Founded in April of 2004 by Anton-Lewis Usala, MD, CTMG is the only organization that provides Adaptive Investigative Site Management services as a Site Specific CRO. These services enable clinical trial protocol completion as intended at each Investigative Site, with superior data acquisition per forecast timelines, 100% of the time.
Dr. Usala had founded several biotech companies, guiding new products from discovery through FDA approval. He noted that the only aspect of drug development that does not currently require design-reviewed cGMP-like processes administered under Quality Systems, is the clinical trial portion involving human patients. CTMG’s Adaptive Investigative Site Management creates design-reviewed, protocol-specific processes that translate protocol requirements into discreet, measurable steps at the Investigative Site. The completion of these processes are continuously monitored and reviewed as the data is collected to assure the protocol is completed as intended, on time, 100% of the time.
CTMG personnel work side-by-side our Business Associate (as defined by the HIPAA Omnibus Final Rule of 2013) Physician Investigators to assist the PI in conducting the clinical trial in compliance with CTMG’s quality system-based processes. Thus, unlike traditional CROs, CTMG personnel are able to assist and immediately assure Investigator compliance with our design-reviewed processes at the time the data is collected. This continuous review of process completion, with immediate barrier identification and elimination, consistently cuts 1-3 years off of clinical trial timelines.