Dir. of Clinical & Regulatory Affairs
Pamela Lapham is responsible for conducting and monitoring ProMedDx clinical trials intended for specimen collection, biobanking, and biostorage. She also oversees the ProMedDx Quality Management System.
Prior to joining the ProMedDx team, Pamela was the Clinical and Regulatory Project Manager at Ximedica, an ISO 13485-certified medical products development company, where she led clinical research teams in successfully applying FDA regulatory and GCP guidelines for designing, conducting, analyzing, and reporting clinical feasibility/ pivotal studies and formative/validation studies in order to gain regulatory clearances/approvals of combination products and medical devices. Before that, she spent 20 years leading translational medicine R&D, manufacturing, and clinical teams in the discovery, development, and GMP manufacture of investigational new drugs and biologicals for early Phase I/II clinical trials at Roger Williams Medical Center.
Pamela holds a Bachelor of Science in biology from the University of Massachusetts Dartmouth, and advanced certification in Regulatory Affairs from San Diego State University where she also studied biomedical quality systems.