On Monday, April 23rd, Dr. Anton Usala, President and CEO of CTMG, Inc, spoke at the “Modernizing the Regulation of Clinical Trials and Approaches to Good Clinical Practice” FDA public hearing. Dr. Usala discussed how CTMG’s designed reviewed processes, implemented under layered quality systems at the point of service delivery, ensure the most expedient path to acquire high quality data for Sponsors. Dr. Usala proposed an accelerated FDA review path for Sponsor that utilizes Physician Investigative Sites with internal, point of service quality systems. In addition, Dr. Usala’s presentation touched on the potential benefits of amending the Form 1572 in order to better allow the subject matter experts to be responsible for the organization and logistics of a study, while also making certain that the PI is aware and involved in all medical decision making.
When made available, the transcript can be viewed at the following link: http://www.fda.gov/Drugs/NewsEvents/ucm284118.htm
CTMG is the world’s first Site Specific CRO (SS-CRO) with, to the best of our knowledge, the highest clinical study enrollment and retention metrics in the world. Our trial management service utilizes our experienced personnel to implement design-reviewed cGMP-like processes, under proprietary layered Quality Systems, at our Business Associate Physician Investigator sites.
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