"I cannot tell you how much I appreciate all of your help in making
our training a success! I did not hear a single negative comment or suggestion….nothing but
positive feedback and enthusiasm about the day (which is rare in a group this size).
Sr. Clinical Research Associate from in-house Monitor Training Class,
September 2008
"I just wanted to thank you for the GCP presentation which you gave for our group at
Washington University. I was so inspired by your talk that I have started a quality
improvement process with the coordinators with whom I work. In addition to our IRB’s
guidelines and HHS/OHRP Guidance, we are reviewing the wonderful notes and tools that you shared
with us at the GCP presentation. We have written our first SOPs focusing on submission of AEs,
SAE, and INDs/Medwatch Reports. I believe that we are improving the process.
I hope that we can invite you back one day. If you are presenting in our area and it is
open to outsiders, I would love to attend. Thanks again!!
Clinical Research Coordinator from in-house GCP Training Class,
August 2008
"Great Speaker. Phenomenal.
Wow! An entire new arena of information for me. New doors opened for continued
education. Very well done and received by the group. I've attended training in the past
and I think this trainer is excellent."
Investigators and Coordinators, from 'Clinical Investigations and the FDA Inspectional
Process' On-Site Class, August 2006
"This training will help give me more of a
clear base or foundation to continue my learning on becoming a good CRC."
Clinical Research Coordinator from 'Promoting Excellence in
Clinical Research' Class, January 2006
"I have considered using Norton Audits for
consultation in the past, now enthused!"
Independent Clinical Research Professional, from 'Auditing
Clinical Investigators' Class, January, 2006
"
This class confirmed that a systems approach
to evaluating the site/sponsors/data/staff/etc. provides a greater sense of reliability of subject
safety."
Independent Clinical Research Professional, from 'Auditing
Clinical Investigators' Class January, 2006
"I have a whole new outlook on my job.
In a way it is scary! I hope I can make a difference in the future as to how things are being
done."
Regulatory Compliance from 'Promoting Excellence in Clinical
Research' Class, January 2006
“This training will provide a stepping-stone
for clinical auditing that I will be asked to do in the future.”
Quality Assurance Manager from 'Clinical Research Fraud and
Misconduct' Class, December, 2005
“This training has opened my eyes! I now know that the Sponsor does not provide all the
necessary “tools” needed for ensuring data collection/management. I have to do more to protect/cover myself.”
Community Research, Study Coordinator from 'Clinical Research
Fraud and Misconduct' Class, December, 2005
“I will be a better monitor since my auditing
skills have been improved by this knowledge based/experience based presentation. Every CRA, Sponsor, Investigator, and site staff
should participate in these classes! We want more!”
CSMG, Clinical Research Associate from 'Monitoring through Quality
Systems' Class, November, 2005
“Increased awareness on approaching
preparedness for sites prior to study start-up. Evaluate and pre-study sites that lack critical
elements for performing research.”
CSMG, Clinical Research Associate from 'Monitoring through Quality
Systems' Class, November, 2005
“Everything you offer is great, emails and
forms to come are great, further training classes desirable”
From “GCP-Coordinator/Monitor' Class, September, 2005
“I will be paying close attention to the
protocol and making sure that the PI is available for the study subject questions and concerns.”&
amp; lt; /span>
From 'GCP – Coordinator/Monitor' Class, October, 2005
"This training will help us win more
studies."
Study Coordinator from 'Promoting Excellence in Clinical
Research - Study Coordinator' Training Class, September, 2004
"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."
Lead Clinical Research Associate II, OrthoLogic Corp., from 'Clinical Research Fraud and
Misconduct' Mentoring Session, July, 2005
"We thoroughly enjoyed and valued our time and
information received from Tamera."
Senior Clinical Research Associate, Guidant Corporation, from In-House 'Monitoring through
Quality Systems' Training Class, May, 2005
"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!"
Director of Clinical Research, Lehigh Valley Hospital, from
Two-Day One-on-One Mentoring Session, March, 2005
"Every time I have heard your presentations,
you have given me new life."
Senior Clinical Research Associate, Novartis, North Texas ACRP Seminar, October, 2004
"This was an excellent course. Ms. Smith
is extremely knowledgeable in the area of fraud and held the attention of the audience the entire
day. "
Clinical Research Associate, Aventis, from 'Detection and
Prevention of Clinical Research Fraud and Misconduct' Training Class, September,
2004
"Your FDA and industry experience, and
systematic approach to regulations and real world clinical research issues continues to make us a
better organization."
Psychiatric Clinical Investigator, Atlanta Institute of Medicine and Research, from
in-house Coordinator Training Class, October, 2004
"I gathered a lot better data than I would
have before your talk."
Clinical Research Coordinator, North Texas ACRP Seminar, October, 2004
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