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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 standardized 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

Discover Define-XML.   PharmaSUG 2014 – Paper DS01 Discover Define-XML Mark Wheeldon and Kevin Burges, Formedix, Burlington, MA.   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 Head of Product Management, Formedix.   ABSTRACT The Food and Drug Administration (FDA) recently announced a meeting, “Regulatory New Drug

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