When a sponsor needed to bring a dual orexin receptor antagonist (DORA) to market for insomnia, they turned to Clinilabs for comprehensive CNS trial support. From first-in-human through global Phase 3 trials, Clinilabs delivered seamless operational, regulatory, and scientific support that culminated in successful NDA submission and approval.
Download the case study to learn how Clinilabs helped accelerate this sleep disorder drug development program by:
- Designing and executing an adaptive Phase 1 trial that progressed from healthy volunteers to insomnia patients
- Providing expert support across Phase 2 proof-of-concept and global Phase 3 safety and efficacy studies
- Engaging full-service capabilities, including PSG Corelab, project management, data handling, and pharmacovigilance
- Building a cohesive, lockstep client-CRO partnership from early phase to post-market support in Asia
Ready to see how integrated expertise can take your product all the way?
