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 sixteen 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 18 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.
James Robinson,
BS
James
Robinson, BS, is a Senior Auditor and Consultant for Norton Audits, Inc. He has 28 years experience as an
award-winning Senior Investigator for the U.S. Food and Drug Administration,
along with significant experience as an independent industry auditor. Throughout his career with the FDA, he
was awarded several Exceptional Performance Awards as well as awards for
completing four high priority volatile BIMO Inspections in
South
Africa.
Mr. Robinson’s international and US-based experience in pharmaceutical,
medical device and biotech therapeutic areas is extensive and includes OBGYN,
Ophthalmology, Oncology, Dental, Diabetes, Infectious Disease, Gastrology,
Pediatric, Dermatology, Osteoporosis, Cardiology, and Arthritis.
Melissa Pong, MS,
CCRA
Melissa Pong,
MS, CCRA, is an Auditor, Instructor, and GCP Specialist for Norton Audits,
Inc. She has over 14 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.
Roberta Smith, AS
Roberta
Smith, AS, is
the Technical Writer for Norton Audits, Inc. bringing her 16 years of graphic
art and communication skills to developing effective training programs for CRAs,
Auditors, Coordinators, Investigators, and all Clinical Research
Professionals. Combined with the
over 50 years of research experience within Norton Audits, Ms. Smith creates
graphic, audio, and text-based training materials that are deployed in on-line
web-based training programs, manuals, and live training class materials. Ms. Smith also
oversees the processing of customer orders for customized Standard Operating
Procedures for Investigators, CROs, IRBs, and
Sponsors.
