Well established pharma company required both a TQT and Multiple-Ascending Dose (MAD) protocol for a narcotic compound to advance their NDA commitments
Drug has potential safety concerns and establishing the upper safe dose and dosing interval is complicated by ensuring subject safety
Approach
Quickly enlisted a team of internal experts (cardiologist, cardiac central labs personnel, statistician, pharmacokineticist, director of cardiac safety services, protocol development team) to determine the appropriate recommendations for these two complex studies
Recommendations collected by the protocol development team sent to the client within 2 days
Detailed discussions immediately ensued as a result of the initial input enabling client to meet the FDA requested timelines
Involvement of the team continued throughout the protocol development process enabling both protocols to be finalized within 3 weeks
Benefits
The client was able to provide the FDA with the protocols for review and obtain approval to proceed with their Phase I program thus advancing their timelines for approval
Comprehensive input from multi-disciplinary team facilitated quality protocol development
Expeditious timelines for protocol development enabled a faster turnaround for regulatory approval of the protocol and thus trial initiation
