Rowena Rubio

Background

About Rowena Rubio

I’m a pharmaceutical industry quality assurance and compliance expert with extensive experience in GMP, GCP, and Part 11 Compliance and a thorough understanding of the pain points of clinical trials. As an entrepreneurial problem solver, I co-founded a company to streamline the data verification and review process. Our patent-pending software revolutionizes the way pharmaceutical companies collect, review, and verify clinical trial data by directly pulling it from EHRs/EMRs—eliminating the need for costly, time-intensive intermediaries like EDC systems, e-sources, and handwritten records. WHO WE WORK WITH: Pharmaceutical company CROs, procurement departments, and physicians. WHY IT WORKS: Working within pharmaceutical start-up environments gave me unique insight on issues affecting pharmaceutical companies as well as the opportunity to take on projects that would not have been possible at a larger company. Although I've been laying the groundwork on this software project since 2015, it is even more timely in today's climate of limited travel and fully remote teams that has derailed product development timelines. WHAT MAKES ME DIFFERENT: While my primary career experience has been in pharmaceutical QA, I’m also an artist whose advanced training has taught me to formulate strategy, conduct research, and uncover insights by analyzing the human perspective. This blended background has also helped me generate creative approaches to complex business problems while adhering to strict project management and quality standards. BEYOND THE OFFICE: I enjoy skiing, cycling, swimming, photography, knitting, crocheting, gaming (World of Warcraft), and learning sign language. WANT TO TALK? Connect with me here on LinkedIn or email me at rowena@ikeguchiholdings.com.