When evaluating an investigational product with potential CNS and cardiovascular risks, launching a first-in-human (FIH) trial comes with heightened safety concerns and strict protocol requirements.
In this case study, see how Clinilabs navigated a complex Phase 1 design while safeguarding subjects and meeting the sponsor’s original timeline by:
- Reworking the dosing schedule to reduce subject risk while preserving timelines
- Managing intensive EEG and ECG safety protocols, including photic stimulation and hyperventilation
- Implementing real-time orthostatic vital signs monitoring to flag syncope events
- Delivering quality data with zero major protocol deviations and minimal queries
