Dr. Usala founded CTMG, Inc. in 2004 to address the gaps he observed in site clinical trial quality systems first as a University Medical Center researcher, and later as he directed the Biotechnology company he founded (Encelle, Inc.) into FDA monitored clinical trials. While at his biotechnology company, Dr. Usala observed all facets of investigational product development are controlled by cGXP-linked quality systems, except for the human clinical research portion conducted at Physician Investigator sites. Dr. Usala devised Quality Systems, using the principles of cGMP review and Corrective and Preventative Action (CAPA) Systems, for use at clinical investigative sites with the goal of effectively and reproducibly assuring site performance. Since April 2004, Dr. Usala has led the only clinical trial management group to effectively implement, design and utilize design-reviewed GMP-like processes, under layered Quality Systems at the point of clinical trial service delivery, to ensure that what is intended in the investigative protocol is actually done at the investigative site. His designed systems approach has resulted in CTMG’s rapid patient enrollment and retention, resulting in most sites reaching or exceeding contracted patient numbers (compared to only 25% site success nationally). Dr. Usala is author of 18 U.S. patents, and has testified seven times before different U.S. Senate and House subcommittees on issues related to regenerative medicine research. Dr. Usala received his undergraduate degree in Biology and Political Science from Swarthmore College, his Medical Degree fromJefferson Medical College, and his pediatric and pediatric endocrinology/pharmacology training at Case Western ReserveUniversity.