Compliance and quality
For Sayo, the quality system is the hard evidence.
Sayo Clinics operates in accordance with Good Clinical Practice (GCP), the ICH E6 guideline, and the Mexican health regulation administered by COFEPRIS.
It built its operation to meet the international standard against which a sponsor qualifies a site, and this page sets out that framework: the regulatory environment, the quality system, and personal data protection.
Regulatory framework
GCP and ICH E6. Sayo operates in accordance with Good Clinical Practice and the ICH E6 (R3) guideline across all research activities.
COFEPRIS. Sayo holds an operating notice (aviso de funcionamiento) with COFEPRIS. Each protocol is conducted only under the specific health authorization COFEPRIS grants for that study.
Designated health officer (responsable sanitario). Sayo has a designated responsable sanitario as required by applicable regulation.
Quality system
Standard operating procedures (SOPs). Sayo developed its SOPs in-house, with external advisor support, covering the essential GCP categories. Procedures are maintained and updated under defined responsibility.
Ethics committee (CEI). Ethical review of each study is conducted through a registered external committee (CEI, the IRB-equivalent in Mexico), designated per protocol.
Systems and training. The team is trained on electronic data capture systems (EDC/eCRF) in common industry use, typically provided by the sponsor.
Document management. Sayo maintains a GCP-compliant document management system with access control and traceability.
Personal data protection
- Sayo processes personal data in accordance with Mexico's federal data protection law (LFPDPPP).
- A designated officer is responsible for personal data processing.
- Purposes, rights, and mechanisms are detailed in the Privacy Notice. See privacy notice
Feasibility