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International Clinical Trials

Pharma Champion

CDISC and other standards groups have continued to have an influence on the pharmaceutical industry, writes Mark Penniston at Omnicare Clinical Research

CDISC PROGRESS REPORT

Since its founding, the Clinical Data Interchange Standards Consortium (CDISC) has grown to an international standard organisation with user groups established in multiple worldwide locations. It is a major champion in the pharmaceutical industry for its work in developing platformindependent data standards for the electronic acquisition and exchange of clinical trial data and metadata. As with any organisation of multiple members, lively discussion continues between individual members and their volunteers. The agreement generated by these discussions is probably a factor in the reason why the community has been adapting these standards, and the importance in understanding the efficiencies gained from using them.

Eighteen of the top 20 pharmaceutical companies and eight of the top 10 clinical research organisations (CROs) are currently members of CDISC (1). Since 2000, membership has grown over 600 per cent, with membership renewal rates greater than 88 per cent (2). Additionally, many vendors with supportive tool sets have appeared in the market place, stating their support for the elements of these standards. Membership has grown internationally, particularly in both Europe and the Pacific Rim.


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Mark Penniston, MS, is Vice President of Global Biometrics and Clinical Writing. With a focus on delivering expert service excellence and quality results, Mark brings over 20 years of industry experience to this business. A strong proponent of standardisation and CDISC, Mark led Omnicare Clinical Research to join CDISC in 2004 for the purpose of harmonising internal processes around these globally-recognised definitions.
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Mark Penniston
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