Research

Our group is actively involved in different research opportunities. The Carolina Women's Research and Wellness Center was established in 2006 by Dr. Andrea Lukes. The focus is clinical research for women of all backgrounds and all ages; however, more recently we have conducted research in primary care (for women and men). After 10 years at Duke Univeristy, Dr. Lukes brings together an experienced research team. We have completed over 50 FDA clinical trials.

In the summer of 2009, we were inspected by the FDA because of high enrollment in clinical trials relating to the drug Lysteda. The FDA found our team and site to have a process in place that was 100% compliant with FDA and GCP regulations (no 483 issued).

Services relating to our research include the following:

  Ability to use Local and Central IRBs

  Study coordinators trained for GCP/FDA CFR

  Laboratory and Venipuncture Services

  Centrifuge

  Dry Ice Availability

  ECG

  Electronic Data Capture (EDC) Experience

  IVRS Experience

  Detailed Pelvic Ultrasounds

 

NOW enrolling for the following new studies:


Heavy Periods/Uterine Fibroids

•Chronic Migraines

•Mirena IUD Extension Study (qualify if you have had IUD for 4.5 years)

•Endometriosis

•High Risk HPV with Cervical Dysplasia

•Dense Breast on Mammogram

 

For more information, please call the clinic @ 919-251-9223

 

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