Darren LaCour Jr. is a distinguished biomedical product development professional with a deep expertise in navigating the complex regulatory landscape of the U.S. healthcare system. With a robust foundation in Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP), and Good Clinical Practices (GCP), Darren has played a pivotal role in advancing medical products from the bench to bedside, ensuring their compliance with stringent regulatory standards.
Darren’s career began as a Pharmaceutical Chemist, where he honed his skills in the intricate processes of drug development. His passion for innovation and patient safety led him to transition into the clinical research industry, where he has since focused on the design and execution of clinical trials, particularly in the endovascular space. His leadership in overseeing clinical data input and managing the various phases of product development has been instrumental in the successful approval of numerous medical devices.
As the Founder of Ology Universal Research Solutions, Darren has leveraged his extensive industry knowledge to provide strategic guidance and clinical research services, helping organizations navigate the challenging path to regulatory approval. His leadership extends to his role as Director of Global Clinical Affairs at Stryker, where he is responsible for the global strategy and execution of clinical trials that ensure the safety and efficacy of innovative medical technologies.
Darren is also committed to education and mentorship. Since 2017, he has served as an Instructor at the University of California, Irvine Division of Continuing Education, where he shares his expertise in clinical trials and regulatory affairs with the next generation of industry leaders. His academic background includes an M.S. in Regulatory Affairs for Pharmaceuticals, Medical Devices, and Biologics from Northeastern University, and a Bachelor of Science in Biology from Xavier University of Louisiana.
Throughout his career, Darren has been a strong advocate for diversity in clinical research, focusing on talent development, performance management, and quality management of clinical vendors. His strategic approach to clinical trial planning, execution, and monitoring has made him a respected leader in the field. Darren’s commitment to protecting the rights, welfare, and safety of research subjects remains at the forefront of his professional endeavors, as he continues to influence the biomedical landscape with his expertise and dedication.
Character: Darren LaCour Jr. is a committed leader dedicated to advancing patient safety and regulatory compliance in biomedical product development.
Knowledge: He possesses deep expertise in GMP, GLP, GCP, and clinical trial execution, particularly in endovascular product development.
Strategic: Darren’s strategic leadership has guided numerous medical products from development to regulatory approval.
Communication: He is an effective educator and mentor, sharing his clinical research knowledge through his role at the University of California, Irvine.
