Formally incorporated in 2000, Norton Audits, Inc., abbreviated NAI, represents our commitment to helping your organization achieve ‘No Action Indicated’; a US Food and Drug Administration term for full compliance with regulatory requirements and an indication of minimal risk for protocol failure or patient safety in your clinical research activities.

Our People

Clinical research experts that are grounded, trained and field-experienced in regulatory law and the real world application of industry compliance policies, procedures and activities. Some of our consultants are former award-winning FDA Investigators that are regulation experts providing proper interpretation and working knowledge of regulations.   All of our consultants have field experience in achieving protocol and regulation compliance for Sponsors, CROs, IRBs and Clinical Investigators.

Tamera Norton Smith, PhD, MT(ASCP)

Tamera Norton Smith, Ph.D, MT(ASCP) is President and Senior Consultant for Norton Audits, Inc.  She has twenty years of U.S. Food and Drug Administration and Clinical Research pharmaceutical, medical device, and biotechnology experience.  As a former U.S. Food and Drug Administration Investigator, she won several awards for casework related to Good Clinical Practices, Good Manufacturing Practices, Biologics, and Fraud Detection.  As a major US Sponsor Senior Clinical Research Associate she monitored world-wide trials and developed training programs in fraud detection and monitoring processes in general.  Ms. Smith founded Norton Audits, Inc. in 1999 and is currently an active auditor, author, consultant, national speaker, and trainer throughout the pharmaceutical, medical device and biotechnology industries.

Jeff Smith, BS, MBA

Jeff Smith, BS, MBA, is Vice President for Norton Audits, Inc. leading customer service, project management, marketing, and operations activities.  Jeff brings twenty-one years of project management experience from the clinical research, manufacturing and sales/marketing industry, along with extensive knowledge in software, customer service, and engineering.  In addition, he has experience in several regulated industries, including clinical research, from which a strong understanding of Quality Systems and Proactive Processes has been developed. 

Melissa Pong, MS, CCRA

Melissa Pong, MS, CCRA, and Compliance Director for Norton Audits is a Sr. Auditor, Instructor, and GCP Specialist for Norton Audits, Inc.  She has 15 years experience as a Clinical Research Associate, Research Lab Technician, and Consultant with several large pharmaceutical firms including Corus Pharma, Inc., ICOS Corporation, PAREXEL International, Abbott Laboratories, Rush Cancer Institute and IIT Research Institute.  Ms. Pong’s career achievements include managing and auditing several clinical trials in many therapeutic areas including Ophthalmology, Urology, Osteoarthritis, Oncology, Cardiovascular, Infectious Disease, OBGYN, Pain Management, and Respiratory.

Deidra Poucher, BSN, RN, MSHS, CCRC