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September 19th, 2007 @ 1-3pm EDT
CIMPS—A GMP Approach to Physician Site Management Enabling Clinical Trial Success (Regardless of PI Experience)

CTMG, Inc. SPEAKER PANEL
- Anton Usala, M.D., CEO & Medical Director  Learn More
- Christopher Hasty, M.D., Principal Investigator Researcher  Learn More
- Jeffrey Hoggard, M.D., Principal Investigator Researcher  Learn More
Mark Cervi, M.D., Principal Investigator Researcher  Learn More


While the breakdown in Investigator site clinical study productivity is well known, there has been little change in the methods utilized by either Sponsors or Clinical Investigators to improve clinical study metrics. The Clinical Investigator Management Process System (CIMPS) catapults system control, quality assurance, and qualified personnel into private physician offices, resulting in reduced risk of underperformance at most sites.

The CIMPS utilizes existing Clinician assets to integrate within a system control overlay that:

  1. Does not interrupt the core business flow of the Private Physician investigator
  2. Ensures under quality systems that the specific Sponsor protocol and Regulatory requirements are met
  3. Builds a partnership atmosphere between Sponsors and the Investigators. Utilizing the CIMPS, previous Investigator experience is not required to be successful, as the personnel and systems are provided by the management service company.
THIS PROGRAM IS INTENDED FOR:

Pharmaceutical and Medical Device Sponsor Personnel (and their CRO Partners) involved with Clinical Trial Site Selection, Budgeting, and Regulatory Submissions. 

SPONSORING PARTNER:


 

CTMG, Inc., located in Wilson and Greenville, North Carolina, is now in its fourth year offering a unique system of process/operational controls that are brought to private Physician Investigator (PI) offices by experienced Contract, Finance, Regulatory, and Clinical personnel. This Clinical Investigator Management Process System (CIMPS) delivers complete study management for Phase 1, 2, and 3 Sponsor Studies in the U.S.  Recent expansion into India has allowed CTMG to take advantage of identified clinical sites conducting studies under ICH/FDA regulations, with significantly decreased patient recruitment times, and reduced costs. With full access throughout Europe, CTMG has positioned itself to have a true global scope. The CTMG CIMPS brings cGMP-like control for the first time into physician offices conducting clinical trials, reducing underperformance risk to the Sponsor, and making clinical studies economically feasible for busy clinical physicians so their core business of seeing patients is not interrupted.

http://www.ctmginc.com/

ABOUT OUR SPEAKERS:
Anton-Lewis Usala, M.D., CEO & Medical Director 

Dr. Anton Usala is CEO and Medical Director of CTMG, Inc.  He founded CTMG, Inc. to address the gaps in clinical trial quality systems he observed first hand first as a University Medical Center researcher, and later  when he directed the Biotech company he founded (Encelle, Inc.) into FDA monitored clinical trials. Dr. Usala is author of 17 U.S. patents, and has testified seven times before different U.S. Senate and House subcommittees on issues related to regenerative medicine.  While at his biotechnology company, Dr. Usala observed all facets of investigational product development are controlled by cGXP quality systems, except for the portion conducted in Physician Investigator sites.  While GCPs define what should occur, there are no operational systems to audit and correct deficiencies in an efficient time frame.  CTMG, Inc. is the first clinical trial management group that effectively brings experienced personnel with GMP-like systems into the Physician Investigator Offices. Dr. Usala received his undergraduate degree in Biology and Political Science from Swarthmore College, his medical Degree from Jefferson Medical College, and his pediatric and pediatric endocrinology training at Case Western Reserve University.

   
Christopher Hasty, M.D., Principal Investigator Researcher

Dr. Christopher Hasty received his undergraduate degree from UNC Chapel Hill, and his medical degree from Duke University School of Medicine.  He later did his orthopedic surgical residency at the University of Tennessee, as well as a fellowship in Orthopedic Trauma.    He is currently one of eleven orthopedic surgeons at Orthopaedics East, Inc., in Greenville, NC. Dr. Hasty had done basic science and engineering research, but had not been a participant in any clinical trials.  Given the high patient volume seen by himself and his colleagues, he conducted his first clinical trial utilizing CTMG’s CIMPS, and was the leading enroller (providing 15% of the patient data) for a Sponsored study involving growth factor injection into recent fracture sites.

 
Jeffrey Hoggard, M.D., Principal Investigator Researcher 

Dr. Jeffrey Hoggard received his undergraduate and medical degrees from UNC Chapel Hill, and his internal medicine and nephrology fellowship training at the University of Texas Health Science Center in San Antonio.  Dr. Hoggard is one of the Senior Partners of Eastern Nephrology Associates, which is the second largest nephrology practice in North Carolina.  Dr. Hoggard has been a successful clinical trial investigator for many years, and has given multiple presentations at national meetings.  Because of the large volume of patients seen at various Eastern Nephrology Associate locations, Dr. Hoggard began utilizing CTMG personnel and systems to manage his clinical trials, allowing his practice to double the number of active clinical trials being conducted at any time.  Dr. Hoggard also serves on multiple Hospital, Dialysis Center, and Kidney Foundation Committees.

   
Mark Cervi, M.D., Principal Investigator Researcher

Dr. Mark Cervi is Founder and President of Carolina Internal Medicine, a very busy Internal Medicine Practice located in Greenville, NC.  He is also a medical software inventor/developer and co-Founder of E-Flag.  Between 1999 and 2004, Dr. Cervi participated as a Principal or Sub-Investigator in ten Pharmaceutical Industry Sponsored Clinical Trials.  By the end of 2004, Dr. Cervi opted not to continue conducting clinical trials because of the economic and time impact on his Internal Medicine Practice.  In 2005, Dr. Cervi again conducted clinical trials, this time utilizing CTMG’s CIMPS, and is currently a high enrolling site for three clinical trials in the areas of hypertension and diabetes.  Dr. Cervi received his undergraduate degree in Biology from Virginia Tech, his Medical Degree from St. George’s University School of Medicine, and his internal medicine training at East Carolina University School of Medicine.

For information about the recorded archive for this event contact Xtalks at (416) 977-6555 ext 371, or email register@xtalks.com
 
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