INSIGHTBIO, S.A. conducts first-in-human and early-phase studies for international pharmaceutical sponsors — from FIH and SAD/MAD to bioequivalence and PK/PD studies. ICH E6(R2) GCP compliant. Based in Panama, serving clients globally.
Full-service CRO and SMO capabilities for early-phase pharmaceutical development.
First-in-human, SAD/MAD, and early-phase studies with full inpatient confinement and 24/7 medical supervision.
Pharmacokinetic and pharmacodynamic profiling, bioavailability and bioequivalence studies, NCA and PK/PD modelling.
Complete site management for international sponsors: feasibility, IEC submission, initiation, monitoring, and close-out.
Own data management system, EDC build and validation, SAP development, PK NCA, and final TLF production.
IND/CTA submissions, IEC dossier preparation, safety reporting, and regulatory agency meeting support.
Dedicated inpatient beds, ICU, and 24/7 physician coverage for first-in-human and confinement studies.
In-house hematology, biochemistry, urinalysis, and coagulation analysis — ensuring sample integrity and rapid turnaround.
Every clinical and data team member holds current GCP certification. Principal Investigators are board-certified physicians with Phase I experience.
Established IEC operating per ICH E6 and Panamanian bioethics regulations. Typical review timeline: 3–4 weeks.
Proven track record with sponsors from UAE, Hong Kong, and the USA.
Dedicated IP storage with temperature monitoring, restricted access, and full dispensing accountability.
Board-certified PIs with extensive Phase I experience across multiple therapeutic areas and sponsor types.
From study design and regulatory submission through data management, analysis, and final Clinical Study Report — one team, full accountability.
Send us your study synopsis and we will respond within 5 business days with site capabilities, volunteer recruitment strategy, and an indicative budget.
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