

Whether it’s CDISC training, professional services, or just a bit of support you need, we can help.

SUPPORT, TRAINING & PROFESSIONAL SERVICES

Once you start working with Formedix, there’s lots of things we can do to make your day job much easier! You’ll get a dedicated account manager – a member of our Professional Services department. Their job is to help you achieve your objectives, and make sure that everything runs swimmingly with Formedix. This is someone you can really rely on, for lots of things. This includes clinical trial automation services and day-to-day support using the platform. And if you need any training or professional services, your account manager can provide this too.

TRAINING SERVICES

Your account manager can help with any training requirements you may have. Whether it’s product training on the Formedix platform or practical CDISC training, we have the knowledge to help.

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PROFESSIONAL SERVICES

If there’s an element of the study build process you want us to do, we provide clinical trial automation services – including SDTM conversion, SDTM automation, SDTM define.xml, adam define.xml, annotated CRFs or define.xml files – we can help.

EFFORTLESS CDISC COMPLIANCE

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

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Don’t worry about meeting the latest FDA data standards. Formedix supports all versions of CDISC standards. And we keep our platform 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 XML technical 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.

HOW WE SUPPORT YOU

Our Professional Services department is also here to support you with the Formedix platform. As soon as you start working with us, you’ll have your own account manager. Think of them as someone in Formedix fighting your corner, representing the needs of your company. It’s their job to help you achieve your goals, and solve any problems.

Product support
You can also turn to your account manager for product support. Either by phone, email or online chat – whichever works for you. Our standard support hours are Monday-Friday, 9am to 5.30pm GMT. But we offer wider support packages, for example to cover different time zones, if needed. And remember, we’re not like a call centre where you’ll be stuck in a queue for ages. You’ll find that we’re easy to get hold of, and really responsive to your needs.

CDISC expertise
As well as Formedix product expertise, our Professional Services team know all about CDISC industry standards. We were one of the first ever CDISC members over 18 years ago. And we’re still active members of the CDISC XML team. So we have to be on top of the latest CDISDC standards, and keep our platform updated too. Our team regularly speak at industry events, and we offer training in both CDISC standards and the Formedix platform. Find out more about our training services>>

NEED SOMETHING TURNED AROUND REAL FAST?

If you’re rushing to get submission deliverables ready, for example, we can turn things around pretty quick. Need your Define.PDF or Define.XML files? Contact us and we’ll send you a quote for our Professional Services team to do it for you.

SOME OF THE ORGANIZATIONS USING FORMEDIX

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Testimonials

Frequently Asked Questions

Can I start using the Formedix clinical trial software straight away?

Yes, it’s super quick and easy to get started! Start by importing your existing studies and standards. Then, you’ll have a library of content that easy to find, reuse, edit and share.

What training can I get?

We provide online and in person training on the Formedix platform. We also provide CDISC standards training. We can tailor both types of training to suit your needs. All you need to do is discuss your training requirements with your Account Manager, and we’ll take it from there.

How do Professional Services help?

Professional Services can help with anything you want to do in our platform. Examples include SDTM conversion, SDTM and ADaM datasets, SDTM define.xml, CRF design, and EDC build. Just let us know how we can help.

What CDISC standards are required for regulatory submission?

CDISC SDTM, ADaM, Define-XML and SEND. These different CDISC standards are required at different stages in clinical studies.

What are CDISC SDTM standards?

CDISC built SDTM to provide a standard way to organize and format data. This is to streamline the processes in collection, management, analysis and reporting of clinical trial data.

Will I have a dedicated Account Manager?

Yes. A member of our Professional Services team will be assigned as your Account Manager. They’ll be there to help you achieve your goals, keep communication open, and for day to day support. We would like you to think of your Account Manager as part of your team!

GOT A PROJECT IN MIND?

If you’d like any CDISC training sessions or help with professional services, get in touch and tell us what you’re looking for.