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
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.
Deidra Poucher, BSN, RN, MSHS, CCRC, RQAP-GCP
Ms. Poucher, BSN, RN, MSHS, CCRC and Regulatory
Director for Norton Audits is a Sr. Auditor, Instructor and GCP Specialist with seventeen years of
research experience as an international auditor, consultant, instructor, IRB member, study
coordinator and research nurse, plus sixteen years of nursing experience. Ms.
Poucher's experience includes IRB Surveyor, Adjunct Professor, ACRP Chair and Regulatory
Affairs. Ms. Poucher’s therapeutic experience includes cardiovascular, pain, radiology, ophthalmology,
oncology, vascular, hematology, CNS, immunology, infectious disease, musculoskeletal, urinary,
OBGYN, respiratory, organ transplant and critical care among others.
Other full-time Auditors include Margo Holland, Cathy Metcalfe, Rachel
Addison and Alaina Barros, plus a network of contract auditors