Norton Audits, Inc. <> Norton Audits Clinical Research and Trials Consulting Services

Overview

Auditing

Consulting

Publications

Clinical Investigator Services

Training Overview and Options

Audio Conferences

On-Line Training

Mentoring Training

Public Training Classes

On Site Training

3rd Annual Auditing Forum Scheduled

01.01.2010
March 2010 Expert Techniques, Panel Discussions and Case Studies Presented (More)

Clinical Investigator Mentoring Customer Earns First Studies

11.21.2009
Three Sponsors Issue Studies Since NAI SOPs and Consulting Implemented (More)

Whether you are a Clinical Investigator, Sponsor, CRO, IRB or other Clinical Research Organization, our independent expertise combined with direct experience in regulatory agencies and hundreds of organizations like yours allow us to provide project-based and advisement services to assist you in achieving your goals.

Our Consulting Experience and Offering Includes, but is not limited to:

Mock FDA Inspections
Site Qualifications
Organization Risk Assessments
Study Budget Preparation
Protocol and Associated Forms Development
Policy and Standard Operating Procedure (SOP) Development
Assisting Clinical Investigators in the process of Obtaining Clinical Trials
Preparing for or Responding to FDA and Sponsor Inspections and Audits
FDA Submission Preparation, Including:
- Investigational New Drug Application (IND)
- New Drug Application (NDA)
- Pre-Market Application (PMA)
- Medical Device 510(k)
- Post-Market Surveillance Activities

For more information or to request our Services, please contact us.


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