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. After 10 years at Duke Univeristy, Dr. Lukes brings together an experienced research team. Led by Atiya Sherwani, CCRA, we have completed over 20 FDA clinical trials within our first few years.
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