Q. Do we have a dedicated area for monitors work when they come?
A. We have a comfortable, spacious area for monitoring that includes WiFi and access to printers, copiers, and fax machines. Our clinical operations are run out of the same building, so it is easy for our investigators to be available for monitoring visits as needed.
Q. What is the nearest airport?
A. Charleston International Airport (CHS) is located 7 miles from our West Ashley office and 17 miles from our Mount Pleasant office.
Q. How are our medical records stored?
A. We use an Electronic Medical Record system called AthenaHealth. This system aids in a wide range of functions such as recruitment, screening, scheduling, and more. CRAs are able to have view access only however AthenaHealth does not provide functionality to group research subjects in one list.
Q. Where is the nearest Hospital and/or Emergency Department?
A. In case of an emergency, we prefer to entrust our kiddos to the MUSC Pediatric Emergency Department because of the specialized pediatric care that they receive there. The MUSC Pediatric ER facility is about 7 miles away from our West Ashley office. However, Bon Secours Saint Francis Hospital is also a wonderful hospital and it is located right across the street, less than half a mile away.
Q. Have we used EDC? IVRS? IWRS? eDiaries?
A. Yes, the site staff has experience with several difference EDC systems, IVRS systems, and ediary systems. To name a few, the site has used Medidata Rave, Inform, MyTrials, TrialMax, OC-RDC, Clinphone, TrialMaster, Perceptive, and ERT.
Q. Does our site have trained and experienced personnel that are able to perform blood draws in infants, toddlers, adolescents, and teens?
A. Yes, we have trained nurses and coordinators who are able to successfully perform blood draws on all age groups. We also have a vein finder at our site.
Q. Does our site have the appropriate equipment to successfully run a clinical trial?
A. Yes, we have calibrated scales for infants through adults, calibrated centrifuge to complete lab processing, calibrated equipment to complete vital signs, a secure and locked area only accessible to study staff for study medication storage, a refrigerator for biological agents, an ECG, a -20 °C freezer for sample storage, a -70 °C freezer for sample storage, continuous temperature monitoring on our IP refrigerator and -70 °C freezer, designated space to accommodate subjects for observation periods.
Q. Does our site use a local or central IRB?
A. We use central IRBs as specified by the sponsor