Clinical Supplies Consulting

The success of a clinical program depends on proper study design, on-time initiation, and the ability to respond quickly to last minute changes. CSM^®'s team of experienced clinical supplies consultants knows the steps in the critical path of the clinical supply chain. They work with your team to ensure a smooth supply process, even for complex clinical supplies problems.

• Total project management
• Development of packaging and labeling requirements (interpreted from study protocol)
• Packaging design development
• Oversight of packaging and labeling operations
• Global studies management (including QP release)
• Label text generation, translation, and approval
• Batch record review and approval
• Comparator drugs and ancillary supplies — identification and sourcing