Anton Usala, MD, CTMG’s President and CEO, and members of the CTMG executive team were invited to meet with representatives of all three branches of the FDA (CDER, CBER, and CDRH), representatives from the FDA Commissioner’s Office on GCPs, FDA Enforcement, FDA veterinary medicine, and FDA Office of Scientific Research/Integrity to present CTMG’s successful approach to clinical trial conduct, on May 16, 2012 at FDA Headquarters in Silver Spring, MD.
CTMG is the world’s first Site Specific CRO, that develops and implements protocol-specific, design-reviewed processes, to conduct clinical trials with its Business Associate Physician Investigators. Dr. Usala explained that by implementing these processes under point-of-process completion layered quality systems at the Investigative Site, CTMG sites have 1) been the first to recognize test article related adverse events, 2) been the top enrolling sites with the highest retention rates in nearly all studies conducted between 2008-12, that enables recognition of both safety and efficacy trends by the Investigators, 3) reduces the time to bring a product through clinical trials by up to 3 years, and 4) cuts the cost of conducting the clinical trial by tens of millions of dollars.
CTMG also presented for FDA consideration two options to accelerate FDA review of Sponsor clinical trial data—1) if Sponsors conduct studies at clinical investigative sites that have onsite quality systems (such as those done at CTMG network sites), the FDA will place those study data in the established FDA accelerated review track, and 2) provide the option for Principal Investigators to check responsibility for medical procedures, medical review of data, medical decision making, and medical data interpretation, but delegate to other subject matter experts (such as CTMG) the operational and on site quality system conduct of the study at their site [the rationale being that physicians are NOT subject matter experts in clinical trial operations or quality systems, and only subject matter experts in the medical aspects of the clinical trials].
CTMG is the world’s first Site Specific CRO (SS-CRO) with, to the best of our knowledge, the highest clinical study enrollment and retention metrics in the world. Our trial management service utilizes our experienced personnel to implement design-reviewed cGMP-like processes, under proprietary layered Quality Systems, at our Business Associate Physician Investigator sites.
