TUBERCULOSIS (TB) CLINICAL DRUG MANAGEMENT SUPPORT

The scope of drug management activities may range from small single site studies to large Phase 2 and long-term Phase 3 clinical trials to evaluate new TB drugs and drug regimens and preventive interventions. These services shall ensure provision of quality assured TB medications for use in clinical trials compliant with U.S. and international standards of good clinical practice and study product accountability.

As these trials are conducted under IND, they have the potential to be audited by US Food & Drug Administration and/or other regulatory agencies, therefore drug management services shall adhere to established practices for clinical trial medication supply. • Project management of the drug management pathway for multiple clinical trials • Purchase of quality-assured tuberculosis (TB) drugs for clinical trial use • Receipt, Storage, and Labeling of Investigational Products • Temperature controlled and monitored shipping of TB drugs to TBTC trial sites; and • Tracking of contract activities with performance reports and remediation of any deficiencies