NSI is proud of its impeccable research practices, as demonstrated by the successful outcomes of four FDA audits conducted from 2007 to 2010 with no findings. Keith Saylor, PhD, has been the Principal Investigator for clinical trials for psychiatric medications since 1988. He works in conjunction with two physicians, including a Board-Certified Psychiatrist. Other personnel include a doctoral-level rater, a research director, two experienced study coordinators, and administrative staff. There is very little turnover, with key staff having been in place from 8 to 15 years. Study Coordinators have experience with numerous Electronic Data Capture and IVR systems.
All staff have undergone formal ethics training and are well versed in Good Clinical Practice.
NSI has a dedicated, secure, climate-controlled drug storage room that has been inspected and approved by the Drug Enforcement Administration. Compounds are stored in locked cabinets that are built into the wall. Security measures include steel grids under the ceiling panels, motion sensors, and a security alarm. Access is strictly limited. Temperatures in storage cabinets are recorded daily with min/max thermometers.
Standard Operating Procedures are in place for the consent process, laboratory procedures, drug accountability, confidentiality, and other areas. Equipment in the site’s two laboratories includes centrifuges, ECG machines, a stadiometer, weight scales, a -20 freezer, a lab refrigerator, and blood pressure machines, all professionally calibrated twice a year.
NSI maintains comfortable clinical offices for assessments and other study procedures, as well as a conference room and other offices for monitors and guests.
The site is able to use central IRBs and other central vendors for studies.
