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.
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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
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- Neurodiagostic
- Ophthalmology
- Electrophysiology
- Infectious Disease
- Medical Devices
- Antihistamine/Allergy
- Central Nervous System
- General Anxiety Disorder
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- Oncology
- Transplants
- Incontinence
- Osteoporosis
- Osteoarthritis
- Gene Therapy
- Cardiovascular
- Medical Device
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For more information or to request our Services,
please contact
us.
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