Adaptive design for a global Study for a First-in-Class Therapy for Critical Covid-19 Patient
Navitas Life Sciences provided end-to-end support to a US Based mid-size biotech company in the development of their first in class therapy for critically ill covid patients. The Phase I study had been conducted in the US, and the company needed a partner to conduct the Phase II study in multiple countries - USA, India and other potential countries.
Navitas Life Sciences’ experienced Medical writers, Medical Leads and Biostatistics teams collaborated to deliver a well designed innovative and adaptive, two stage study protocol within a short span.
Download this Case Study to Learn how we:
- Developed a robust study protocol
- Completed the study in a short span
- Received Appreciation from the USFDA
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