Joseph W. Krotec

Board Certified Obstetrician/Gynecologist with 27 years of clinical practice and a strong background in medical research, serving as an investigator and consultant for various pharmaceutical and biotech companies. Transitioning from active practice, a successful tenure as Medical Director for multiple CROs and clinical development firms spans over 17 years, marked by leadership in numerous pharmaceutical and device studies. A prolific contributor to the field with dozens of publications and presentations at national and international meetings on obstetric and gynecologic topics. Expertise includes directing research initiatives and engaging with the FDA to support product registration. This extensive experience underscores a commitment to advancing women's health through innovative research and clinical excellence.

Part of team to develop new medical surgical device approved by the FDA and taught surgeons best practices.

As Medical Director with Pharmaceutical and device companies and CRO's successfully brought products from Phase 1 through FDA approval

As Line Manager for a CRO lead a team of twelve physicians through the process of drug and device development

Life Fellow of the American College of Obstetrics and Gynecology

• Review of clinical documentation at startup (protocol, case report forms, informed consent, completeness etc.), formulate SOP’s, FAQ’s and other documents
• Communication with investigators and site personnel to answer any queries about eligibility of potential subjects, the protocol or other study related problems
• Project specific medical training (internal and external)
• Medical review of all patient safety and lab data including review and code serious adverse event reports, signaling and PSUR’s, direct supervision of safety department with review and/or development of reports, regulatory agency meetings and filing reports to Health Authorities
• Review of Charts and Listings and develop and/or review CSR
• Meeting with FDA
• Supporting business development

• Women’s Health (OB/Gyn)
• Infertility
• Infectious Disease
• CKD
• Chronic Pain
• Glioblastoma Multiforme
• Long term sedation in ICU
• Hospital acquired pneumonia
• Acute bacterial skin and skin structure infections
• Ulcerative Colitis
• Rheumatoid Arthritis
• Osteoarthritis
• Cardiac – Hypertension, Acute Myocardial Infarction, etc.

• Endometriosis for Dummies, J. W. Krotec, MD and Sharon Perkins, RN, Wiley Publishing, NY, November, 2006
• Check, JH, Krotec, JK, “The Patient with Fibroids” in IVF in the Medically Complicated Patient, a Guide to Management, NS Macklin, United Kingdom, Taylor and Francis, 2005, pp. 139-157.
• “Safety And Efficacy of The HTA for the Management of Excessive Menstrual Bleeding” The Annual meeting of the American Association of Gynecologic Laporoscopists, San Francisco, Ca., November, 2001
• “Comparison of Pregnancy Rates of Oocyte Donors vs. Recipients in a Shared Oocyte Program”, presented at the 1st International Egg Donation Conference, London, UK, February 8, 2005
• Ferring – Phase III Clinical trial; Efficacy of “Endometrim” vaginal progesterone tablets vs. Crinone for luteal phase support in IVF; Co-investigator, 2005
• “The Future of Contraception” The Keynote speech at the Annual meeting of The American College of Obstetrics and Gynecology, New Orleans, Louisiana, May, 1985

Award for outstanding accomplishments in teaching medical students, residents and fellow physicians in the field of Gynecology and Gynecologic surgery.