Ethics
Ethics and professional integrity are at the heart of every BioTime project. We strictly adhere to bioethics requirements, ensuring high trust in every stage of our research.
Our quality and compliance system
BioTime implements uncompromising quality management standards that ensure transparency, ethics and reliability at every stage of working with biological samples - from the first contact with the donor to the delivery of the sample to your laboratory.
Corporate Governance and Legal Aspects
- Transparent Structure: Clear legal registration and structured company management model.
- Operational Interaction: Defined areas of responsibility between clinical, laboratory and project teams.
- Internal Oversight: Documentary support and control of each project at all stages of the biospecimen life cycle.
Ethical Standards and Protection of Human Rights
- Regulatory compliance: Work only after approval by the Institutional Review Board or Independent Ethics Committee (IRB/IEC).
- Informed consent: Mandatory signing of the informed consent form (ICF) by each donor before starting any procedures.
- Confidentiality: Complete anonymity of clinical data.
- Donor protection: Strict adherence to international standards of bioethics and human rights protection.
Quality management system (QMS)
- SOP-oriented: Work processes are regulated by standard operating procedures (SOP) for each stage of sample processing.
- Risk management: Implemented deviation control system and CAPA (corrective and preventive actions).
- Continuous improvement: Regular internal audit and optimization of process quality.
Traceability and Logistics
- End-to-end tracking: Complete Chain of Custody from donor consent to final delivery.
- Integrated Logistics: Cold chain operation (dry ice, liquid nitrogen), temperature monitoring and packaging in accordance with IATA standards.
- Specimen Control: Strict labeling, processing, storage and shipping procedures.
Clinical Network and Monitoring
- Centre Qualification: Careful selection of partner clinics and experienced Principal Investigators (PIs).
- Professional Training: Systematic training of personnel involved in the collection of biomaterials, taking into account the specific requirements of the customer.
Audit and transparency: the foundation of our trust
We are open to inspections and cooperation. We have successful experience working with companies from the USA, Canada, Europe and Japan.
- Openness: Possibility of conducting client audits of our centers.
- Direct communication: We provide access to direct communication with the principal investigators.
- Zero Tolerance: Our anti-corruption and anti-sanctions principles are an integral part of BioTime’s corporate culture.
