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We all talk and hear these days ...

Posted Nov 10 2008 4:17pm

We all talk and hear these days on the needs for “standards” with data interchange and the FDA is working along side it appears with utilizing the non profit agency to train reviewers.  Hopefully this will contribute to everyone being on the same path and open the door for some additional modern use of technology. 

If you take a look at the membership, you will see one large mixture of companies from everyone like Microsoft, Adobe, Cisco, Abbot Labs, Pfizer, Lilly, Amgen and many more, so the message is pretty clear here as this is not just a technology site, but many of the major pharmaceutical companies, Biotech companies, Genomics included, are participating to bring some standards and unity together so the data and vital information can flow freely to where it is needed without having to re-write the code every time a function is required that more than likely will be used in another location as well

The only way this will happen is by standardization and good to know that the FDA is in the loop and future reviewers will be trained with such standards as they are developed.  How active is the global effort, there are road shows and one large event scheduled next month in China.   The FDA as I have reported is busy setting up their own new advanced network so perhaps with working with the consortium it can be created right from the start with some global standards and hopefully get all working with technology and dump the old paper methodologies in part of the process.  BD

The Clinical Data Interchange Standards Consortium (CDISC), announced today that the Food and Drug Administration (FDA) selected CDISC, via a formal RFP process, to provide training to FDA reviewers of regulatory submissions. The courses to be taught over the next two years will include CDISC Basics, the CDISC Study Data Tabulation Model (SDTM), the CDISC Analysis Data Model (ADaM) and Advanced Topics on CDISC Standards.

image “CDISC is a global, open, multidisciplinary, non-profit organization that has established standards to support the acquisition, exchange, submission and archive of clinical research data and metadata. The CDISC mission is to develop and support global, platform-independent data standards that enable information system interoperability to improve medical research and related areas of healthcare.   CDISC standards are vendor-neutral, platform-independent and freely available via the CDISC website.”

CDISC Awarded Contract For Training Of FDA Reviewers

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