Norton Audits serves a full range of
clinical research clients including Sponsors, Contract Research Organizations (CROs), Institutional Review Boards (IRBs),
Clinical Investigators (Sites) and Independent Clinical Research Associates (CRAs), as well as
the US Food and Drug Administration itself. We
strive to define a proper solution to our client's
needs upfront to ensure customer satisfaction and continued safe and effective clinical research.
Here a just a few examples of the needs we have met and customer
relationships we have built.
Lehigh Valley Hospital
Institutional Clinical Research Organization, Allentown, PA
- In February, 2005, Dana Wentzel, Director of Clinical
Research at Lehigh Valley Hospital, was seeking to advance her organization's
ability to monitor its Investigator-Initiated Trials as well as audit all
internal trials and research activities. Upon learning of Norton Audits'
expertise in auditing and the monitoring process from a colleague, Ms. Wentzel
engaged Norton Audits for a two-day Mentoring Session along with her
Primary Clinical Investigator. Upon completing this auditing and
monitoring mentoring session in March, 2005 at the office of one
of Norton Audits' Clinical Research Customers, in order to provide
hands-on real-world research exposure to Ms. Wentzel and her Investigator, Ms.
Wentzel was on her way to successfully preparing her internal monitoring and
- Based on the successful 2005 Mentoring Session, Lehigh Valley has engaged
Norton Audits to lead a Clinical Research Retreat in April, 2006, to be
attended by the majoriy of Lehigh Valley's research staff, where further
education and advisement on how World-Class Research Institutes operate
will be provided by Norton Audits, Inc.
Bay Area Clinical Services
Robert N. Earle, MD, Clinical Investigator, Houston, TX
- Upon deciding to add clinical research services to
his existing successful psychiatric practice, Dr. Earle and his Nurse
Practioner searched for a company that could provide training, procedures, and
advisement in setting up their research services and successfully
obtaining their first research trial. In Norton Audits, Inc., Dr. Earle
found a company that could provide just that in a simple, effective, yet
highly professional manner.
- Dr. Earle and his Nurse Practioner/Study Coordinator
attended a two-day Mentoring Session with Norton Audits in August, 2005,
where they learned the regulatory laws, guidelines and proven skills to obtain
and conduct clinical research studies. They also received an initial
compliment of five SOPs to control their core research procedures.
- After providing further advisement on how to set up
their research facility and answer certain questions from prospective CRO
and Sponsor customers looking to place studies with them, Dr. Earle
was awarded his first research study in October, 2005, just two months
after his initial training with Norton Audits.
- Norton Audits continues to provide advisement and consultation to Dr.
Earle and his Study Coordinator on questions and issues that arise with their
research customers, as it is important to gain the independent and
regulatory-based advisement that Norton Audits can provide and not to solely
follow the directions of the CRO or Sponsor organization.
Neurodiagnostic Accessory Manufacturer, Columbia, SC
- In September, 2004, Norton Audits conducted a two-day
Mock FDA and Risk Assessment Audit of Rhythmlink's engineering, manufacturing,
and distribution processes at their Columbia, SC plant. This Audit
identified findings and recommendations for improvement in the areas of
product marketing collateral with regard to the use of the term "FDA
Approved", the need to implement a product consumer complaint handling system,
the need to implement a Medical Device Report System for reportable events,
expanding their Corrective and Preventative Actions System for non-reportable
events, adding Management Controls with regard to internal auditing,
and product storage and separation improvements. This Audit
also identified several strengths of Rhythmlink, including their
extensive and detailed Standard Operating Procedures, personnel training, and
general facility cleanliness and order. As part of this Audit,
Rhythmlink management and personnel were also instructed in how to conduct
themselves during an FDA Audit, including how to answer questions, provide
requested information, providing escort for the FDA Investigator, the likely
notification process by the FDA that an Inspection is upcoming, and the
suggestion to prepare an FDA or Outside Organization Audit Standard Operating
Procedure. Rhythmlink's Management was very committed to understanding
and addressing all of the Audit findings and recommendations for improvement.
- In October, 2005, Rhythmlink was advised by the FDA
of an upcoming on-site inspection. After a brief refresher phone
call with Norton Audits on how to properly receive and conduct this FDA
Inspection, Rhythmlink successfully passed the FDA Inspection with no findings
or FDA Form-483.
- Rhythmlink is to be commended for Building in Compliance through their
Proactive Philosophy with regard to implementing procedures and processes that
are in full regulatory compliance before they conduct business and
not reactively after problems are identified through customer feedback or
audit findings. Rhythmlink's investment in a Mock FDA Audit with Norton
Audits certainly paid dividends in their successful FDA Inspection, as well as
in their continued engineering, manufacturing, and distribution of safe
and effective products.