Clinical Development

Chiltern becomes a member of CDISC

14-Aug-2014
Last updated on 14-Aug-2014 at 09:48 GMT2014-08-14T09:48:28Z - By Zachary Brennan+
Chiltern becomes a member of CDISC
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CRO Chiltern International has purchased a Gold Membership from non-profit standards consortium CDISC (Clinical Data Interchange Standards Consortium).

Comprised of nearly 300 biotech and pharma companies, as well as CROs (contract research organizations), and academic institutions, CDISC helps to develop and support global data standards that enable information exchange and aim to improve medical research. 

Prior to joining, Chiltern has been following CDISC standards with experience in reporting over 100 studies using the SDTM (Study Data Tabulation Model) and ADaM (Analysis Data Model) models. Now as a member of CDISC, Chiltern will collaborate with global leaders and contribute toward the development and release of new standards. 

Michael Wisniewski, Chiltern’s Senior Executive Director of Biometrics, told us the membership gives Chiltern access to information on data standards that their clients have, “and if our clients have access to it, then it’s good we have membership.” 

The membership also offers Chiltern 20% off of training sessions on the data standards the consortium publishes. “It’s one thing to publish [the standards] and another to be able to understand how to use them…figuring them out on your own is probably more time-consuming than the training,” Wisniewski said. 

The annual fee to be a Gold member of CDISC for companies with more than 100 and less than 1,000 employees is $8,000. Being a Gold member also allows opportunities for organizations to become a CDISC Registered Solution Provider, which serve as subject matter resources to organizations who want to implement CDISC standards.  

In 2012, CDISC was designated as a US charitable organization, which means it can receive tax-deductible donations. 

Matthew Juler, Chiltern’s Manager of Statistical Programming, Europe added: “Chiltern has been producing CDISC compliant data for a number of years, and by attaining Gold membership we look forward to becoming actively involved in the evolution of the CDISC standards. Our membership will ensure that we are able to implement the latest standards as they come online and continue to provide a high quality product for our sponsors.” 

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