SMART First Human Dose (FHD)

The SMART FHD team at PCI can provide a development path that will be months faster to first human dose clinical trials and years faster to market than traditional formulation development timelines by managing the following:

• Develop and manufacture min & max drug-incapsule dosages
• Qualify test methods and conduct a bracketed stability protocol including packaging, storage, and testing and provide reports
• Manufacture Drug-in-Capsule dosages, bottle, and label for clinic use
• Compile all CMC information for regulatory submission
• QP release the clinical drug
• Manage inventory and distribute the drug for clinical use
• Supply project management to organize and oversee all aspect of the development project

It can take up to two years to prepare for your first clinical trial in the US. With PCI’s SMART FHD that time can be reduced to be just a few months.

• Rapid Access to Clinical Data
• Drug Development Removed from Critical Path
• Receive “White Glove” Service
• Significant Financial Savings
• Time & expense of multiple development activities eliminated
• Flexibility of Supply through Phase 2a (& possible beyond)