Services — INSIGHTBIO, S.A. Phase I CRO & SMO

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Phase I Studies — Full CRO Services

We conduct Phase I clinical studies as a full-service CRO — taking complete operational responsibility from protocol development through final Clinical Study Report.

First-in-Human (FIH) studies with full inpatient confinement
Single Ascending Dose (SAD) and Multiple Ascending Dose (MAD) studies
Bioavailability (BA) and Bioequivalence (BE) studies
Food-effect, drug-drug interaction (DDI), and mass balance studies
PK/PD profiling and dose-exposure-response modelling
Turnkey research from study synopsis to final CSR

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SMO — Site Management Organization

INSIGHTBIO operates as an SMO for international sponsors and CROs wishing to conduct Phase I studies at our site or through affiliated investigational sites in Panama and the region.

Site feasibility assessment and pre-study site evaluation
IEC/IRB submission and approval management
Site initiation, staff training and GCP qualification
Remote (RMM) and on-site monitoring — SDV and SDR
Protocol deviation tracking and CAPA management
Investigational product management and accountability
Study close-out and site decommissioning

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Data Management & Biostatistics

Our own data management infrastructure ensures full data traceability, audit trail compliance, and clean dataset delivery to sponsors.

Own data management system with full audit trail (21 CFR Part 11 compliant)
EDC build, validation and deployment — Medidata Rave and CRIO compatible
Statistical Analysis Plan (SAP) development and review
Sample size and power calculations
PK non-compartmental analysis (NCA) and PK/PD modelling
Final tables, listings and figures (TLF) per ICH E3

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Regulatory Affairs

Strategic regulatory support for Phase I study submissions and ongoing compliance.

IND, CTA and Phase I notification submissions
Independent Ethics Committee (IEC) dossier preparation and submission
Safety reporting: SAE narratives, expedited reports and DSURs
Regulatory agency meeting support (pre-IND, Type B, scientific advice)
Orphan drug designation, Fast Track and Breakthrough Therapy applications
GCP compliance audit and regulatory gap analysis

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Medical Writing

High-quality Phase I scientific and regulatory documents prepared in full compliance with ICH E3, ICH E6(R2) and applicable FDA/EMA formatting requirements.

Phase I Clinical Study Protocol (CSP) and amendments
Investigator's Brochure (IB) and IB updates
Clinical Study Reports (CSR) per ICH E3
Informed Consent Forms (ICF) and Patient Information Sheets
Pharmacokinetic reports and NCA write-ups
Regulatory overviews and CTD module summaries

Infrastructure

Phase I Unit — Site Capabilities

Our inpatient Phase I unit is fully equipped for confinement studies, intensive PK sampling, and 24/7 medical supervision.

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Clinical Infrastructure

Inpatient beds for 24/7 confinement study conduct
ICU on-site with 24/7 physician on duty
Full resuscitation and emergency response equipment
ECG, spirometry, tonometers, centrifuges, ultrasound
Dedicated drug storage, dispensing and documentation rooms

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PK Sampling & Data Systems

Synchronized electronic timekeeping for accurate PK sample time recording
Own analytical laboratory: hematology, biochemistry, urinalysis, coagulation
Certified refrigerators and freezers for biological sample storage
Video surveillance and calling system for volunteer monitoring
Protocol-compliant nutrition service with qualified nutritionist

Phase I Clinical Research Services