We operate in accordance with the strictest ethical guidelines
Governance & Legal Structure
• Clear legal entity registration and governance structure
• Defined operational responsibilities across clinical, laboratory, and project management teams
• Documented internal oversight for all biospecimen projects
• Clear legal entity registration and governance structure
• Defined operational responsibilities across clinical, laboratory, and project management teams
• Documented internal oversight for all biospecimen projects
Ethics, Consent & Human Subject Protection
• All clinical materials are obtained exclusively following approval by an Institutional Review Board or Independent Ethics Committee (IRB/IEC)
• All donors provide informed consent and sign an Individual Consent Form prior to participation
• All clinical data are fully anonymized prior to sharing
• Strict adherence to international standards for the protection of human subjects
• All clinical materials are obtained exclusively following approval by an Institutional Review Board or Independent Ethics Committee (IRB/IEC)
• All donors provide informed consent and sign an Individual Consent Form prior to participation
• All clinical data are fully anonymized prior to sharing
• Strict adherence to international standards for the protection of human subjects
Quality Management System
• SOP-driven workflows covering all stages of the biospecimen lifecycle
• Controlled deviation management and Corrective and Preventive Action (CAPA) system
• Continuous internal quality review and process improvement
• SOP-driven workflows covering all stages of the biospecimen lifecycle
• Controlled deviation management and Corrective and Preventive Action (CAPA) system
• Continuous internal quality review and process improvement
Sample Traceability & Chain of Custody
• Full traceability from donor consent to final sample delivery
• Documented chain of custody for all biospecimens
• Controlled labeling, processing, storage, and shipment procedures
• Full traceability from donor consent to final sample delivery
• Documented chain of custody for all biospecimens
• Controlled labeling, processing, storage, and shipment procedures
Clinical Site Oversight
• Qualified clinical site selection and monitoring
• Engagement with experienced principal investigators
• Training of clinical and laboratory personnel involved in sample collection
• Certified, experienced professionals with a deep understanding of client requirements
• Qualified clinical site selection and monitoring
• Engagement with experienced principal investigators
• Training of clinical and laboratory personnel involved in sample collection
• Certified, experienced professionals with a deep understanding of client requirements
Temperature Control & Logistics
• Validated cold chain logistics (dry ice / liquid nitrogen / other conditions)
• Temperature monitoring during storage and shipment upon request
• Packaging procedures in accordance with IATA recommendations to maintain sample integrity
• Validated cold chain logistics (dry ice / liquid nitrogen / other conditions)
• Temperature monitoring during storage and shipment upon request
• Packaging procedures in accordance with IATA recommendations to maintain sample integrity
Audit Readiness & Transparency
• Clinical sites and processes are available for client audits upon request
• Direct communication with principal investigators can be arranged
• Audit experience with clients from the US, Canada, Europe, and Japan
• Transparency as a core principle of trust
• Clinical sites and processes are available for client audits upon request
• Direct communication with principal investigators can be arranged
• Audit experience with clients from the US, Canada, Europe, and Japan
• Transparency as a core principle of trust
Compliance Statements
• BIOMEDICA CRO maintains an internal Quality Management System (QMS) designed to meet industry-standard expectations for CRO operations
• Anti-bribery, sanctions, and ethical conduct principles are embedded in company operations
• BIOMEDICA CRO maintains an internal Quality Management System (QMS) designed to meet industry-standard expectations for CRO operations
• Anti-bribery, sanctions, and ethical conduct principles are embedded in company operations
