Quality Assurance Program
Precise project and staff management- GCP Training, HIPAA compliance training, OSHA compliance, internal audits, established and effective SOPs (Volunteer Informed Consent, drug accountability, Adverse Event reporting, drug storage, Serious Adverse Event (SAE) reporting, and site responsibility log for all involved in each trial.) In addition, the research staff is qualified to perform numerous ratings and assessments including, but not limited to, the Structured Clinical Interview for DSM-IV (Axis I and II), Mini International Neuropsychiatric Interview, Hamilton Depression Scale, Montgomery Asborg Depression Rating Scale, Hamilton Rating Scale for Anxiety, and Clinician’s Interview Based Impression of Severity.
Rapid Study Start-Up & Rapid Enrollment Ability
Our Sites are staffed with clinicians and research professionals at the top of their field, with decades of experience conducting clinical research. This involves all areas from screening and randomizing appropriate subjects to the timely submission of IRB materials. The staff continually conducts themselves in a manner consistent with their goal of maintaining a high standard of performance and professionalism. Rapid enrollment is possible because of the site’s extensive patient database. The staff can also quickly develop effective recruitment campaigns focusing on individual study needs.
Culturally diverse patient population with an extensive patient database.
Experience working with many central IRBs, such as Quorum, Schulman, Copernicus, and others.
Ample space for monitoring visits with access to internet, fax, and phone.