Is Your Biotech Program Ready for First-in-Human?
A Development Strategy, Nonclinical, CMC & Clinical Readiness Self-Assessment for biotech teams preparing for their first clinical trial.
18 questions · ~7 minutes · Instant results
Important: This checklist provides a non-binding, informational readiness assessment only. It does not constitute regulatory advice.
Why Use This Readiness Checklist?
Entering first-in-human is a major milestone for any biotech program. The difference between a smooth CTA approval and a delayed, resource-intensive one often comes down to preparation.
Development Strategy & Regulatory Pathway
TPP alignment, legal basis, integrated workstream planning, Scientific Advice.
Nonclinical Package Readiness
Species justification, in vivo vs. alternative methods, starting dose strategy, comparability.
CMC & Manufacturing Readiness
Characterization, process control, stability, CMC/clinical timeline alignment.
The assessment also covers Clinical Trial Application & Governance readiness, including CTIS submission, sponsor oversight, safety governance and FIH site selection.
How to Use This Checklist
Select the option that most honestly reflects where your program stands today. This checklist surfaces the gaps that most commonly delay CTAs, so you can prioritize where support matters most.
On track
Foundations in place.
In progress
Known gaps remain.
Not yet addressed
Potential risk.
Ready to Check Your Readiness?
Complete the 7-minute checklist to receive your readiness tier and a per-section breakdown across strategy, nonclinical, CMC and clinical governance.