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”).
Just as Adaptive Clinical Trial design enables cost-effective and operationally efficient paths to be selected during a study based on pre-established data patterns, so does Adaptive Investigative-Site Management® enable efficient adaptation of operational processes at the Investigative Site based on real time feedback on patient progress through study events. These services enable clinical trial protocol completion as intended at each Investigative Site, with superior data acquisition per forecast timelines.
Dr. Usala founded several biotech companies in the past, guiding new products from discovery through FDA approval. He noted then that the only aspect of drug development not requiring design-reviewed cGxP-like processes, administered under Quality System review as the data is obtained, was the clinical trial portion involving human patients.
CTMG’s Adaptive Investigative-Site Management® (“AIM”) 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 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 Physician Investigators as Business Associates (as defined by the HIPAA Omnibus Final Rule of 2013). Unlike Sponsor CROs, CTMG’s SSRO personnel are able to assist and immediately ensure Investigator compliance with our design-reviewed processes at the time the data is collected. Similar to Adaptive Clinical Trial design’s reliance on interim data to guide efficient forward path selection, AIM’s 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, and cuts 1-3 years off of clinical trial timelines– thereby increasing incremental sales revenue for Sponsor through earlier FDA approval and market sales.