INVESTOR NEWSLETTER ISSUE N°3
FIRST QU FALL 2009
ARTER 2016
CFAST such as Schizophrenia, Major Depressive Disorder, and Generalized Anxiety Disorder. We are now working on three standards in Oncology (Breast, Prostate and Colorectal), building upon earlier CDISC work in this area. The re-use of prior work, enabled through CDISC SHARE, will accelerate this process and ensure harmonization across standards. All of this work breaks down silos and benefits patients.
In addition to those mentioned above, CDISC is involved in more projects that encourage “silo-busting,” including the Harvard Multi-Regional Clinical Trials (MRCT) Data-sharing Platform, Innovative Medicines Initiative (IMI) projects such as the eTranslational Research Information Knowledge System (eTRIKS), the Institute of Medicine’s Digital Learning Collaborative, the European Institute for Innovation through Health Data, and the Learning Health Community. And, recently, we learned of the PMDA’s support for mapping Japan’s core health-related dataset to CDISC’s CDASH (a global minimum dataset for clinical research).
These efforts span the globe in terms of breaking down silos to further research and enable a learning health system. Other articles in this newsletter focus on ensuring that we are breaking down silos to encourage sharing and collaboration across and within the CDISC organization, beginning with staff and leadership and moving into CDISC teams and technical projects. This will result in harmonized standards that can transform the way we do research from beginning to end, and bring value to all stakeholders to leverage research data in the development of innovative medicines for patients worldwide.
COO Perspective Dr. Nicole Harmon, CDISC COO
When we were developing the theme for our Q1 2016 Newsletter, we knew we wanted to focus on a topic that was important to clinical research and to our standards development: Reducing Silos. I have now officially been with CDISC for one year and in this time I am often reflecting on my role as Operational Leader of CDISC. I think about what I can do to reduce silos within our staff, to focus on what motivates each staff member, the Directors on the CDISC Board, and each member of the CDISC Advisory Council in order to influence success within the leadership team and for our organization as a whole. “An operational leader is someone who sees how the individual elements of an organization fit together and work to create the larger outcome. When they think about issues, their focus is on what systems and processes are needed or will be impacted. These leaders serve a key role in ensuring that things get done in an effective and efficient manner.” John Maxwell, Maximum Impact (2004).
In my role as the Chief Operating Officer of CDISC, my goals are simple but important, and not necessarily easy. I want to bring long-term stability and sustainable value to CDISC. I want to create a secure infrastructure where people can show their talents and passion but remain focused on core, innovative, strategic goals. I love to think strategically and plan for the long-term, but it is essential to also have the right pieces in place to carry out our plans and make sure we have policies for the details. CDISC is working to improve internal communication within our staff and external communication to our members, implementers and stakeholders. Our Technical Leaders are working to focus on improving the process for how each of the standards teams can work together; concurrently, I am working to improve a process for how all CDISC Leaders and Staff (including Member Relations, PR/Communications, Events, Finance and IT) work effectively in a cross-functional manner. As such, our CDISC Strategic Goals are translated each year into Operational Goals and then into specific and measurable Cross-Functional Goals. All CDISC staff are evaluated each year on their performance in accordance with these goals. The first two layers are shown below and all goals align with the 2016 CDISC Roadmap.
We are excited to welcome two new CDISC Technical Leaders, Barrie Nelson, VP of Standards, Technology and Technical Services and Lauren Becnel, PhD, Director, Bioinformatics and Alliances. I hope that the CDISC staff
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