“CDISC Europe, IMI and the Spark of Opportunity”

Bron Kisler, VP CDISC Strategic Initiatives recently had the opportunity to give the keynote presentation at the IMI EHR4CR Annual Stakeholder meeting in Berlin, Germany, November 2013. In addition to the CDISC collaboration in this IMI consortium, the presentation also reflected on the history of CDISC in Europe and recent CDISC progress. A team of dedicated volunteers - the CDISC European Coordinating Committee (E3C) - has ensured CDISC's pres-ence in Europe for over 10-years, organizing annual events, user networks and public awareness of CDISC. The 2014 CDISC Europe Interchange meeting will be held in Paris, April 2014.

“As I look back on more recent successes, the IMI EHR4CR project (http://www.ehr4cr.eu) seems to be an impor-tant tipping point for CDISC in Europe, leading to rapidly expanding opportunities.”

“EHR4CR is the first IMI project in which CDISC was invited to be a partner organization. This quickly led to addi-tional key milestones in Europe: (1) CDISC and IMI signed a Memorandum of Understanding in 2011; (2) CDISC was invited to be a partner on the IMI BioVacSafe project; and (3) the CDISC Europe Foundation was formed in Brussels. Additionally, CDISC is now a partner in the IMI consortium for eTRIKS - European Translational Information & Knowledge Management Services, and CDISC standards are being implemented across other IMI projects such as PredDiCT TB.”

“The EHR4CR and other IMI consortia have paved the way for a much closer working relationship among CDISC, EFPIA companies, academic institutions and other key stakeholders across Europe. The IMI business model is incredibly effective at incentivizing collaboration. CDISC believes in strength through collaboration. We really enjoy working with our friends and colleagues in Europe, fuelled by this spirit of collaboration.”

But, the story does not end there. In June 2013, the European Medicines Agency (EMA) released draft policy for Publication and Access to Clinical Trial Data as part of the EMA's Clinical Trial Transparency Initiative. The draft policy states - "In future, CDISC shall be the required standard, in line with future guidance from the Agency". EMA is currently addressing public comments received this year and plans to release final policy in the near future. Simi-lar position statements were released in September by the US Food & Drug Administration (FDA) and Pharmaceuti-cal Medical Devices Agency in Japan (PMDA), thus spanning the regions of the world encompassed by ICH - Inter-national Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use. Similar considerations, regarding CDISC standards, are being made by regulators in China and Korea as well.

EHR4CR is a spark that has led to incredible opportunity in Europe and around the globe to streamline clinical research through the use of EHRs and Standards. We in CDISC look forward to the coming year in Europe, as this spark continues to ignite further opportunities.

December 10th 2013Bron Kisler, VP Strategic Initiatives, CDISC & Rebecca Kush, CEO, CDISC

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