Gioi N. Smith-Nguyen, M.D., FACOG
Director and Principal Investigator
Grossmont Center for Clinical Research
8851 Center Drive, Suite 206
La Mesa, CA 91942
Grossmont Center for Clinical Research (GCCR) is a dedicated research facility specializing in women’s health care, and is located in La Mesa, CA, in East San Diego County. GCCR is the only research clinic in East San Diego County and would offer a population of subjects that are demographically separated from and would not be in competition with San Diego sites for recruitment of study subjects. GCCR was established by the Grossmont OB/GYN Medical Group, Inc., to provide research opportunities for the 60,000 patient base of 4 OB/GYN specialists in practice for over 40 years. In addition to referrals from the OB/GYN private practice, there are five other practicing OB/GYN and two urology specialists in the same medical building that is located within 300 yards of Grossmont Women’s Center and Sharp Grossmont Hospital that is a level 3 facility. Using good clinical practice guidelines, the research staff of GCCR is driven to complete studies in a timely, ethical, and efficient manner, and to meet recruitment goals and timelines from physician referrals and a practice and research subject database. There are currently no other entities that are solely devoted to clinical research in East San Diego County, and is an excellent site for women’s health pharmaceutical and device clinical trials.
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 25 trials and was ranked as a high enroller for 15 of the completed trials. At this time, our site is successfully recruiting and conducting 9 trials, and expects to begin enrolling for 2-3 new studies in the near future. Our research is specialized to women’s health care and Phase II-IV trials.
Therapeutic areas include:
GCCR has worked with the following:
Sponsors: Advaxis, Agile, Allergan, Barr Laboratories, Bayer, B.D., Boehringer Ingelheim, Depomed, Duramed, Hologic , KV Pharmaceutical, Luitpold, Merck, Noven Therapeutics, Pfizer, Sequenom, TEVA, Watson Pharmaceuticals, Medicis, Furiex, Trimel, and Abbott.
CROs: Covance, Imed, INC Research, Kendle, K-Force, PPD Development, PRA International, OSP Clinical Research, Renaissance Associates, Medpace, and Neurocrine.
Grossmont Center for Clinical Research (GCCR) is a dedicated, outpatient research center that is easily accessible to public transportation, freeways, and the San Diego International Airport. GCCR is located in a medical complex that includes Grossmont Women’s Center and Sharp Grossmont Hospital, a level lll, 400+ bed hospital in La Mesa, CA, in East San Diego County.
Our site capabilities and features:
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, Dr. Gioi Smith-Nguyen, MD, FACOG
Board Certified - Obstetrics and Gynecology
In practice since 1985 with 5 years research experience as PI and Sub-I
GCCR's team of doctors and staff
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.
Principal Investigator, Dr. Gioi Smith-Nguyen and Clinical Research Coordinator, Noelle Workman
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 our 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 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.
Additional GCCR procedures to promote compliance:
Sponsor and CRO comments about Grossmont Center for Clinical Research:
"If I am not lucky enough to be assigned to this study and to your site, I know that you will produce great work! I hope we have an opportunity to work together if not on this study, sometime in the future."
2012, Senior Clinical Research Associate
"Peggy is so very detail oriented, organized and immediately incorporates any suggestions that I never mention twice – truly exceptional! I am still proud of your outstanding recruitment as you complete the study visits and care for the subjects. It’s a delight to work with you and Peggy and I sincerely hope to have the opportunity again in the future!
Your dedication to hard work and excellence is certainly appreciated and I’m so proud of the quality clinical research that you have developed. I hope to be your CRA again in the future! Peggy is so careful and detail-oriented and such an asset and delightful, intelligent colleague and friend!"
2011, Clinical Research Associate
"Again, thank you for your work on subject recruitment for the recent study and also your overall focus on providing quality research data. I would like in turn to thank you for your hard work with subject recruitment for this trial and to thank Charlotte and Noelle for working hard at correcting the issues that arose during my interim monitoring visit."
2010, Clinical Research Associate
"It is with great pleasure that I complete this recommendation for Dr. Gioi Smith-Nguyen. His work on 2 of our studies as a principal investigator was outstanding. This site was quick to turn around essential document packets and very timely with the contract negotiation process.
Once the site was initiated, they were very quick to begin the pre-screening process and enlisted more than was required for these challenging, Phase 3 hot flash studies.
Data entry into our EDC or Remote Data Capture system was timely as and the site was consistent in timely completion of data entry and query response.
Dr. Smith-Nguyen also emailed me as the project manager periodically to check on his site’s performance and the studies progress.
His dedication to the research field and conscious effort to ensure his contributions for eligible subjects was met and that his site’s quality of data was intact is to be commended. I applaud such outstanding performance from an investigator and their staff."
Previously: Sr. Project Manager, PPD
I am still proud of your outstanding recruitment success and your careful follow-up and documentation is just as outstanding as you complete the study visits and care for the subjects. It's a delight to work with you and Peggy, and I sincerely hope to have the opportunity again in the future!!! I am confident that your conscientious hard work will bring your research clinic many studies in the future!!!
Your dedication to hard work and excellence is certainly appreciated, and I'm so proud of the quality clinical research clinic that you have developed - I
hope to be your CRA again in the future! Peggy is so careful and detail-
oriented, and such an asset and delightful, intelligent colleague and friend!"
Clinical Research Associate
Also, congratulations on enrolling your first patient into the study. I commend you and your staff for enrolling a patient without receiving any supplies necessary to perform the procedure. I mailed to your attention a Reg Binder, MBS kits, and all other essential supplies for the study. This should make enrolling patients in the future a little easier for you and your team."
Site Management Associate
Since, your site is a high enrolling site, it is especially helpful that you have Charlotte on board as a quality assurance member of your team."
Clinical Research Associate