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CTMG, Inc. is the first Site Specific, clinical trial contract research organization utilizing design-reviewed, cGMP-like process controls, administered under layered quality systems at the point of clinical trial service at Physician Investigator sites.

The systems and approach used by CTMG (design-reviewed, cGMP-like processes, administered under layered quality systems at point of service) have proven themselves effective in all other stages of drug development.  Remarkably, such Quality-based Systems are to date not yet required by the FDA in clinical trials.

A combination of unique management skills and quality control systems creates a reliable, consistent pathway to success for private practice physicians.  CTMG's proprietary systems routinely enable a private practice physician site to become the number one enroller in their chosen study regardless of personal clinical trial experience.

Operationally effective, expertly managed and provided at the point of clinical trial service delivery, CTMG systems ensure the best results through:

• Predictably rapid subject enrollment and dependable retention.
• Oversight by highly skilled and experienced CTMG management personnel.
• Daily review meetings and specifically designed oversight and evaluation processes, including in depth Standard Operating Procedures (SOP)
• An integrated Corrective and Preventative Action System (CAPA) that ensures what is operationally intended is in fact done during the course of the study.
• State of the art technology providing remote study data access under 21 CFR Part 11 compliance.

As a result.....

Site failure rates are dramatically reduced so that fewer investigative sites are required by Sponsor, and a complete audit trail is created that can be reviewed both by Sponsor and the FDA to determine how the data was obtained.

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Nationally, over 70% of clinical sites are either under or non-performing. While all other aspects of drug development require the use of design reviewed process controls under layered Quality Systems, the final phase, when physician investigators implement FDA-approved clinical protocols, is exempt from this key quality requirement.

             The 

                    Solution...

Fact:  CTMG is the only clinical trial management group that applies cGMP-like processes administered under layeredQuality Systems at the investigator point of service, to manage clinical trials at our sub-contracted Business Associate Physician Investigator offices. 
               

Fact:  These Quality Systems ensure compliance with the FDA’s recent guidance on investigator responsibilities in clinical trial management and have made CTMG the nation’s top enroller in the last five studies completed.

Fact:  CTMG’s metrics demonstrate unequivocally superior results, and clearly show the effectiveness of our “Six Sigma” Quality Systems approach, with the percentage of CTMG sites meeting or exceeding contracted enrollment numbers.