About Me

I am a consultant who helps small biotechnology and medical device companies and Clinical Research Organizations manage their Clinical Data Management and Clinical Research Technology needs.
I have hands-on experience working with both small and large companies in the technology arena.
I ORGANIZE clinical research data to help companies bring their products to market.
I MANAGE technology and people to make the clinical research process more efficient..
I CREATE systems that enable teams to increase research efficiency.


I’m a pharmaceutical clinical research consultant with 29 years experience in the US, Canada, and Europe, including 26 years in phase I-IV clinical trials and registries. I’ve worked in the pharmaceutical, biotech, and medical device industries and in academia. For the past eight years, I’ve worked primarily as a telecommuter from my home in New Orleans.

I’m also a SAS programmer, and I’ve managed software system selection, configuration, validation, and implementation projects. My primary expertise is Clinical Data Management in small to mid-sized Sponsor companies and Clinical Research Organizations. I have extensive experience with Electronic Data Capture (EDC) for clinical trials and registries using various software systems.

I’m an experienced manager of remote employees and teams, as well as skilled in project management and vendor management of outsourced projects.

My academic training includes a Master of Science in Community Health/Epidemiology from The University of Texas School of Public Health and a Bachelor of Arts in Psychology and Political Science from Tulane University.

Another way to say all of the above: I help companies get their new drugs and devices approved by the FDA and other regulatory agencies by helping them collect, clean, and report their data properly and efficiently.

I’m available for consulting work – both on-site and remote. Please email me at kenneth@kmilstead.com for more information. You can also view my LinkedIn profile at¬†https://www.linkedin.com/in/krmilstead/.