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Norton Audits Completes 5 Year Sepsis Study Auditing Contract
09.10.2017
18 Audits Conducted from 2011 through 2017
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Norton Audits Completes Investigator Systems Consulting
05.22.2017
Focus in Quality and Marketing Leads to New Business Model
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Customer Case Studies


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 auditing processes.
  • 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. 

Rhythmlink International

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.

 
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