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 in the past, guiding new products from discovery through FDA approval. He noted that the only aspect of drug development not requiring 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® (“AISM”) 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.
CTMG’s Adaptive Investigative Site Management® (“AISM”) can be a valuable resource to a clinical trial.
- Continuous review of process completion
- Rapid Barrier identification and elimination
- Consistent reduction of direct clinical trial cost by several million dollars
- Improves patient safety
- Produces superior quality data
- Cuts 1-3 years off of clinical trial completion timelines
- Acceleration of product commercialization success
CTMG personnel work side-by-side with our Business Associate Physician Investigators (as defined by the HIPAA Omnibus Final Rule of 2013) 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 protocol specific processes at the time the data is collected.