Institutional Review Board (IRB)

Institutional Review Board (IRB) is a committee of healthcare professionals dedicated to overseeing sponsors and investigators on their safe, compliant research.

Institutional Review Board

Institutional Review Board (IRB) is a committee of healthcare professionals dedicated to overseeing sponsors and investigators on their safe, compliant research.

Preventive Medicine Research Group is an approved and registered Institutional Review Board (IRB). Patient safety is our number one priority, therefore our committee consists of patient advocates and some of the leading experts in medicine to ensure safe, compliant, and ethical research.

Our mission is to provide oversight and advancement of research that is ethical and ensures patient safety, while promoting the effectiveness of clinical protocols in the scope of preventive medicine. We are continuously looking for principal investigators to submit IRB’s and we will help you every step of the way to ensure safe and compliant research.

Preventive Medicine Research Group complies with all federal regulations pertaining to the protection of human research subjects. Preventive Medicine Group has a Federal Wide Assurance (FWA) and is registered with the Office for Human Research Protections.

FWA: 00029564 IORG: 0010577
IRB Registration: 00012539

How to Apply

1. Complete IRB Applicant Contact Form (Our IRB committee reviews the title of your study to vet potential applicants).

2. Complete IRB Application and Attach Corresponding Documents: (All application material is due the last Wednesday of every month)

3. Payment due at time of application

4. IRB Interview (Board meets 1st Wednesday of each month)

5. IRB Approval or Rejection

Provider Sponsored Investigational New Drug (IND) Consultation

During a new drug’s early preclinical development, the sponsor’s primary goal is to determine if the product is reasonably safe for initial use in humans, and if the compound exhibits pharmacological activity that justifies commercial development. We provide guidance on the process, including setting up pre-IND meetings, creating the investigator’s brochure, and helping with Chemistry Manufacturing and Control (CMC) information. 

For a complete description of consultation services, click the button below. 

If you’re interested in IND Consultation, complete the form below. 

Provider Sponsored Investigational New Drug (IND) Consultation

  1. Preventive Medicine.org offers consultation for provider-sponsored INDs. Consultation includes:
  2. Names and titles of those who might or would participate in a meeting
  3. Chemistry Manufacturing and Controls (CMC)
    • Certificates of Analysis from the manufacturer of the Active Pharmaceutical Ingredient (API) and the inactive ingredients
    • Any test data we have generated on the API and inactive ingredients
    • Any test data on the finished product
    • Dissolution data
    • Stability Data
  4. Non-clinical Literature Summary: A short summary of non-clinical studies in animals on the product
  5. Clinical Literature Summary: A short summary of clinical studies in humans, if any, on the product
  6. Clinical Rationale for use of the product in this patient population
  7. Clinical Study Protocol synopsis
    • Objectives
    • Drug product and dose
    • Pharmacokinetics (PK), if any
    • Inclusion and exclusion criteria
    • Clinical Outcome measures (safety and efficacy)
    • Follow up
    • Statistical analysis plan


Consulting Fee(s) and Registration information to be announced soon. 

 

Mickey Karram, MD

Dr. Karram is an internationally renowned urogynecologist and pelvic surgeon. He is board certified in Obstetrics and Gynecology as well as Female Pelvic Medicine and Reconstructive Surgery.  He completed his fellowship training in Urogynecology at Harbor UCLA School of Medicine. He is the Honorary Editor-In-Chief of the International Urogynecology Journal and the consumer publication Female Health Today, as well as the  past president of the American Urogynecology Society.

He has published more than 200 scientific articles and book chapters and has co-authored numerous textbooks including, “Urogynecology and Reconstructive Pelvic Surgery,”  the “Atlas of Pelvic Anatomy and Gynecologic Surgery” along with a series of eight books entitled “Female Pelvic Surgery Video Atlas.”

Dr Karram has directed numerous  post-graduate teaching courses throughout the United States and abroad. He has been invited to lecture and perform demonstration surgeries throughout the United States, Europe, Asia, South America and Australia. Dr Karram has been designated by Good Housekeeping magazine as one of the “Best Doctors in America for Women.” He and his wife Mona co-founded the national, not-for-profit, Foundation for Female Health Awareness, which raises funds to support education and research for women’s health.

Become a Founding Member Today!

Membership is Free through 12/31/2021

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