CTMG, Inc.

Biotechnology ResearchUnited States11-50 Employees

CTMG, Inc. provides unparalleled speed and data certainty in completing Sponsored clinical trials per originally forecast timelines.  We accomplish this through our unique business structure of partnering with our Network Physician Investigative Sites, and providing the world’s first cGMP-like processes to translate specific protocol requirements into discrete measurable steps.  Completion of these steps as intended is assured by CTMG’s real time quality systems, as the data is collected at our Business Associate physician sites.  This cGMP-like approach to clinical trial site conduct enables real time identification of operational barriers, with rapid solution formation and implementation, thus adapting the processes to meet specific site and protocol needs.   

CTMG’s Adaptive Investigative Site Management® service has a proven record in maximizing Investigative Site Performance across a wide range of therapeutic areas.  Between 2011-13, CTMG conducted eleven studies in which our average Investigative Site enrollment was 5-30 times greater per month than the average of non-CTMG sites (in studies in which non-CTMG sites were also utilized by Sponsor).  Our data was of superior data quality that enabled four different Sponsors’ test articles to ultimately receive FDA Approval or FDA Recommendation for Approval in 2011-12 alone.

Most importantly, the FDA became aware of CTMG’s ability to enroll order of magnitude more patients, yet submit superior quality data.  We presented our methodology to representatives from the FDA Commissioner’s Office, as well as representatives from the drug, device and biologics divisions, on May 16, 2012.  Our CEO subsequently published the advantages of our SSRO (originally termed “SS-CRO”) cGMP-like approach to clinical trial management in the Food and Drug Law Institute’s Food and Drug Policy Forum on October 9, 2013.

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