Nikki Flores

Nikki Flores

Associate Director, CDM CORE (Standards, Technology & Solutions)

Gilead Sciences, Inc.

How long have you been volunteering at CDISC?

I started volunteering at CDISC in 2013 and worked on the Chronic Hepatitis C Therapeutic Area User Guide, which was published in 2015. After that, I worked on the Rheumatoid Arthritis TAUG and started working on the CDASH standards.

What encouraged you to volunteer your time and expertise with CDISC?

My manager has always been a great advocate for establishing standards at Gilead. In 2015, she presented me with an opportunity to lead Gilead’s newly established group called CDM CORE, which focuses on centralized data collection standards and providing oversight across all studies in multiple therapeutic areas.

Volunteering my time with CDISC provides me an opportunity to learn about CDISC standards and processes, which my team at Gilead implement and help provide guidance for our stakeholders. It’s also a bonus that I get an opportunity to collaborate with a lot of brilliant volunteers from other companies!

How did you begin working in clinical research?

After college, I started working in the lab at University of California, San Francisco that focused on pediatric oncology research. I worked under a brilliant and passionate cancer specialist who is also highly involved in the Children’s Oncology Group (COG), which provided opportunities for multiple clinical trial collaborations that were sponsored by COG. While my main responsibilities involved lab work/experiments as well as managing the Hematopoietic tissue cell bank, working in her lab opened my eyes beyond academic research, which led me to pursue a career in clinical research, particularly clinical data management.

What did you want to be when you grew up?

A lot of people in my family are in medical-based careers and most are in the nursing field. So, when I was growing up in the Philippines, I was exposed to that environment and grew up wanting to be a doctor or a nurse. My immediate family and I ended up immigrating to the US in the late 90’s, which allowed me to go to college and be exposed to other possible career choices outside of medicine.

CDASH is not required for submissions to the FDA or PMDA, why should people use it anyway?

CDASH establishes a standard way to collect data that are user friendly that would help maximize data quality and be applied consistently across studies. Using CDASH facilitates study startup, data validation and other downstream programming activities such as creation of SDTM and ADaM datasets, which will reduce time for submission to regulatory authorities.

CDASH provides clear traceability of submission data as most variables map directly to SDTM, which will then provide transparency to regulators and others who conduct data review. CDASH helps advance therapeutics as it provides a foundation for drug development and clinical excellence.

Please provide a tip that someone would find helpful in working with CDISC Standards.

The Knowledge Base is a great resource! It has a lot of information such as articles, eCRF Portal and Examples Collection for each data state. The Knowledge Base is always evolving so if there’s anything that people feel should be added, reach out to the Foundational Standards team leads and/or project managers so we can work on publishing more articles.