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Norton Audits Government Research Opportunities
08.10.2015
To Leverage our Recent Government Experience
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Norton Audits Capabilities Statement
04.17.2015
In support of U.S. Government requests, 2015 Cap Statement released
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Our Name


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.

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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.

 

Jeff Smith, BS, MBA

 

Jeff Smith, BS, MBA, is Vice President for Norton Audits, Inc. leading customer service and compliance project management, as well as conducting compliance audits.  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. 

 

Alaina Barros, BS, MT(ASCP), CCRA

 

Ms. Barros, Compliance Director for Norton Audits is a Principal Compliance Analyst and GCP Specialist with thirteen years of research experience as an international auditor, consultant, monitor and Quality Assurance manager. Prior to her research experience, Ms. Barros functioned as an engineer and developed a strong background in quality systems.  Ms. Barros' therapeutic experience includes cardiovascular, pain, radiology, oncology, hematology, CNS, immunology, infectious disease, musculoskeletal, respiratory, gastrointestinal, and septic shock among others.
Cathy Metcalfe , RN, BHS, CCRA, CCRC
Ms. Metcalfe is a Principal Compliance Analyst with twenty-one years of research experience as an international auditor, monitor, clinical research coordinator and instructor. Ms. Metcalfe has audited in many countries, including but not limited to Russia, Ukraine, Israel, England, Germany, Brazil and Mexico, along with all of North America.  Prior to her direct research experience, Ms. Metcalfe functioned in various hospital settings as a nurse and therefore has a strong background in medical services.  Ms. Metcalfe's therapeutic experience includes cardiovascular, pain, radiology, oncology, ENT, endocrine, OBGYN, hematology, CNS, immunology, infectious disease, musculoskeletal, respiratory, gastrointestinal, and septic shock among others.
 

Other auditors include Rachel Addison, MS, MS, CCRA and Paula Hamilton, BA, CQA, CCRA, plus a network of contract auditors


 
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