This guide outlines the components you should consider for designing Phase 2 protocols with marketing approval in mind. Phase 2 is a critical make-or-break stage of product development. All too often, companies inadequately prepare their regulatory strategies and protocols for these proof-of-concept studies causing potentially successful products to be declared ineffective or unsafe.
At Rho, we start with the end in mind. Download our guide to see how we apply our protocol and clinical development expertise to provide meaningful, supportive data to successful marketing applications. This document outlines the following key considerations:
- Objectives, Clinical Endpoints, and Proof of Concept
- Dosage Determination
- Inclusion/Exclusion Criteria
- Statistical Analysis Plan