ABOUT

Denise DeRenzo Lacey, RQAP-GCP, has over twenty years’ experience in clinical Quality Assurance and clinical development operations.  Her practice focuses on application of quality risk management techniques for clinical studies, including risk-based approaches to auditing, data quality, data integrity, and even SOP development.  She has provided consulting services to a wide range of pharmaceutical, medical device, biotech and CRO clients in the US and Europe and has held senior positions at Vertex Pharmaceuticals and Radius Health.

 

Prior to her work in clinical development, Denise was a teacher of English language and literature at the secondary and university levels, including three years in Tunisia as a member of the United States Peace Corps. 

 

Denise holds a Master of Science from the University of Pennsylvania, a Master of Arts from Villanova University, and a Bachelor of Arts from Dickinson College. She is a frequent presenter at industry meetings and is a certified Registered Quality Assurance Professional in Good Clinical Practice (RQAP-GCP) by the Society of Quality Assurance.

A syncline is a geological structure of folded, stratified rock. “Synclinical” is a play upon that term that emphasizes the collaborative, synergistic nature of clinical development.