Our Clinical Phase Capabilities
Scientific rigor, patient safety, and regulatory compliance at every trial milestone.
Phase I: First-in-Human & PK
Single and multiple ascending dose (SAD/MAD), pharmacokinetic/pharmacodynamic evaluations, bioavailability studies, and healthy volunteer trials in certified Phase I units.
Phase II: Proof of Concept
Target patient population safety, preliminary therapeutic efficacy, dose-ranging optimization, and biomarker-driven surrogate endpoint measurement.
Phase III: Pivotal Trials
Large-scale global multicenter randomized controlled trials (RCTs), comparative efficacy evaluations, and regulatory dossier preparation for NDA/BLA submission.
Phase IV: Real-World Evidence
Post-authorization safety studies (PASS), long-term pharmacovigilance registries, real-world health economics outcomes research (HEOR), and label expansion.
Study Set-Up & Regulatory Submissions
A successful clinical trial begins with meticulous setup. ASSAY provides end-to-end guidance from protocol feasibility to country-specific ethics approvals.
Study Feasibility Assessment
Submit your planned study parameters for immediate feasibility review across our international site network.
Discuss Your Clinical Protocol with Our Medical Directors
Schedule a confidential consultation to explore country selection, recruitment strategies, and timelines.