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Clinical Research experience

Eastern Carolina Women's Center, PA is rapidly building an excellent reputation for conducting clinical trials in a timely and professional manner.  Since May of 2002, we have completed more than 40 trials, and are enrolling subjects for several more at this time.


The following women’s health indications have been studied in our office:
• Cervical Cancer vaccination
• Premenstrual Dysphoric Disorder
• Contraception/Pregnancy Prevention
• Vaginitis
• Sexually Transmitted Diseases such as genital warts, HPV, and Bacterial Vaginosis
• Endometriosis
• Osteoporosis
• Hormone Replacement
• Clinical Devices
• Sexual Dysfunction
• Overactive Bladder
• Anemia
• Dysfunctional Uterine Bleeding
• Secondary Amenorrhea
• Vaginal Atrophy
• Preeclampsia
• Ovarian Tumors
• Bleeding patterns


We have worked with many pharmaceutical companies as sponsors of clinical trials.  They include Novartis, Pharmacia, Pfizer, KV Pharmaceuticals, Warner Chilcott, Solvay, Glaxosmithkline, Berlex, Luitpold, Eli Lilly, Wyeth, Duramed/TEVA, Roche, Hormos, Boehringer Ingelheim, Ciphergen, Ortho-Clinical, Third Wave, Bayer, Noven, Amgen and Takeda/3M.


Clinical Trial Staff


Jeffrey A. Michelson, MD, FACOG, CPI


Jeffrey A. Michelson, MD, FACOG, CPI, our Principle Investigator with 14 years of experience in clinical trials is a member of the Association of Clinical Research Professionals (ACRP), is board certified in his specialty, and a Certified Physician Investigator through ACRP.  As a physician in this practice, not only does he oversee the care of his patients but he also reviews the charts of all other clinical trial participants.


Kelly Nichols, LPN, CCRC


Kelly Nichols, LPN, CCRC has 9 years experience in clinical trials and is also certified by ACRP as a Certified Clinical Research Coordinator.  She obtained her nursing license from the North Carolina Board of Nursing in 1998.  As the director of the clinical trials department, she works closely with Dr. Michelson to ensure patient safety, discover new trials and coordinate other trials.  
 

Information

Demographic Data

  • SITE INFORMATION 
  • Start year clinical research2002
  • Phases of clinical studiesPhase II, Phase III, Phase IV
  • Types of studiesBiologics, Drugs, Medical Devices, Vaccines
  • PopulationsAdult 18-64 yrs
  • SPECIFIC SITE INFORMATION 
  • Type of sitePart of a practice
  • # of employees involved in research3
  • # of investigators10
  • Days openMonday, Tuesday, Wednesday, Thursday, Friday
  • Extended office hoursYes
  • Dry iceYes
  • Blinded pharmacistYes
  • Dedicated monitoring spaceYes
  • Internet access for the monitorYes
  • Onsite laboratoryYes
  • Central laboratoryYes
  • Infusion capabilityYes
  • Shipping optionsFedEx, UPS
  • REGULATORY INFORMATION 
  • Contact for regulatory documentsKelly Nichols
  • Regulatory phone number252-633-3942
  • # of days to turn around regulatory documents7
  • Type of IRB used by this siteCentral
  • Appropriate storage facilities for productYes
  • Able to appropriately store Schedule II drugsYes
  • FINANCIAL INFORMATION 
  • # days to turn around budget and contract7-10

Contacts