Founded in April of 2004 by Anton-Lewis Usala, MD, CTMG is the only clinical trial management organization that provides Adaptive Investigative Site Management® services as a Site Specific Research Organization (“SSRO”). 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 cGxP-like processes, administered under Quality System review as the data is obtained, 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 discrete, measurable steps at the Investigative Site. The completion of these processes is continuously monitored and reviewed as the study data is collected to ensure the protocol is completed as intended, on time, 100% of the time.
CTMG personnel work side-by-side with our Business Associate (as defined by the HIPAA Omnibus Final Rule of 2013) Physician Investigators to assist them 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 ensure Investigator compliance with our design-reviewed processes at the time the data is collected. This continuous review of process completion, with rapid barrier identification and elimination, consistently reduces direct clinical trial costs by several million dollars, improves patient safety, produces superior quality data, cuts 1-3 years off of clinical trial timelines, and thereby increases incremental sales revenue through earlier FDA approval and market sales.