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Research Center Profile:
Grossmont Center for Clinical Research

Center Information

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
USA
619-589-4100
619-589-4104 (fax)
info.gccr@gmail.com
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Therapeutic Areas

Devices
Gastroenterology
Nephrology
Obstetrics/Gynecology (Women’s Health)
Urology

Center Overview

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.

Clinical Research Experience

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:

  • Abnormal Pap Smears
  • Anemia (Iron-Deficiency)
  • Cervical Dysplasia
  • Constipation
  • Contraception
  • Contraceptives (Devices)
  • Contraceptives (Oral)
  • Depressive Disorders
  • Dysfunctional Uterine Bleeding
  • Dysmenorrhea
  • Endometriosis
  • Genital Herpes
  • Genital Warts
  • Gout
  • Herpes Simplex Infections
  • Hormone Replacement Therapy
  • Hot Flashes
  • Human Papilloma Virus
  • Hypoactive Sexual Desire Disorder
  • Irritable Bowel Syndrome
  • Menopause
  • Menopause and Libido
  • Menorrhagia
  • Menstrual Problems
  • Osteoporosis
  • Overactive Bladder
  • Postmenopausal Syndrome
  • Premenstrual Syndrome
  • Sexually Transmitted Diseases
  • Uterine Fibroids
  • Vaginal Atrophy/Vaginitis

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.

Facility Description

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:

  • Reception area for subjects
  • Convenient complimentary parking for participants
  • CLIA certified on-site laboratory
  • Phlebotomy and specimen processing station
  • Centrifuge, microscope, and autoclave
  • IATA certified staff
  • Dry Ice
  • Dedicated and locked -70F and -20F freezers
  • Dedicated and locked refrigerator
  • Dedicated and locked drug storage room with locked cabinets for investigational drug/supplies
  • Temperature logs maintained for freezers, refrigerator, and drug room
  • Emergency Cart in clinical area
  • Secure areas for storage of case report forms and study files
  • Prospective database of potential research subjects from 60,000 patient referral base
  • Collection of lab specimens (biopsies, pap smears, blood draws)
  • Diagnostic bladder ultrasound
  • Electrocardiogram
  • LEEP and colposcopy procedures
  • eSource where appropriate
  • Electronic data capture (EDC)
  • Paperless case report form (eCRF)
  • Remote Data Entry (RDE)
  • Electronic patient diaries and patient reported outcomes
  • Daily FedEx and UPS pick-up
  • Internal Quality Assurance Review Program
  • Secure computer network
  • Uses central IRB and has experience with Aspire, Chesapeake IRB, Copernicus, Magil, New England, Quorum, Schulman, Harrison, Independent, IntegReview, IRBs and WIRB.
  • Prompt turn-around of regulatory documents, contract, and budgets within one week
  • Designated space for CRAs with access to copier, fax machine, and high speed internet

Investigator Experience

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

Sub-Investigators:

  • Mearl A. Naponic, M.D., F.A.C.O.G.
    Board Certified - Obstetrics and Gynecology
    In practice since 1974 with 4 years of research experience
  • C. Hamilton Steele, M.D.
    Obstetrics and Gynecology
    In practice since 1980 with 4 years of research experience
  • William E. Friedel, M.D., F.A.C.S.
    Board Certified – Urology
    In practice since 1980 with 10 years of research experience

Staff Expertise

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.

  • Peggy Smith-Nguyen, B.A., CRC
    Operations and Regulatory Manager
    5 years research experience
  • D. Noelle Workman, CRC
    Clinical Research Coordinator and Certified Phlebotomist
    4 years research experience
  • Tuyet Vo Collucci, B.A., CRC
    Clinical Research Coordinator
    3 years research experience
  • Nicolette Peterson, M.A., CRC
    Clinical Research Coordinator
    3 years research experience

Principal Investigator, Dr. Gioi Smith-Nguyen and Clinical Research Coordinator, Noelle Workman

Patient Demographics

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:

  • Friendly and courteous staff, punctual with care to avoid over-scheduling of patient appointments
  • Good physician bed side manner with priority to earn patient trust and to consider patients general welfare and medical safety above financial gains
  • Priority to allow ample time for patients to read consent forms, to ask questions, and to encourage participation in trials only if patient is comfortable
  • Staff routinely addresses patient concerns, questions, and phone calls are returned promptly
  • Compensation provided for patient time and travel
  • Careful follow-up of patients before, between, and after visits
  • Reminder calls are routine the day before a study visit
  • Patients have access to doctor or staff 24/7 at the office or at the afterhours emergency phone number

Other Information

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

  • 27Jan10:
    "I am writing to ask if you would consider leading one of our information sharing conference call you were suggested because of your knowledge of research, your past success with clinical trials and your vast experience as one of the foremost OB doctors in your area. You have a fantastic personality and strong rapport not only with patients but with your clinical counter parts."
    Clinical Enrollment Manager

  • 09Mar10:
    "That is fantastic! You are our 2nd highest enroller with 9 randomized subjects. The xxx team truly appreciates your hard work on this trial!"
    Clinical Enrollment Manager

  • 09Apr10:
    "I wanted to say thank you for the quick turnaround of CDAs for this exciting trial."
    Regional CRA II

  • 13Apr10:
    "I would like to thank you and your staff for their time and attention during my recent monitoring visit…data has been entered within the established timelines…no protocol deviations identified…no action items pending at the end of the visit."
    Clinical Research Site Manager

  • 02Jul10:
    "Thanks for such a quick response, by the way! You guys are awesome! Maybe my favorite site so far!"
    Clinical Research Associate

  • 06Aug10:
    "Ti did a great job participating in the recruitment teleconference the other day. In addition, your excellent performance in recruitment is noted."
    Clinical Research Associate

  • 27Mar09:
    "Your reasoning is excellent; I agree that the patient should remain on trial."
    Medical Director

  • 04May09:
    "Peggy is so very detailed oriented, organized, and immediately incorporates any suggestions that I never mention twice - truly exceptional!!!

    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

  • 27May09:
    "Presently we are looking at a few trials and I do have you and your site in mind. I realize that you have all of the qualifications and experience needed to be successful and I hope that I can place something with you soon."
    Project Director

  • 26May09:
    "Thank you for your interest in our upcoming trial, at this time we are hoping to have the new protocol finalized by the middle of June and the first sites initiated in July. We will definitely make sure you are one of the first. The patient population will be very similar to the current trials."
    Clinical Project Manager

  • 03Jun09:
    "Thank you for your informative emails. I'm happy to hear of your impressive enrollment numbers!
    We are REALLY looking forward to our upcoming visit. Our last visit was such a pleasant experience for us! You and your team have gone above and beyond to accommodate us, and we are very grateful for that. Not only have you been accommodating, your site has also taken the time and effort to do your best work possible and it shows! See you soon : )"
    Clinical Research Associate

  • 31Jul09:
    "I wanted to contact you regarding the noninvasive screening for xxx study that xxx is conducting. I would like to inform you that the Sponsor is very pleased with your quick response and they really appreciate your enthusiasm. The sponsor would like your site to be the first of fifty activated sites in the study. Your patient population and your positive attitude is exactly the type of physician/site we would like activated first." Because the sponsor is targeting your site to be the first activated, they want to ensure that your site can meet the following:
    • All Regulatory Documents approved and site activated by August 5th
    • Have first patient in by August 10th"

    Site Management Associate

  • 01Aug09:
    "Because you are vital to the investigation of the xxx compound, my instructions are to be of value to you in the contracting process and give you the courtesy and comfort you deserve so you can have a contract you're happy with."
    Contracts Analyst

  • 12Aug09:
    "Your information is very valuable and of great help for our continued bid for this project. Your experience, knowledge, support staff and location are very positive factors."
    Business Affairs Associate

  • 14Aug09:
    "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."
    Sr. Clinical Research Associate

  • 14Aug09:
    "I appreciate your dedication and hard work in trying to get your site up and running."
    Site Management Associate

  • 18Aug09:
    "We appreciate your hard work and we look forward to working with your site!"
    Clinical Research Associate

  • 18Aug09:
    "We have decided that you may use your original DXA facility- Diabetes and Endocrine Associates. We appreciate your eagerness to participate in this study and all the hard work and dedication you have already put into this study."
    Clinical Project Assistant

  • 27Aug09:
    "I am always happy and thrilled to work with a site that exudes excitement and strives for excellence.

    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

  • 02Oct09:
    "Again, thank you for your work on subject recruitment for the xxx study and also your over all focus on providing quality research data. I would also like to in turn thank you for your hard work with subject recruitment for this trial and to thank both Charlotte and Noelle for working hard at correcting the issues that arose during my interim monitoring visit.

    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

  • 17Nov09:
    "Great news!!! I just found out that your site is among the top-enrolling sites for the study. There is another site that has screened 12 and randomized 8 and then your site that has screened 11 and randomized 6. Great job everyone!! Keep up the excellent work. I look forward to even more subjects."
    Clinical Research Site Manager

  • 01Dec09:
    "Thank you so much for this letter, it is absolutely perfect! We very much appreciate your kind words. And please know that whenever new studies come our way I will always consider your site for them.…And we very much enjoyed working with you!!"
    Project Manager

  • 12Dec09:
    "By the way, you are the enrollment star for the xxx study!!"
    Therapeutic Area Manager

Contact Center

If you are interested in contacting this center to discuss placing a clinical trial there, please complete and send the email form below. A representative from the research center will then follow up with you.

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