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Gen up on the how’s, what’s and whys of clinical metadata management.

SDTM and LOINC Codes

What is a LOINC Code? Firstly, LOINC provides a unique identifier for each medical observation – such as lab test. It also provides additional information, such as standardised specimen type, category

CDASH to SDTM Mapping Challenges

Mapping CDASH to SDTM Learn about the complex processes involved in the CDASH to SDTM mapping procedure with Ed Chappell (Formedix) and Neil Vivian (OmniComm Systems) in this presentation. Industry experts Ed

Saving costs by adopting SDTM standards

Cost-effective adoption of SDTM standards Ed Chappell discusses the cost-effective adoption of the SDTM standard throughout the end-to-end clinical trial process. You can download Ed Chappell’s (Consultancy Team Leader) presentation from OmniComm’s

The many uses of SDTM define.xml

From study design to submission   Check out Mark Wheeldon’s presentation on the many and varied uses of SDTM define.xml from the PhUSE London SDE in May 2015. You can watch Mark Wheeldon’s

Designing Submission Datasets using Define-XML

PharmaSUG 2014 – Paper DS01 Discover Define-XML Mark Wheeldon and Kevin Burges, Formedix, Burlington, MA Discover Define-XML Abstract Previously, Define.pdf was used as a submission deliverable to enable FDA reviewers to understand the content of

How to implement CDASH standards

CDASH standards in a nutshell Check out Formedix CEO Mark Wheeldon’s presentation from the September 2013 New Jersey CDISC User Group meeting – held in Merck’s Summit campus – as he

FDA Study Data Exchange Standards

WHY ADOPT CDISC? SOLUTIONS FOR STUDY DATA EXCHANGE STANDARDS IN CLINICAL TRIALS KEVIN BURGES TECHNICAL STANDARDS DIRECTOR, FORMEDIX ABSTRACT The Food and Drug Administration (FDA) recently announced a meeting, “Regulatory New Drug Review: Solutions

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As you know, CRFs are a super important part of running a successful trial. You want to get clear, complete, consistent data, and a successful submission! So we put together something to help.😁 Check it out here https://t.co/sVvh15a6mO
#Formedix #crf #clinicaltrials

We’re working with a pharma based in the US and Europe to manage their metadata. Now they can bring EDC builds and SDTM conversions back in-house, share metadata with CROs, and use the Formedix API to integrate with their systems. Can we help you too? https://t.co/1ZCWUYnNkZ

Fancy having an easier life? Well, you can! Start automating your CRF annotations instead of doing them by hand 👍 Find out more at https://t.co/ZGq48i4vqy
#Formedix

We’re working with a west coast pharma so they can visualize and standardize eCRFs in various EDCs. No more mock-ups to do by hand! They can also use the built in review and approval processes for governance and easy management! Can we help you too? https://t.co/bnwaPob9F0

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