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European Pharmaceutical Contractor

Degrees of Separation

 

What do a shopping centre and a data warehouse have in common? A shopping trip to buy clothes may seem completely different from trying to get data out of your electronic system, but similarities do exist. Have you ever spent time in a changing room unable to find the right shorts despite trying 20 different pairs? And now, think about your (clinical) data warehouse. How much effort do you spend attempting to get your data out of your system and mapping these data from (e)-clinical trials into Study Data Tabulation Model (SDTM), for example, to prepare them for the regulatory submission standard of today? Likewise, having experienced end of season sales, it is not a controlled environment for a data warehouse. Clearing out is necessary both in the real and the digital world, but ultimately you want to have the data stored safely in a controlled manner.

So how does the Biomedical Research Integrated Domain Group (BRIDG) relate to a data warehouse? BRIDG can be the overview map of your (clinical) data warehouse today or in the future. It identifies the relative location where you can access your data in a very organised and controlled environment. In fact, it is more than likely to be the foundation structure of your data warehouse. Why? Because it will be standardised across the industry (it is being submitted for ISO approval), not just a standard of an individual organisation.

Before I discuss the current situation and what is promised in the future, letís start with a little history.

PAST

The collaboration between Health Level 7 (HL7) and CDISC started in 2001. In 2003, CDISC started to develop the domain analysis model to harmonise their models with HL7. This BRIDG model is distinct from the other CDISC standards as it is a formal model of the shared semantics of regulated bio-medical research. The two major objectives for creating the BRIDG model were:

  • To provide a domain analysis model (DAM) for clinical research that harmonises all of the existing CDISC standards and other relevant protocoldriven clinical research efforts
  • To link clinical research standards with healthcare standards The BRIDG model is the result of four main stakeholders: the CDISC organisation, the HL7 Regulated Clinical Research Information Management (RCRIM) workgroup, the US National Cancer Institute (NCI) and the FDA.

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Joerg Dillert is Principal Consultant at Phase Forward with over 18 yearsí professional experience both in the pharmaceutical industry and in the application of information technology in industrial scientific research and development. Joerg joined Phase Forward as a Senior Consultant through the merger with Clinsoft Corporation, which he initially joined in 2001. Before joining Clinsoft, Joerg was Head of IT & Data Management at a German CRO for more than nine years. Joerg holds professional qualifications in Electrical & System Engineering as well as in IT-Marketing. In his current role, Joerg supports all the technical aspects of IT system integrations and holds training courses. He has trained more than 500 people in eight years and developed course material on several areas such as XML, Oracle and CDISC.

 

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