Enrollment Goals and Timelines Achieved with CTMG Adaptive Site Management

A Sponsor conducting an international Phase II study was experiencing significant enrollment challenges as a result of a complex protocol, with only six of a required 60 patients enrolled after 14 months. CTMG was approached as a “rescue” enrollment solution, and contracted to enroll a total of 30 subjects. Prior to achieving this enrollment goal, […]

CTMG presents its Site Specific CRO Model, and two options for accelerated review of study data, to FDA GCP Roundtable

Anton Usala, MD, CTMG’s President and CEO, and members of the CTMG executive team were invited to meet with representatives of all three branches of the FDA (CDER, CBER, and CDRH), representatives from the FDA Commissioner’s Office on GCPs, FDA Enforcement, viagra sans ordonnance FDA veterinary medicine, and FDA Office of Scientific Research/Integrity to present […]

CTMG, Inc. President and CEO at FDA Public Hearing

On Monday, April 23rd, Dr. Anton Usala, President and CEO of CTMG, Inc, spoke at the “Modernizing the Regulation of Clinical Trials coupons for levitra and Approaches to Good Clinical Practice” FDA public hearing. Dr. Usala discussed how CTMG’s designed reviewed processes, implemented levitra online under layered quality systems at the point of service delivery, […]

CTMG Process Controls Effectively Address New FDA Guidance for Oversight of Clinical Trials

The FDA has recently released a new guidance regarding how Sponsor/ Sponsor side CROs should be monitoring their clinical trial sites. The guidance primarily notes that the main https://www.viagrasansordonnancefr.com/viagra-naturel/ focus for Sponsors and Sponsor side CROs should be on taking measures which protect human subjects, while maintaining data integrity and compliance with regulations. Many Sponsors […]

The Problem is Not with the FDA

Recently, a colleague sent me a link to an article about the Venture Capital lobby pressuring the tadalafil tunisie FDA to speed up their review process. http://www.xconomy.com/national/2011/04/25/vcs-turn-up-the-heat-on-fda-to-get-faster-more-predictable-to-save-u-s-jobs/ This is one of many such pieces to appear online. As the above article points out, Venture Capital has pulled back from investing in start-up biotechnology/pharmaceutical/medical device companies […]