Preclinical Strategy & IND-Enabling Studies
Building the Scientific Foundation for Clinical Success
Overview
A robust preclinical program is essential for de-risking your clinical development and securing FDA authorization to begin human trials. Our team brings decades of experience in preclinical study design, GLP toxicology requirements, and pharmacology packages that satisfy FDA expectations. We work closely with your scientific team and CRO partners to ensure every study generates the data you need for a successful IND submission, while optimizing timelines and budgets.
Key Features
Our Process
Program Assessment
We review your molecule, mechanism of action, and existing data to identify the optimal preclinical path.
Study Design & Planning
We develop study protocols aligned with FDA guidance, ICH requirements, and your clinical objectives.
Execution Oversight
We provide ongoing support during study conduct, helping interpret results and adjust strategy as needed.
IND Package Preparation
We compile your preclinical data into a compelling Module 4 narrative that supports safe clinical dosing.
Frequently Asked Questions
Why Choose Us
- Avoid costly study repeats with FDA-aligned protocols
- Optimize your development timeline with strategic study sequencing
- Build a compelling safety narrative for your IND
- Reduce Pre-IND meeting risk with thorough preparation
- Gain confidence from experienced regulatory insight
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Schedule ConsultationWhat Our Clients Say
"Adelphi's preclinical strategy saved us six months and significant expense. They identified gaps in our original tox plan that would have resulted in a clinical hold. Their guidance on species selection and study design was invaluable."
Dr. Sarah Chen
VP of Research
Emerging Biotech
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