Early-phase medical device clinical trials in Panama
Welcome to First in Humans
First in Humans is a specialized Clinical Research Organization (CRO) dedicated to supporting human clinical trials for medical devices in Panama, Central America. We provide end-to-end clinical trial facilitation, helping sponsors navigate local regulatory pathways efficiently while maintaining the highest ethical and safety standards.
Our Core Services
Principal Investigator & Site Identification
- Identification and qualification of experienced Principal Investigators (PIs)
- Site feasibility assessments aligned with device indication and protocol requirements
- Access to leading private and public hospitals across Panama
Regulatory & IRB Submissions
- Full coordination and preparation of:
- Ministerio de Salud (MINSA) regulatory submissions
- Institutional Review Board (IRB / Comité de Bioética) packages
- Management of submission timelines and responses
- Direct liaison with regulatory authorities and IRB representatives
- Support through approvals, conditions, and amendments
Compliance & Ethical Oversight
- Full compliance with:
- Panamanian clinical research regulations
- CNBI (Comité Nacional de Bioética de la Investigación) requirements
- Good Clinical Practice (GCP) standards
- Ongoing oversight to ensure protocol adherence and subject protection
Study Documentation & Translation
- Professional translation of all study documents into Spanish, including:
- Protocols
- Informed Consent Forms (ICFs)
- Case Report Forms (CRFs)
- Patient materials
- Compliance with Panamanian regulatory and ethical language requirements
- Legal notarization and official stamps as required
Study Startup & Approval Acceleration
- Proactive issue resolution to avoid regulatory delays
- Continuous communication with stakeholders to support timely study initiation
- Startup milestone tracking and reporting
Medical Device Importation & Registration
- Support for medical device registration for clinical use
- Coordination of:
- Import permits
- Customs clearance
- Device receipt and accountability at study sites
- Secure logistics and documentation management
Clinical Operations & Site Support
- Study coordinator and research nurse startup training
- On-site and remote support for:
- Patient recruitment and screening
- Patient monitoring and follow-up
- Data collection and source documentation
- Research nurse management and ongoing operational support
Data Quality & Monitoring
- Real-time data oversight to ensure accuracy and completeness
- Support for sponsor monitoring visits and audits
- Issue escalation and corrective action management