Blog

Biomedical Concepts

Biomedical Concepts

The notion of biomedical concepts has been discussed within the CDISC community for almost 10 years now, with the most recent prominent appearance occurring during this April’s CDISC 360 project wrapup webinar. In this post we will examine

read more
Maintaining Information in Two Places

Maintaining Information in Two Places

We recently received a question about maintaining information in two places in case a digital protocol solution would have to coexist with a traditional Word authoring solution, in particular when amendments have to be incorporated. It’s a really good question and like with all good questions, the answer to it is “it depends”, and let me explain some of the dependencies.

read more
Nurocor Roadmap to Digital Data Flow

Nurocor Roadmap to Digital Data Flow

At Nurocor, we are reaching a tipping point in our product offering that can significantly transform clinical research from a paper based world to a digital protocol driven collaboration platform. It seems therefore a good place and time to look back at the road travelled, to take in the current landscape, and to put a mark on the map where we would like to be two to four years from now.

read more
When is an MDR not an MDR?

When is an MDR not an MDR?

There’s a standard for that! ISO 11179 is the standard for metadata registries and is something you should look out for when selecting a Metadata Repository (MDR) solution. Take a look at Frederik Malfait’s post on the importance of ISO 11179. An enterprise grade MDR will utilize an ISO 11179 metamodel to provide the capability to manage standards. The primary use case for an MDR within Clinical Development is managing the CDISC standards. It’s important to highlight that the ISO 11179

read more
Validated System Status

Validated System Status

“Nurocor, Inc. is pleased to announce that Nurocor MDR has achieved validated system status.” Huh? Right about now, you might be asking yourself “What is a validated system and why should I care?” However, those of you working in the pharmaceutical industry already know the answer to this question – you are well aware that the US Federal government mandates under its Code of Federal Regulations (CFR) Title 21 (Food and Drugs) that systems used to manage electronic records must be validated “…

read more
DATA STANDARDS – REQUIREMENT OR OPPORTUNITY

DATA STANDARDS – REQUIREMENT OR OPPORTUNITY

Data standards for clinical trials are a regulatory requirement which becomes an opportunity when enabled by technology. There are challenges though:

The first challenge centers around the management of data standards. The key insight here is to consistently treat data standards as metadata describing the actual data. How apt would it be to use an approved metadata standard to manage clinical

read more