Nicholas Pemble

Nicholas Pemble

Head of Data Collection Standards

The Janssen Pharmaceutical Companies of Johnson & Johnson

How long have you been volunteering at CDISC?

So long ago that that it is hard to be precise. In ISO8601 terms I would say about P14Y.

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

Having worked for a CRO in the 1990’s, I experienced a wide variety of Sponsor specific standards. When first exposed to CDISC in 2005, I perceived it to be the most important development in clinical data management since the birth of modern computing. I wanted to be part of that movement, to learn, to influence and to contribute. Most recently I have become fascinated about how CDISC standards fit within the entire healthcare standards ecosystem and the opportunities that standards interoperability can bring in terms of improving healthcare outcomes.

How did you begin working in clinical research?

There was no plan. In fact, clinical biology was the least favorite part of my graduate degree, however in unemployment-riddled Britain in the early nineties, graduate opportunities were scarce. After about 120 job applications and five interviews, I was grateful to be afforded the opportunity to work for a small CRO in the south of England as a Clinical Data Manager. I really liked it, and the rest is history.

What did you want to be when you grew up?

Lots of things. Firstly, I wanted to be a football (soccer) player but got tonsilitis on the day of the county trials. Next a musician but I did not have the talent, so I switched my attention to science and wanted to be a marine biologist, however, since I can neither swim well nor dive, I satisfied myself with being a generalist and biological scientist.

You have encouraged many of your staff to volunteer on various teams at CDISC. Can you share with us the value that your organization has gained from such active volunteer engagement?

I have deep respect for the standards and scientific expertise of my team and that of my fellow volunteers within the CDISC community. Encouraging volunteering is a “no brainer.” Myself and my team get opportunities to develop and interact with other like-minded individuals across industry and academia. We also get an opportunity to try to influence the direction of the standards and we get advanced insights into the future development of standards so that we can make sure our organization is as well prepared as possible. CDISC gets our time, experience and expertise, and an additional user/sponsor view on implementation of the Standards. It is a true win-win.

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

Firstly, at a high level, be a standards pragmatist. Science evolves and standards evolve, often on different timelines. Align with the key requirements and terminology but apply the standards in a way that makes sense and brings value to your, or your organization’s needs.

Secondly, with my terminology hat on, read the definitions and apply terminology accurately. Terminology is the “beating heart” of standards and key to interoperability. If you can’t find it, request it.

Lastly, if you have the opportunity, don’t be shy and volunteer. Both you and the CDISC organization will be better for it. We are the sum of our experiences.