About GxP Excellence Consulting

Founder's Story: From Patient to Executive

My journey began at a young age when I was diagnosed with severe asthma and participated in several clinical trials throughout my childhood. This early exposure to the impact of clinical research inspired my passion for advancing medicine and ensuring access to new treatments. ​Driven by this passion, I pursued a nursing career and graduated from the University of South Florida as an RN, specializing as a Pediatric Hematology/Oncology nurse. In this role, I administered therapies to children on clinical trials and witnessed firsthand the importance of accelerating the approval of new treatments. This experience led me to transition into a clinical research nurse role, where I collaborated closely with the IRB, Sponsors, CROs. and vendors to coordinate clinical trials at the site level in the Pediatric Hematology/Oncology department.

​

In 2003, I transitioned into a Clinical Research Associate (CRA) role at a large pharmaceutical company, where I spent 18 years advancing through various roles of increasing responsibility. Throughout my career, I have worked on Oncology, Medical, Vaccine, and Immunotherapy studies, overseeing medical and operational feasibility, patient recruitment, and key submission trials. I have led global teams to ensure compliance with GCP, health authority regulations, and internal SOPs, developed risk-based monitoring strategies, and played an integral role in inspection readiness and follow-up actions during regulatory inspections. Additionally, I have developed and led training programs for global monitoring and site oversight teams.

​

I later moved to another large pharmaceutical company, where I provided leadership and strategic guidance for high-priority, cross-functional projects focused on the transformation of global development operations. I played a pivotal role in shaping the future operational strategies and processes for global development operations.

​

Most recently, I created and led the operational strategy for a new site network, driving excellence in trial delivery, regulatory compliance, and patient safety. This included overseeing budget planning, resource allocation, risk management, and ensuring inspection readiness across the network. I also managed process and gap analyses, CAPA development, and internal and external partner collaboration to ensure optimal clinical trial performance.

I started GxP Excellence Consulting in order to share my extensive industry knowledge and drive improvements in the speed and quality of clinical trials. With a broad and diverse background, I provide practical, customized solutions to pharmaceutical companies and research sites, helping them navigate complex regulatory landscapes and enhance GxP compliance.

​​

I look forward to partnering with you to drive success through strategic GxP compliance and operational excellence!

​

Sally Wynn

​