Our "Meet the Expert" series introduces you to our team of experts around the world. This "behind the curtain" view will help you get to know who we are on a professional and personal level, and highlight how our colleagues work together on our higher purpose to improve patient health and safety throughout the complete product lifecycle.
As a Lead Clinical Systems Consultant, I guide clients through their entire lifecycle of R&D system adoption. Project management, configuration, and post-implementation services are just a few of the activities I support. A day in my life often entails meeting with clients to understand business needs, developing tools to maximize their end user adoption, and contributing to ProPharma's internal R&D Technology knowledge base.
Life science organizations have complex quality, clinical, and regulatory requirements, and it's critical that their technology is fit-for-use. My objective is to enable customer success by not only earning operational efficiencies with each successful implementation, but also ensuring the solutions comply with current regulations and GxP principles. In turn, our clients can accelerate developments of new treatments, which better positions them to improve patient outcomes.
I've been fortunate to work with clients ranging from emerging biotech startups to top 20 pharmaceutical companies. I love building relationships with each customer and developing an understanding of their goals, challenges, and needs. Every organization is different, which allows me to design innovative solutions and glean insights on industry trends. Through consulting, I see the tangible impact of my efforts.
Change is the only constant. Regulations are often revisited due to scientific advancements, societal concerns, and legislative shifts, among myriad other reasons. The exigency of Emergency Use Authorizations (EUAs) during COVID-19 and the replacement of Directive 2001/20/EC with EU Clinical Trial Regulation 536/2014 (EU-CTR) are two recent examples.
This lesson has taught me the importance of adaptability and agility. As organizations seek to embrace new submission and approval processes, their R&D solutions must align quickly with evolving needs. Cloud computing can empower organizations to dismantle informational siloes and keep pace with regulatory changes—but only if they implement such technology wisely. Likewise, continuous learning about new software and market trends is critical in my line of work.
I'm an aficionada of travel and nature. Cultures and languages fascinate me because they introduce me to fresh perspectives and ways of living. I've been to fourteen countries so far and have many more to go! Post-pandemic, I've developed a strong appreciation of the outdoors and recently got into half-marathons. I completed my first half in Zion National Park and am looking forward to my next race in Mount Rainier. When I'm not running (on a trail or off to another continent), you'll find me curled up with a good book.
ProPharma's domain expertise spans not only multiple therapeutic areas, but also a variety of services in R&D technology, regulatory science, clinical research, quality, pharmacovigilance, and medical information. We have the capability to be a single-source provider for your organization no matter your product's development phase. I'm proud to work at a Research Consulting Organization (RCO) that is mission-driven to improve patient health and safety.
January 13, 2021
As you plan for an upcoming Tech Transfer, have you considered if you are appropriately prepared to conduct an analytical method transfer? With the simple analytical method transfer checklist...
May 7, 2014
As the pharmaceutical supply chain evolves, at some point product/technology transfers will become part of the improvement process. When transferring production from site to site, an array of complex...
January 24, 2014
Today we’re back with the next step in the Nine Gate Transfer Process for Moving Production from site to sitea>. So far we’ve covered the first four gates, which you can review in our last blog post....