Keynote Presentations at France and US Conferences
Tamera Norton Smith, PhD, MT(ASCP), President of Norton Audits, provided
keynote sessions at the Phoenix, AZ and Lyon, France Partnerships in Clinical Trials Conferences in
2011. Having filled in for a US Food and Drug Administration Representative at the Phoenix, AZ
Conference in March, Ms. Smith was also invited to speak at the Lyon, France Conference in
November, 2011. Ms. Smith's keynote sessions included 'Clinical Partnerships at a Crossroad; The
Intersection of Quality and Oversight' and 'What are Regulators' expectations of Vendor
Fifth Annual Auditing Forum a Success
Leveraging our highly successful four previous Auditing Forums and
continued International Auditing Experience, Norton Audits conducted our 5th Annual Auditing Forum
October 25-28, 2010 in Columbia, SC. Thirty-two students learned our proven Norton Methods for GCP
& ICH auditing of pharmaceutical and medical device investigators, sponsors, CROs and IRBs.
Lead by Norton Audits' President, former award-winning FDA Investigator and international auditor,
consultant and instructor Tamera Norton Smith, PhD, MT(ASCP), the Forum included case studies,
panel discussions, expert regulation knowledge and dynamic instruction. Additional Instructors from
Norton Audits included Compliance Analysts Deidra Poucher, Margo Holland and Cathy Metcalfe.
Attendees included students from Boston Scientific, Allergan, Medimmune, Symbio, Palmetto Health,
Marshfield Clinic, Sanofi Aventis, Georgia Health Sciences and Dana Farber Cancer Institute.
Norton Audits Partners for Asian Clinical Research Training
Effective March, 2011, Aklima Clinical Research, headquartered in Karachi,
Pakistan, will offer public training classes in clinical research utilizing Norton Training
Insitute training content along with Aklima training content and local Instructors within Pakistan.
While Aklima will market and conduct the training classes in Pakistan, the Norton Training
Institute will ensure proper GCP and ICH knowledge through overseeing student testing and issuing
final training certificates. Initial training programs to be offered by Aklima include the Norton
Training Institute's Clinical Research Associate (Monitor) Training Program and Clinical
Investigator and Coordinator GCP and ICH Training Program. Learn more about Aklima at
Norton Audits to Lead Oncology Research Program Re-Start
One of World's Largest Oncology Research Facilities Selects Norton Audits.
With honoring our confidentiality, nondisclosure and media restrictions, few direct specifics can
be provided on this endeavor including the name of this large oncology research facility. Norton
Audits is leading the review, audits, training and advisement in re-opening one of the world's
largest sponsor, government, investigator-initiated and grant-based oncology research facilities
located in the US. After voluntarily idling enrollment and on-going research due to systemic Good
Clinical Practice (GCP), International Conference on Harmonisation (ICH E6), 21 Code of Federal
Regulations (US FDA) and many other regulatory body noncompliance concerns at their facility,
Norton Audits was selected to conduct up to approximately 80 Investigator audits to assess these
systemic concerns and individual Investigator performance. Relying on our extensive systems,
auditing and risk management knowledge and experience, Norton Audits will complete these audits in
approximately February, 2011 and then initiate further follow-up consulting and training.
Fourth Annual Auditing Forum a Success
Leveraging our highly successful three previous Auditing Forums
and continued International Auditing Experience, Norton Audits conducted our 4th Annual
Auditing Forum October 19-22, 2010 in Orlando, FL at the Hilton Walt Disney World
Resort. Thirty students learned our proven Norton Methods for GCP & ICH auditing of
pharmaceutical and medical device investigators, sponsors, CROs and IRBs. Lead by Norton
Audits' President, former award-winning FDA Investigator and international auditor, consultant and
instructor Tamera Norton Smith, PhD, MT(ASCP), the Forum included case studies, panel
discussions, expert regulation knowledge and dynamic instruction. Additional Instructors from
Norton Audits included Melissa Pong, Compliance Director, Deidra Poucher, Regulatory Director and
Margo Holland, Sr. Compliance Analyst. Attendees included students from ICON, Boston
Scientific, Vanderbilt, Boehringer Ingelheim and Dana Farber Cancer Institute.
Norton Audits Adds Monitoring Audits Services
Monitoring Report Reviews and On-Site Monitor Audits Completed for First
As part of approximately 24 international oncology investigator audits, Norton Audits
completed approximately 75 Investigator monitoring report reviews to identify study noncompliance
trends and to identify high risk Investigators to audit. For each Investigator on the study, Norton
Audits reviewed all monitoring reports and completed a simple one-page review document complete
with ratings and comments that were easily compiled into an overall Investigator risk assessment.
As part of a separate project, Norton Audits visited several Investigator sites to audit the
monitoring conducted at that site against the protocol requirements, 21 CFR requirements and the
sponsor SOPs and policies.
Third Annual Auditing Forum a Success
Our Third Annual Auditing Forum was held in San Francisco, CA
March 2-5, 2010. 3 1/2 days of Clinical Investigator auditing training including a 2-day
Auditing Fundamentals Session and 1 1/2-day Advanced Auditing Topics Session were attended
by 18 research professionals from the US, Canada, Hong Kong and Japan including Sr.
Monitors, Auditors and Management from Sponsors, CROs, Universities and Research Sites. Lead
by Company President Tamera Norton Smith, PhD, MT(ASCP), this Forum included case studies, panel
discussions, expert regulation knowledge and dynamic instruction. Other Instructors from
Norton Audits included Melissa Pong, MS, CCRA, Director of Compliance and Deidra Poucher, BSN, RN,
MSHS, CCRC, Regulatory Director.
Clinical Investigator Mentoring Client Wins First Studies
After failing to obtain any studies from an external study placement
consultant in 2008, Piedmont Health Group in Greenwood, SC was awarded three studies
that initiated in early 2010. Piedmont Heatlh Group engaged Norton Audits in March, 2009 to
implement Standard Operating Procedures, clinical research team training, on-site facilities
consulting and winning study assistance. Since March, 2009, Piedmont Health Group has hosted
Sanofi-Aventis, Merck, Bristol Meyers, GSK and i3 Research for Qualification Visits and were
awarded three studies in November, 2009. We congratulate Piedmont Health Group on this initial
success. Learn more about them at
Sponsor Contract Auditing Services Increase
Leveraging our expertise and reputation for unique and effective
auditing services, several Sponsor organizations have engaged Norton Audits to provide contract
auditing services to meet their on-going clinical research needs during this transitionary economic
period. These organizations include large international and mid-size US-based firms conducting
research in medical devices and pharmaceuticals. Contact Norton Audits at
email@example.com to make your inquiry for similar auditing services.
First Annual Auditing Forum a Success
Our First Annual Auditing Forum was held in Columbia, SC October
7-10, 2008. 3 1/2 days of Clinical Investigator auditing training including a 2-day Auditing
Fundamentals Session and 1 1/2-day Advanced Auditing Topics Session were attended by 27 research
professionals from the US and Canada, including Sr. Monitors, Auditors and Management from
Sponsors, CROs, Universities and Research Sites. Lead by Company President Tamera Norton
Smith, PhD, MT(ASCP), this Forum included case studies, panel discussions, expert regulation
knowledge and dynamic instruction. Other Instructors from Norton Audits included Melissa Pong,
MS, CCRA, Director of Compliance and Deidra Poucher, BSN, RN, MSHS, CCRC, Regulatory
Norton Audits Launches Second Customer-Specific On-Line Training Portal
Having demonstrated the ability to provide on-line training to the
Clinical Research Industry at large since 2005, Norton Audits has commissioned its second
customer-specific on-line training portal for 25 Clinical Research Coordinators and Investigators
at the Washington University Sleep Medicine Center (http://washusleepresearch.coursehost.com). This
on-line training portal will provide education on 25 Standard Operating Procedures, also provided
by Norton Audits, and their associated Good Clinical Practices to Washington University. The
advantages of the dedicated on-line training portal for this client include a custom home page with
customer-specific graphics, logos, color and text, the ability to load custom training content,
complete hosting and administrative services from Norton Audits, and unique reports of the training
status and completions of the students. Contact Norton Audits for information on how we can do the
same for your research organization and visit our Public On-Line Training Offering at
Norton Audits Speaks at Second Annual FDA Inspections Summit
Tamera Norton Smith, PhD, MT(ASCP), President and Senior
Consultant of Norton Audits, Inc. and former FDA Investigator, spoke at the Second Annual
FDA Inspections Summit entitled "Getting it Right the First Time, Every
Time". Held October 22 thru 24, 2007 in Washington, DC, Ms. Smith presented "Upfront GCP Compliance: Understanding
Risk Mitigation for Successful FDA and Business Outcomes".
Norton Audits Featured in 'The Monitor'
Recognizing Norton Audits’ 4
th year of contributing to the Annual ACRP Global Conference through a full-day
Workshop, ‘The Monitor’ sites our ‘Compliance Practices: Advanced Auditing Skills for Monitors and
Auditors’ as a “traditionally popular advanced level workshop” that “targets the nitty-gritty
details of hands-on, skill-based auditing techniques in concert with strict adherence to good
clinical practice and ICH”. This workshop was led by Tamera Norton Smith, PhD and President of
Norton Audits and complimented by significant contribution from Melissa Pong, MS, CCRA and GCP
Specialist for Norton Audits. Read the entire article on page 4 of ‘The Monitor’ June 2007
Special Supplement for Highlights from the 2007 Global Conference & Exhibition.
Norton Audits Presents at DIA 2007 Annual Meeting
Tamera Norton Smith, PhD, and Angelo Sambunaris, MD and Medical Director of The Atlanta
Institute of Medicine & Research presented "Emergency Procedures for when a Sponsor Goes Bad"
on June 19, 2007 at the DIA (Drug Information Association) 43rd Annual Meeting in Atlanta,
Georgia. As part of this Session, Ms. Smith also presented "Developing a GCP Strategy for
Protecting Your Clinical Research Site".
Norton Audits to Present at ACRP 2007
For the fourth consecutive year,
Tamera Norton Smith will lead two high-energy skill-focused presentations including Concurrent
Session ‘How to Audit CROs and Sponsors’ and all day Workshop ‘Compliance Practices: Advanced
Auditing Skills for Monitors and Auditors’. Ms. Smith will be joined by Co-Presenter Melissa
Pong, BS, MS, CCRA, Auditor and GCP Specialist from Norton Audits. Find further information on the ACRP Conference at
Norton Audits Launching First Customer-Specific On-Line Training Portal
Having demonstrated the ability to provide on-line training to the
Clinical Research Industry at large since 2005, Norton Audits has commissioned it's first
customer-specific on-line training portal for 100 Clinical Research Coordinators, Investigators,
Project Managers, and other Research Professionals at a large Research Hospital in Pennsylvania.
These 100 Professionals represent 13 unique therapeutic areas, for whom Norton Audits is also
deploying a common set of Research Standard Operating Procedures. The on-line training portal will
provide training on these 25 SOPs as well as general Good Clinical Practices and in the near-future
custom training programs will also likely be deployed for this client. The advantages of the
dedicated on-line training portal for this client include a custom home page with unique graphics,
logos, and text, the ability to load custom training content, complete hosting and administrative
services from Norton Audits, and unique reports of the training status and completions of the
students. Contact Norton Audits for information on how we can do the same for your research
organization and visit our Public On-Line Training Offering at
Existing Device Sponsor Customer Sends 10 CRAs to 2/07 Public Training Class
After utilizing Norton Audits for several in-house custom training classes,
including 'Monitoring Through Quality Systems', a large Device Sponsor has committed to send 10 of
their new CRAs to Norton Audits' next 3-day Monitoring of Clinical Investigators Training Class to
be held February 20 - 22, 2007 in Columbia , SC. Previously this Device Sponsor has utilized
a large well-known national training company for their entry-level CRA training, but turned to
Norton Audits for their up-to-date, regulation and skill-focused training format that includes
real-world case studies from Norton Audits Auditing and Consulting Services. Learn more about
and join us for this next Monitoring of Clinical Investigators Class at
Is Clinical Trial Noncompliance Allowed to Happen?
Tamera Norton Smith, President and Senior Consultant at Norton Audits, Inc.
will lead an Audio Conference on Friday, October 27, 2006 on "Is Clinical Trial Noncompliance
Allowed to Happen?" .
This Audio Conference will help you
learn how to demonstrate voluntary compliance and determine how to be in a constant audit
ready-state. Each research professional has the responsibility to ensure
compliance is maintained throughout the clinical trial process. The monitoring and auditing process
is pivotal in this assessment. Are monitors and auditors empowered to help gain compliance? What
are the necessary skills for helping each professional understand their legal and regulatory
obligations? Since compliance is a prospective process and not retrospecitve, Dr. Smith's
presentation will also focus on steps and programs to ensure compliance as well as key pertinent
regulations that focus on securing compliance.
Norton Audits Chairs 3rd Annual 'Sustaining FDA Compliance' Conference
Tamera Norton Smith, President and Senior Consultant, presented a
Pre-Conference Workshop on 'Risk Management - Proactive Compliance Strategies for Corporate and FDA
Sucess' and chaired this 2-day Executive Conference. Ms. Smith is a former FDA Investigator
that has conducted 100s of FDA Audits herself, as well as 100s more of Mock FDA, For Cause,
and Proactive Risk Analysis Audits for Pharmaceutical, Medical Device, and Biotech
Sponsors, CROs, and Clinical Investigators. Joining Ms. Smith in the Workshop was
Jonas Berwick, President of Delve Information Resources, a strategic partner of Norton Audits, Inc.
who will spoke on company and individual background checks, investigations, and
lost-to-follow-up services as part of research risk mitigation. Learn more about this
value-rich conference at
by contacting Norton Audits at
Norton Audits Presents at ACRP 2006 Global Conference
For the third consecutive year,
Tamera Norton Smith lead two high-energy skill-focused sessions including the CRA Forum
Session on 'Effective Auditing Skills and Techniques for Monitors' and an all day Workshop on
'Advanced Clinical Trial Compliance Practices'. In addition, Ms. Smith presented a Poster on
'Defining and Examining Clinical Trial Noncompliance'.
Norton Audits Leads ACRP Audio Conference March 17, 2006
'Ensuring Drug Safety and Human Subject Protection' was presented byTamera
Norton Smith, which focused on the necessary skills and understanding of the regulations that
define the role of the Monitor.
Norton Audits to Provide Subject
Lost to Follow-Up Services
with Investigator and other Personnel Background Checks, and Subject Recruitment Database Searches,
Norton Audits has partnered with Delve Information Resources of Lawrenceville, GA to provide this
new and risk mitigating service to the Clinical Research Industry. Delve Information
Resources is a leader in the legal, financial, and insurance industries for providing these same
services and has recently provided Subject Lost to Follow-Up services for Duke and Emory
Universities. Contact Norton Audits for more information.
Norton Audits Conducts Auditing Training in Canada
Val Willets and Les Gee from ASKA Research
in Vancouver, British Columbia invited and hosted thirteen Monitors,
Coordinators and Auditors from their network of Clinical Research Professionals for a two-day
Auditing Clinical Investigators Training Class presented by Tamera Norton Smith, PhD and President
of Norton Audits, Inc. This training class represents one of the first partnerships
Norton Audits has created with a complimentary Clinical Research Organization, such as ASKA
Research, to bring our proven and unique Auditing techniques to new geographic areas of the
clinical research industry. While Norton Audits continues to conduct Public Training Classes
at its headquarters in Columbia, SC, Norton Audits will continue to partner with
other research organizations to present live Public Training Classes for Auditors, Monitors,
Coordinators, Investigators and others within their geographic locales.
Norton Audits Trains FDA
Norton Audits, Inc. (NAI); a clinical research auditing, training, and consulting services firm
located in Columbia, SC, provided their Norton Method for conducting 'Scientific
Investigations: Complaint Management and Advanced Interviewing Skills' training class for
the United States Food and Drug Administration Center for Devices and Radiological Health’s
(CDRH) Division of Scientific Investigations in June, 2005 . This customized training
program took place in Rockville , MD and was the second such training
program conducted by Tamera Norton Smith, President, Norton Audits, Inc. for the FDA’s
Columbia , SC (PRWEB)
May 4, 2005 - The FDA’s Center for Devices and Radiological Health (CDRH) is responsible for
overall product approval, product safety, consumer protection, and oversight of biomonitoring
activities for all medical device products approved by the FDA. Norton Audits’ selection was based
on fifteen years of clinical data auditing expertise, unyielding compliance law experience,
national training reputation, and regulatory case development skills in both the medical device and
Additionally, Norton Audits announced preparations for Tamera Norton Smith to jointly present
with the U.S. FDA at the 2006 Association of Clinical Research Professionals (ACRP) National
Conference to be held in Phoenix , Arizona . The Center of Devices and Radiological Health has set
the topic for 2006 to address Quality Systems in Clinical Trials.
About Norton Audits, Inc.:
Norton Audits’ mission continues to focus on advancing clinical research through strategic
systems development and implementation for defining and driving performance excellence. Norton
Audits’ most successful product is their skill set for identifying and helping their clients
proactively identify and limit their risk that would prevent an approval of a New Drug Application
and Medical Device Pre-Market Application. Norton Audits provides auditing, monitoring, consulting
and training services and products to the Clinical Research Industry. Norton Audits, Inc. is also a
member of the University of South Carolina Technology Incubator .
Norton Audits Presents at ACRP Global Conference
Norton Audits Chairs 3rd Annual 'Sustaining FDA Compliance' Conference
Is Clinical Trial Noncompliance Allowed to Happen? -
Join Norton Audits President in Audio Conference Presentation
Norton Audits Leads ACRP Audio Conference
Clinical Investigator Mentoring
Customer Wins First Study
Dr. Robert Earle and Lynda Barker,
ANP, of Bay Area Psychiatry won their first Clinical Trial Study from ICON and AstraZeneca
approximately two months after completing a 2-day intensive Mentoring Session with Norton Audits,
Inc. Norton Audits provided specific training and guidance in Clinical Research Site
Operations, including Good Clinical Practices, how to obtain studies and implementing several
Norton Audits Site Standard Operating Procedures. Norton Audits also supported Bay Area
Psychiatry in their on-going applications for study trials and Site Qualification Visits. We
congratulate Bay Area Psychiatry in winning their first study.
This two-day conference from Insight Information addresses the
day-to-day challenges faced by the Canadian pharmaceutical sector. Norton Audits to
speak on 'Emerging Compliance for Multi-Jurisdictional Concurrent Clinical Trials'.
Norton Audits 'Clinical Trials Administrator' Article:
'Deal with NonCompliance before it reaches the FDA' includes Two Corrective
In the July 2005 Issue of 'Clinical Trials Administrator', published by
Thomson American Health Consultants, Tamera Norton Smith, President and Sr. Consultant for Norton
Audits, Inc., discusses the main causes of and five preventative steps for research
noncompliance. Ms. Smith states that "The main causes of research noncompliance result from
investigators, research staff, and industry sponsor staff misunderstanding or having difficulty
This article includes five recommended steps for achieving regulation
and protocol compliance, that revolve around SOPs, training and corrective actions, including two
corrective actions forms. To view this article in full, please visit the Thomson American
Health Consultants web site at
http://www.ahcpub.com/online.html and search
for the July 2005 Issue of 'Clinical Trials Administrator'. You will need to have or estabish
an account with Thomson to view the article in full.
Norton Audits Fraud Mentoring Session
"I have to tell you, we are SO grateful for the tools and training that
you gave us I can't even begin to tell you! We have implemented several of your tools into
this project. We put together an action plan that we has been complemented on by numerous
seasoned veterans on our team. Due to some contractual logistics, we had to move back our
arrival date of this "mission", so our first day in is tomorrow...... I will keep you updated
as to our progress and may call on you if necessary for some more of your expertise. We could
not have even made it this far without you!!"
Lead Clinical Research Associate II
Norton Audits Auditing Mentoring Session
"Tamera's one-on-one mentorship provided me with more insight than years
of training sessions could have. Her in-depth, first-hand knowledge of the FDA
regulations and practical approach to monitoring and auditing goes unmatched by any other in the
industry. Her calculated organization and personally devised
tools for employee training programs and site SOPs provided me with resources that would have taken
years to compile. I only wish I would have met her years ago!"
Dana M. Wentzel,
RN, MSHSA, CCRC
Director of Clinical Research
Lehigh Valley Hospital
ACRP 2005 Conference & Exhibition
Norton Audits Speaks at ACRP 2005 Conference & Exhibition North America in Orlando, FL April
Tamera Norton Smith, President and Senior Consultant of Norton Audits, Inc. and Guest
Speaker Dr. Angelo Sambunaris, President and Medical Director of the Atlanta Institute of
Medicine and Research, conducted a very well received full-day ‘Compliance Practices for
Clinical Research Professionals’ Workshop for fifty Clinical Research Professionals.
In addition, Tamera Norton Smith, conducted a two-hour Clinical Research Associate Forum
Discussion on 'Monitoring Compliance through Quality Systems' for approximately 150 ACRP members,
where attendees described Ms. Smith's presentation as "truly a breath of fresh air in the
monitoring world of sameness" and "I was inspired again after your presentation in a way
similar that got me into this field in the early 80s".
Norton Audits, Inc. is again planning to speak at ACRP2006 in Phoenix, AZ, which will mark our
third consecutive year of advancing the body of knowledge within the Association of Clinical
Research Professionals Community.
National Training Center Opens
Norton Audits opens their National Training Center in Columbia, SC. Classes begin June, 2005.
See our Training Section for more details.
Norton Audits to Speak at 'Clinical Trials in Canada'
Tamera Norton Smith, PhD, MT(ASC), President and Senior Consultant of
Norton Audits, Inc. and former FDA Investigator, presented at the Second Annual FDA Inspections
Summit entitled "Getting it Right the First Time, Every Time". Held October 22 thru 24, 2007
in Bethesda, Maryland, Ms. Smith presented on "Upfront GCP Compliance: Understanding Risk
Mitigation for Successful FDA and Business Outcomes".