Grossmont Center for Clinical Research (GCCR) is rapidly building an excellent reputation for meeting or exceeding recruitment goals, and conducting women's health care trials in a timely and professional manner. Since August 2008, GCCR has completed 5 trials and was ranked as a high enroller for 4 of the completed trials. At this time, our site is successfully recruiting and conducting 7 trials, and expects to begin enrolling for 3-4 new studies in the near future. Our research is specialized to women's health care and Phase II-IV trials.

Therapeutic areas include:

• Menopausal symptoms/HRT
• Overactive bladder and urinary incontinence
• Contraception
• Anemia
• Dysmenorrhea
• Endometriosis
• Fibroids
• Osteoporosis
• Pre-term Delivery
• Sexual Dysfunction
• Vaginal Atrophy
• Cervical abnormalities and cancer vaccination
• Genital Warts, HPV
• Bacterial Vaginosis
• Genital Herpes, HSV

GCCR has worked with the following:

Sponsors: Advaxis, Allergan, Astellas, Barr Laboratories, Boehringer Ingelheim, Depomed, Duramed, Hologic, KV Pharmaceutical, NanoBio Corporation, Noven Therapeutics, Pfizer, and Sequenom, Inc.

CROs: Covance, INC Research, Kendle, K-Force, PPD Development, PRA International, Quintiles, and TEVA

The Principal Investigator devotes 90% of his time to conducting clinical research trials, and is always available either on-site or after hours.

Principal Investigator:

• Gioi N. Smith-Nguyen, M.D., F.A.C.O.G.
  Board Certified - Obstetrics and Gynecology
  In practice since 1985 with 3 years research experience as PI and Sub-I

Sub-Investigators:

• Mearl A. Naponic, M.D., F.A.C.O.G.
  Board Certified - Obstetrics and Gynecology
  In practice since 1974 with 1.5 years of research experience
• John S. Missanelli, D.O., F.A.C.O.G.
  Board Certified - Obstetrics and Gynecology
  In practice since 1980 with 1.5 years of research experience
• C. Hamilton Steele, M.D.
  Obstetrics and Gynecology
  In practice since 1980 with 1.5 years of research experience
• Larry M. Cousins, M.D.
  Board Certified - Obstetrics and Gynecology
  Board Certified - Maternal-Fetal Medicine
  In practice since 1980 with 32 years of research experience
• Sean S. Daneshmand, M.D.
  Board Certified - Obstetrics and Gynecology
  Board Certified - Maternal-Fetal Medicine
  In practice since 1999 with 1 year of research experience

GCCR physicians and research staff are committed to conducting clinical research protocols while maintaining the highest standards for clinical research and compliance with GCP, ICH, and HIPAA guidelines, patient safety including appropriate communication and reporting procedures, regulatory compliance, and quality data collected and submitted in a timely manner.

• Peggy Smith-Nguyen, B.A., CRC
  Operations and Regulatory Manager
  2 years research experience
• Charlotte Payton-Ross, B.A., CRC
  Quality Assurance and Coordinator Supervisor
  36 years research experience
• Annie Marie Christensen, CCRC, ACRP
  Certified CRC, Certified Medical, Laboratory Assistant, and Phlebotomist,
  12 years research experience
• D. Noelle Workman, CRC
  Clinical Research Coordinator and Certified Phlebotomist
  3 years research experience
• Tuyet Vo Collucci, B.A., CRC
  Clinical Research Coordinator
  1 year research experience

GCCR patient population includes women of all ages ranging from puberty to post menopausal populations. Ethnicity is approximately 40% for Caucasians, 25% for African American, 25% Hispanic, and 3% Asian, and diverse backgrounds are represented. Approximately 50% of our subjects are recruited from the affiliated OB/GYN Medical Group patient base of 60,000 that is also the exclusive referral center for OB/GYN patients in East County of San Diego, 25% from referrals from other practicing OB/GYN specialists in our medical building, and 25% from advertising and community outreach. GCCR has consistently met or exceeded enrollment goals for diverse protocols, and there are currently no other entities solely devoted to clinical research in East San Diego County.

Obstetrics/Gynecology