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Norton Audits Government Research Opportunities
08.10.2015
To Leverage our Recent Government Experience
(More)
Norton Audits Capabilities Statement
04.17.2015
In support of U.S. Government requests, 2015 Cap Statement released
(More)

Clinical Investigator Services


Also known as Principal Investigators or PI's, Medical Doctors conducting Clinical Research Trials are the final proving ground for pharmaceutical, medical device and biotechnology product safety and efficacy.  They are chartered with the great responsibility of ensuring patient safety while executing the particulars of scientific protocols and research instructions. 

Through our years of experience with Investigators, Sponsors, CROs, IRBs and the FDA itself, Norton Audits, Inc. is well positioned to assist the existing Clinical Investigator or the Medical Doctor considering entering the Clinical Research Industry.  Our compliance, patient safety and product efficacy focus will assist you in achieving your research goals.

Leverage our Experience and Relationships with Existing Sponsors, CROs, IRBs, other Investigators and the FDA.

 

Investigator Wins 1st Study 2 Months after Mentoring Session

After completing a two-day intensive Mentoring Session in Clinical Investigator Operations, GCP Fundamentals and Site Marketing, and implementing several Norton Audits Standard Operating Procedures , Dr. Earle and his Study Coordinator won their first Study with a major US Pharmaceutical Company.  "The only thing that got us looked at twice, was your seminar" stated Lynda, Nurse Practitioner and Study Coordinator.

 

Minimize Your Research, Organizational and Financial Risks.

Our Investigator Services Include the following and are complimented by our open Consulting Services:

  • Infrastructure  Start-Up Services and Products
    • Introduction to the Clinical Research Industry
    • Good Clinical Practices, Laws and Regulation Training
    • One-on-One Mentoring on Clinical Investigator Operations
    • Standard Operating Procedures (SOPs), Forms and Documents
    • CV Preparation and Marketing Activities to Advertise your Site
  • Continuous Improvement  -  On-Going Services and Products
    • Selecting an IRB
    • Subject Recruitment
    • Study Budget Preparation
    • Obtaining Clinical Research Trials
    • On-Going Training
    • Corrective and Preventative Actions (CAPA ) Programs
  • Individual Needs - Special Services
    • Mock FDA Inspections and Audits
    • Advise on Issues with CROs, Sponsors, IRBs and the FDA
    • Preparing for or Responding to FDA and Sponsor Inspections
    • Investigator-Initiated Research

Ask about our Packages of Combined Services that will maximize your return on our Expertise.

 

Our Therapeutic Experience is Extensive and includes the following :

  • HIV
  • Dental
  • Biologics
  • Diabetes
  • Vascular
  • Geriatric
  • Analgesics
  • Gynecology   
  • Neurodiagostic
  • Ophthalmology
  • Electrophysiology
  • Infectious Disease
  • Medical Devices
  • Antihistamine/Allergy
  • Central Nervous System
  • General Anxiety Disorder 
  • Oncology
  • Transplants
  • Incontinence
  • Osteoporosis
  • Osteoarthritis
  • Gene Therapy
  • Cardiovascular
  • Medical Device  

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


 
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