Home About NAI Professional Services Products Ask the Expert Contact Us
  Overview
  Auditing
  Consulting
  Publications
  Clinical Investigator Services
  Training Overview and Options
  Audio Conferences
  On-Line Training
  Mentoring Training
  Public Training Classes
  On Site Training

Fourth Annual Auditing Forum Scheduled
07.19.2010
Oct. 2010 Orlando, Expert Techniques, Panel Discussions and Case Studies Presented
(More)
Norton Audits Adds Monitoring Audits to Services
05.14.2010
Monitoring Report Reviews and On-Site Monitor Audits Completed for First Clients
(More)

Independent GCP Auditing:

Proactive Risk and Compliance Audits of Your Protocols, Procedures and Activities


Similar to our clients, our Auditing Goal is to Protect Human Subjects while achieving Clinical Trial Product Safety and Efficacy Objectives. We accomplish this through Quality Systems-Based Audits (not just simple checklists) that focus on proactively identifying the risks and non-compliance that compromise patient safety and product efficacy. Whether auditing against your Protocols or Standard Operating Procedures, Industry Standards or Regulatory Laws, NAI independently assesses your compliance level while also providing valuable recommendations for improvement.

Our Auditing Experience represents the three primary sides of Compliance:
  • The US Food and Drug Administration – Consumer Safety Officers
  • Major US Pharmaceutical Manufacturer – Senior Clinical Research Associates
  • Independent Auditors – Having completed 100s of Sponsor, CRO, IRB and Investigator GCP Audits

Our Auditing Techniques and Scope Include:

  • Data Trending
  • Anchoring
  • Informed Consent   
  • Training Records
  • Regulatory Documents
  • Case Report Forms
  • Facility Inspection
  • Record Storage
  • OSHA Requirements
  • Mock FDA Audits
  • Assessing Monitoring Effectiveness
  • Source Documentation
  • Adverse Event Reporting
  • Drug or Device Accountability
  • Protocol Violations and Waivers
  • Clinical Investigator Oversight
  • IRB, Sponsor and CRO Communication
  • Laboratory Data Collection Process
  • Financial Disclosure Requirements
  • Regulations and Standards Including


Our Auditing Deliverables Include:
  • Audit Plan            
  • Audit Certificate   
  • Close-Out Discussion

 
  • Color-Coded and Graded Compliance Findings Report
  • Recommendations for Improvement and Achieving Compliance
  • Overall Assessment Consistent with the FDA Definitions of No Action Indicated (NAI), Voluntary Action Indicated (VAI) and Official Action Indicated (OAI)



For more information or to request an Audit, please contact us.
 
HOME | ABOUT NAI | PROFESSIONAL SERVICES | PRODUCTS | ASK THE EXPERT | CONTACT US
(c) 2010 Norton Audits, Inc. All Rights Reserved.