Clinical Development Oversight
Navigating Every Phase from First-in-Human to Approval
Overview
Clinical development is where science meets strategy. From Phase 1 dose-escalation designs to pivotal Phase 3 trials, every decision impacts your path to approval. Our team provides strategic oversight across all clinical phases, ensuring your trials are designed to generate the data FDA needs while remaining feasible and efficient. We work alongside your clinical operations team to anticipate regulatory requirements, prepare for agency interactions, and keep your program on track.
Key Features
Our Process
Development Strategy
We define your overall clinical development plan, including phase timelines, endpoints, and regulatory milestones.
Protocol Optimization
We review and refine protocols to ensure they meet regulatory standards while remaining operationally feasible.
Ongoing Oversight
We provide continuous strategic support, helping you interpret data and adjust plans as your program evolves.
Regulatory Preparation
We prepare you for FDA meetings and ensure your clinical data package supports your marketing application.
Frequently Asked Questions
Why Choose Us
- Trials designed to support your target label claims
- Reduced risk of protocol amendments and delays
- Strategic endpoint selection aligned with FDA expectations
- Proactive preparation for End-of-Phase meetings
- Integrated regulatory and clinical perspective
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Schedule ConsultationWhat Our Clients Say
"Adelphi helped us redesign our Phase 3 protocol after FDA feedback. Their expertise in endpoint selection and adaptive designs resulted in a trial that was both more efficient and more likely to succeed. We achieved approval on our first submission."
Dr. Michael Torres
CMO
Specialty Pharma
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