Services

As a Contract Research Organization (CRO) with deep expertise in Latin America, we offer full-service clinical trial support to pharmaceutical companies, biotech firms, medical device developers, and academic institutions. Our goal is to streamline drug and medical device development through strategic execution, regulatory alignment, and operational excellence—specifically adapted to the unique dynamics of the LATAM region.

Clinical Trial Management

We manage every phase of the clinical trial lifecycle with precision and regional insight:

  • Protocol Development: Scientifically sound and operationally feasible protocols aligned with LATAM regulatory and clinical practice standards.
  • Project Management: Comprehensive trial coordination including timelines, KPIs, risk mitigation, and performance tracking.
  • Site & Investigator Selection: Access to high-performing research centers and experienced investigators across LATAM countries (Argentina, Brazil, Mexico, Colombia, Chile, Peru, etc.).
  • Site Start-Up & Activation: Fast-track processes for site contracts, ethics submissions, and budget negotiations—minimizing delays

Regulatory Affairs

Navigating LATAM regulatory frameworks requires both expertise and strong local relationships. Our services include:

  • Regulatory Strategy: Country-specific guidance for submissions to agencies such as ANMAT (Argentina), ANVISA (Brazil), COFEPRIS (Mexico), INVIMA (Colombia), and others.
  • Health Authority Submissions: Preparation, submission, and follow-up of regulatory dossiers.
  • Ethics Committee Management: Local IRB/IEC submissions and ongoing coordination for study approvals.
  • Import/Export Licensing: Support for logistics and compliance involving investigational product movement across borders

Clinical Monitoring (CRA Services)

  • On-Site Monitoring: GCP-compliant monitoring visits to ensure data integrity and subject protection.
  • Remote Monitoring: Cost-effective, tech-enabled oversight using secure platforms.
  • Risk-Based Monitoring (RBM): Adaptive monitoring plans focused on study-critical endpoints and site performance.

Data Management & Biostatistics

  • eCRF Design & EDC Implementation: Customized data capture aligned with protocol objectives and LATAM operational conditions.
  • Data Cleaning & Validation: Continuous data quality assurance to ensure reliable outcomes.
  • Statistical Analysis: Study design consultation, statistical plans, and interpretation in line with ICH E9 and regulatory expectations.

Medical Writing

    • Regulatory Documentation: Protocols, Investigator Brochures, Informed Consent Forms, and Clinical Study Reports (CSRs).
    • Scientific Writing: Manuscripts, abstracts, and conference presentations tailored to LATAM data and findings.
    Multilingual Support: Documents available in English, Spanish, and Portuguese with regionally appropriate terminology

Pharmacovigilance & Drug Safety

  • SAE/AE Management: Real-time processing and reporting of serious adverse events in compliance with local regulations. Safety case intake and processing. SAEs Narratives and translations. Medical review
  • Safety Reporting: DSURs, SUSARs, and periodic reports adapted to national health authority formats.
  • Risk Management Plans (RMPs): Regional tailoring of global safety strategies for LATAM settings.
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Site Support & Training

  • GCP & Protocol Training: Investigator and site staff training in compliance with ICH-GCP and local ethics requirements.
  • Site Management: Ongoing communication and performance oversight to enhance recruitment and retention.

Patient Engagement Strategies: Culturally adapted approaches to maximize enrollment and retention across LATAM populations

Logistics & Supply Chain Management

  • Importation & Distribution: End-to-end management of investigational product logistics, including customs clearance and storage.
  • Temperature-Controlled Shipments: Regional partnerships with GxP-certified couriers and depots.
  • Laboratory Sample Handling: Coordination of biological sample collection, shipment, and lab analysis in compliance with export permits

Quality Assurance & Auditing

  • GCP Audits (Sites, Systems, Vendors): Risk-based audit plans tailored to regional regulatory expectations.
  • Inspection Readiness: Preparation for inspections by local or global regulatory authorities.
  • SOP Development & Compliance Training: Internal quality systems tailored to local team capabilities and sponsor requirements.

Strategic Consulting & Feasibility

  • LATAM Feasibility Assessments: Country and site-level feasibility including patient availability, investigator engagement, and regulatory timelines.
  • Market Entry Support: Advisory for sponsors new to the region, including legal, ethical, and logistic considerations.
  • Trial Rescue & Turnaround: Operational support for delayed or underperforming studies needing rapid corrective action.
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