National Institutes Of Health Tender

The Purpose Of This Contract Is To Provide Support To Niaid Oprm For The Pharmacy And Pharmaceutical Oversight Responsibilities Of National And International Niaid/dait Supported Clinical Trials As Well As Other Nih Funded Clinical Trials On An As-needed Basis, To Ensure Study Product Integrity, Participant Safety, Pharmacy And Pharmaceutical Regulatory Compliance. This Contract Provides Niaid With Centralized Services For: 1) Study Product (i.e., Ip Management, Procurement, Receipt, Storage, Labeling, Packaging/repackaging, Blinding (i.e., Over-encapsulation); Placebo Manufacturing, Sterile Product Manufacturing And Preparation, Blister Packaging, Distribution To Site, Inventory Management, Accountability, Disposal, And Expiration Dates And Recall Monitoring); 2) Ip Regulatory Document Maintenance In The Drmc (regulatory Documents Relating To Shipment, Receipt, Disposition, Return, Destruction, Manufacturing (placebo, Food Product Immunotherapy, Etc.), Over-encapsulation (for Blinding Purposes), Stability/sterility Protocols And Testing, And Labeling And Packaging; 3) Co-submissions Of Drug Master Files (dmfs) And Co-conducting Product Stability Studies; And 4) Clinical Samples Repository, Product Sterility/stability And Release Testing, Clinical Laboratory Testing Such As Immunoassays, Molecular Diagnostics, Dna Sequencing, Flow Cytometry, Etc.